The Tanzania Medicines and Medical Devices (List of Registered and Cancelled Medicines) Notice, 2020

1. This notice may be cited as the Tanzania Medicines and Medical Devices (List of Registered and Cancelled Medicines) Notice, 2020. Notification of approval

2.-(1) The list of the registered human medicinal products shall be as set out in the First Schedules to this Notice. (2) The list of registered veterinary medicinal 1 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Products shall be as set out in the Second Schedule to this Notice. (3) The list of cancelled medicines shall be as set out in the Third Schedule to this Notice. 2 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) MINISTRY OF HEALTH,COMM UNITY DEVELOPMENT,GENDER,ELDERY & CHILDREN TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY P.O. Box 1253 , Dodoma, Tanzania Tel: +255 26 2961989 , 2061 ,990 Fax: +255 22 2450793 Website: www.tmda.go.tz, Email: info@tmda.go.tz LIST OF REGISTERED HUMAN MEDICINAL PRODUCT S/ N Registration Brand Name INN Name Dosage Form Number Product Strength Manufacturer Country Registrant: ABACUS PARENTERAL DRUGS LIMITED (APDL), UGANDA 1 TZ 19 H 0393 ABBORI Boric Acid Ear Drops

1.83 %w/ v ABACUS PARENTE RAL DRUGS LTD (APDL) Registrant: ABACUS PARENTERAL DRUGS LTD (APDL), UGANDA 2 TZ 19 H 0404 ABCROM Sodium Cromoglicate

2.0 w/ v Ophth almic Soluti on Registrant: Abacus Pharma Africa LTD, Tanzania 3 TZ 14 H 0214 Ampimax - 500 Ampicilli n Powder for solution for injection 500 mg ABACUS PARENTE RAL DRUGS LTD (APDL) Reyoung Pharm aceutical Company Limited UGANDA UGANDA CHINA Registrant: ABBOTT LABOLATORIES S.A (PTY) LTD, SOUTH AFRICA 4 5 TZ 19 H 0348 KLACID 500 Clarithr omycin TZ 19 H 0344 KLACID XL Clarithr omycin Tablet, Film- coated Film Coated Tablet 500 mg Abbvie S.R.L ITALY 500 mg Abbvie S.R.L ITALY Registrant: Abbott Laboratories S.A (Pty) Ltd., SOUTH AFRICA 6 TZ 14 H 0271 Hid rasec Infant s Racecadotr il Granules for Oral suspension 10 mg Laboratories SOPHARTEX FRANCE 7 TZ 14 H 0190 Faverin Fluvoxamine Tablets 100 mg Mylan Laboratories SAS FRANCE 3 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 8 9 TZ 14 H 0230 TZ 19 H 0408 Hid rasec 100 mg Hard Betaserc 24 Capsul es Racecadotr il Capsules 100 mg Laboratoires Sophart ex FRANCE Betahistine Dihydrochloride Tablets 24 mg/ tablet Mylan Laboratories SAS FRANCE Registrant: ACME Laboratories Limited, Bangladesh 10 TZ 19 H 0338 CIPRO-A EYE DROP, 5ML Ciprofloxacin Hydrochloride Registrant: Aculife Healthcare Private Limited, INDIA 11 TZ 15 H 0001 Nirm et Metr onidazole Op hth alm ic Sol uti on Infusion 3 mg ACME Laboratories Limited Bangladesh 500 mg/ 100 ml Aculife Health care Private Limited INDIA Registrant: Adwia, EGYPT 12 TAN 05 ,020 G02 A EGY Vagiprost Misoprostol Tablets 40 mg/ ml EGYPT Egyptian Co. for Chemicals & Pharm aceuticals S.A.E Registrant: AGOG Pharma Limited, INDIA 13 TZ 19 H 0266 AGODOX Doxycycline Capsules Capsules 100 mg Agog Pharm a Limited INDIA Registrant: Ajanta Pharma Limited, INDIA 14 TAN 09 ,086 P01B AJA Art efan 40 / 240 Art emeth er + Lum Tablets efantr ine 40 mg + 240 mg Ajant a Pharm a Limited INDIA Registrant: Alkem Laboratories Limited, INDIA 15 16 TZ 14 H 0203 Clavam 625 Amoxicilli n and enzyme inh ibi tor Tablets 625 mg TZ 14 H 0208 CLAVAM 1000 MG Amoxicilli n and enzyme inh ibi tor Tablets 1000 mg Registrant: ALPHACEUTICALS LIMITED , UNITED KINGDOM 17 TZ 19 H 0204 ACE LEVO Levonorgestr el

1.5 mg/ tablet Solid Oral Film Coated Tablet 18 19 TZ 19 H 0246 TZ 19 H 0402 Clopipl av Clopid ogrel Bisulfate 4 Tablet, Film- coated 75 mg Ceflex Cephalexine Monohydrate Capsules 250 mg INDIA INDIA INDIA INDIA INDIA ALKEM LABORATO RIES LIMITED ALKEM LABORATO RIES LIMITED ACME FORMUL ATION PRIVATE LIMITED ZIM LABOR ATORIE S Scott Edil LIMITE Advanced D Research Laboratories & Education Limited Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: AMRING FARMA S.R.L, Romania 20 TZ 19 H 0258 RITUXIMAB AMRING Rituximab 21 TZ 19 H 0257 RITUXIMAB Rituximab AMRING 22 TZ 19 H 0354 propofol amr ing Propofol 23 TZ 19 H 0286 Zoledronic Acid zoledronic acid Amr ing Solution For Infussion Solution For Infussion Solution For Infussion Solution For Infussion 24 TZ 19 H 0394 Estr inorm Estr iol Pessaries

0.5 mg 25 TZ 19 H 0260 Bevacizum ab Bevacizum ab Amr ing 26 TZ 19 H 0259 Bevacizum ab Bevacizum ab Amr ing Registrant: Aristo Pharmaceuticals Private Limited, INDIA Solution for injection/ concentr a te for solution for Solution infusion for injection/ concentr a te for solution for infusion 500 / 50 mg/ ml m Abxi ence S.A.U ARGENTI NA 100 / 10 mg/ ml m Abxi ence S.A.U ARGENTI NA 10 mg/ ml

0.8 mg/ ml Claris Injectables Limited Claris Injectables Limited FARMAPRIM LIMITED 25 mg/ ml m Abxi ence S.A.U INDIA INDIA REP UBL I C OF MA ARGENTI LDO NA VA 25 mg/ ml m Abxi ence S.A.U ARGENTI NA 27 TAN 05 ,006 V02 C ARI Monocef Ceftr iaxone Sodium Powder 1g for solution for injection Registrant: Astra Lifecare (India) Private Limited, INDIA 28 TZ 19 H 0364 Carbas Carbamazepine Tablets 200 mg Registrant: Astra lifecare (India) Private Limited, INDIA 29 TZ 19 H 0287 cetacaf Paracetamol + Caffeine Tablets 500 mg Registrant: Astra Lifecare (India) Private Limited, INDIA 30 TZ 19 H 0343 Co- Arlum eth er Fort e Art emeth er + Lum efantr ine Tablets 80 / 480 mg Registrant: AstraZeneca UK Limited, UNITED KINGDOM INDIA Aristo Pharm aceuticals Private Limited ASTRA LIFE CARE (INDIA) PRIVATE LIMITED INDIA ASTRA LIFECARE (INDIA) PVT LTD. INDIA Astr a li fecare (India) Private Limited 5 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 31 TAN 00 ,4182 C06 A AST Tenoret 50 Atenolol + Chlorth alid one Tablet, Film-coated 50 mg + 125 mg Astr aZeneca UK Limited UNITED KINGDOM Registrant: AstraZeneca United Kingdom Limited, UNITED KINGDOM 32 TZ 14 H 0226 Zestoretic 20 Lisinopril and Hydrochlorohiazide Tablets 20 mg + 12 .5mg Astr aZeneca United Kingdom Limited UNITED KINGDOM Registrant: Aurobindo Pharma Limited, INDIA 33 TZ 19 H 0390 PACSITA 150 Capecitabine Film Coated Tablet 150 mg Eugia Pharm a Specialties Limited INDIA 34 TZ 19 H 0398 Dolutegravir 50 / 300 / 300 mg Aur obindo INDIA , Lamivudine and Tenofovir Disoproxil Fum arate TZ 19 H 0389 PACSITA 500 Dolutegragravir + Emtr icitabine + Tenofovir Alafenamide Tablet, coated Capecitabine USP Tablet, coated 500 mg TAN 00 ,4581 J 01D AUR Aur oxone Ceftr iaxone Powder 1000 mg/ vial 35 36 Pharm a Limited, (Unit XI) Eugia Pharm a Specialties Limited Aur obindo Pharm a Limited (Unit VI) AUROBINDO PHARMA Limited Aur obindo Pharm a Limited (Unit III ) Aur obindo Pharm a Limited (unit XII) Aur obindo Pharm a LIMITED INDIA INDIA INDIA INDIA INDIA INDIA Pharm a Private Limited Aur obindo Pharm a Limited INDIA Aur obindo Pharm a LIMITED Aur obindo Pharm a LIMITED INDIA INDIA 500 mg + 500 mg Aur onext INDIA 37 TZ 19 H 0183 Topraz 20 Pant oprazole Tablets 20 mg 38 TZ 19 H 0310 AURASERT 50 Sertr aline Tablet, coated Sert aline hydrochlorid e 50 mg 39 TZ 19 H 0231 SUMAFIX 50 sum atr iptan succinate Tablets 50 mg 40 TZ 14 H 0247 Rofast 20 Rosuvastatin Tablets 20 mg 41 TZ 14 H 0299 Inemplus 500 Imipenem and enzyme inh ibi tor Powder for solution for injection 42 TZ 19 H 0230 AROXICAM 7.5 Meloxicam Tablets

7.5 mg 43 TZ 14 H 0246 Rofast 10 Rosuvastatin Tablets 10 mg 44 TZ 19 H 0221 PEGASET 75 Pregabalin Capsules, hard 75 mg 6 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: B&O PHARM, FRANCE 45 TZ 19 H 0281 NODIAR Diosmectite Powder for Oral solution 3 g Registrant: BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED 46 TAN 05 ,068 PROVIVE Propofol N02 A CLA Solution for injection 1% w/ v Registrant: Bayer East Africa Limited, KENYA CHINA , INDIA INDIA Simcere Pharm aceutical Company Limited BAXTER PHARMAC EUTICALS INDIA PRIVATE LIMITED 47 TZ 19 H 0251 MICROGYNON ED Registrant: Bayer Healthcare AG, GERMANY 48 TAN 00 ,4527 Levitr a C04 A BAY Registrant: Beta Healthcare International Limited, KENYA 49 TAN 00 ,535 N02B BEH Action Registrant: BEXIMCO PHARMACEUTICALS LIMITED, Bangladesh 50 TZ 19 H 0400 Olopan Eye Drops Registrant: Bharat Biotech International Limited, 51 TZ 19 H 0288 Rotavac L e v o n o r Vardenafil g Hydrochloride e s t r Acetylsalicylic e Acid + Caffeine l + Paracetamol a n d Olopatadine Hydrochloride e t h i n Rotaviru s vaccine y l e s t r Tablets 150 ,30 mcg Bayer AG GERMANY Tablets 5mg Bayer Health care AG GERMANY Tablets 600 mg + 50 mg + 300 mg Beta Health care Int ern ational Limited KENYA Opth almic Suspension 1 mg/ ml Bangladesh BEXIMCO PHARMACE UTICALS LIMITED Liquid in frozen form

0.5/ 2.5/ 5.0 ml/ vial INDIA BHARAT BIOTECH INTERNATIO NAL LIMITED. Registrant: BHARAT BIOTECH INTERNATIONAL LIMITED., INDIA 52 TZ 19 H 0340 Typbar TCV a d i o l Suspension for injection

0.5/ 0.5/ 2.5 ml/ vial INDIA BHARAT BIOTECH INTERNATIO NAL LIMITED. Registrant: BIODEAL PHARMACEUTICALS PVT. LTD., INDIA 53 TZ 19 H 0284 Emina mu pro Mupirocin Ointm ent 2 % INDIA BIODEAL PHARMACE UTICALS PVT. LTD. 7 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: Bliss GVS Pharma Limited, INDIA 54 TZ 19 H 0201 GACET-125 paracetamol Suppositori es 125 mg 55 TZ 19 H 0200 GACET-250 Paracetamol (Acetaminophen) Suppositori es 250 mg 56 TZ 19 H 0229 VAGID 500 Clotr imazole Pessaries 500 mg Registrant: BRAWN LABORATORIES LIMITED, INDIA 57 TZ 19 H 0315 BRUMOX-500 Amoxicilli n tr Capsules 500 mg ihydrate 58 TZ 19 H 0271 DITS Diclofenac Sodium Injection 75 mg/ 3 ml Registrant: Cadila Healthcare Limited, INDIA 59 TZ 19 H 0253 ZYVAL Valaciclovir Tablets 500 mg INDIA INDIA INDIA INDIA INDIA INDIA BLISS GVS PHARMA LIMITED BLISS GVS PHARMA LIMITED BLISS GVS PHARMA LIMITED BRAWN LABORAT ORIES LIMITED BRAWN LABORAT ORIES LIMITED CADILA HEALTH CARE LIMITED Registrant: Cadila Healthcare Limited , INDIA 60 TZ 19 H 0270 Vomiz 4 Ondansetr on Tablet, Film-coated 4 mg Cadil a Health care Limited INDIA Registrant: Cadila Healthcare Limited, INDIA 61 TAN 00 ,254 Piricam Piroxicam Capsules N02B CAH 62 TAN 09 ,270 C04 Penagra 50 Sild enafil Tablets A CAD Registrant: CADILA PHARMACEUTICALS LIMITED, INDIA 63 TZ 19 H 0326 ROSMI 10 Rosuvastatin Calcium Tablets 10 mg 64 TZ 19 H 0325 ROSMI 20 Rosuvastatin Calcium Tablets 20 mg Cadil a Health care Limited INDIA Cadil a Health care Limited INDIA Cadil a Pharm aceuticals Limited Cadil a Pharm aceuticals Limited INDIA INDIA 8 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Pharm aceuticals Private Limited Chodang Pharm aceutical Company Limited. KOREA Registrant: Centaur Pharmaceuticals Private Limited, INDIA 65 TZ 19 H 0263 Sinarest Linctus Dextr ometh orphan Hydrobromide + Chlorphenira mine Maleate + Menth ol Syru p 10 + 4 mg/ 10 ml Cent aur INDIA Registrant: Chodang Pharmaceutical Company Limited., KOREA 66 TAN 00 ,2166 Amol G D07 C KUW Betameth asone + Clotr imazole + Gent amycin Cream

0.64 mg + 10 mg + 1 mg Registrant: Cipla Limited, INDIA 67 TZ 19 H 0213 LENOSIDE 25 Lenalid omide Capsules 25 mg CIPLA LTD (Goa Unit X) INDIA Registrant: CIPLA LTD, INDIA 68 TZ 19 H 0217 Cipl adon paracetamol Effeverscent 1000 mg Cipl a Limited INDIA Granules Registrant: Cipla Limited, INDIA Enclex 40 69 TAN 09 ,010 B01 Enoxaparin Injection 40 mg Cipl a LIMITED INDIA A CIP 70 TAN 00 ,2530 V03 A CIP Erecto Sild enafil Tablets 50 mg Cipl a Limited INDIA 71 TZ 19 H 0215 lenoside 15 Lenalid omide Capsules, hard 15 mg CIPLA LTD (Goa Unit X) INDIA 72 TZ 19 H 0214 lenoside 10 Lenalid omide Capsules 10 mg CIPLA LTD (Goa Unit X) INDIA 73 TAN 09 ,011 B01 Enclex 60 Enoxaparin Injection 60 mg/ 06 ml Cipl a Limited INDIA A CIP Registrant: Cipla Ltd, INDIA 74 TZ 19 H 0372 75 TZ 19 H 0337 76 TZ 19 H 0247 Dolutegravir / Lamivudine/ Tenofovir Disoproxil Fum arate Efavirenz/ Lamivudine/ Ten Disoproxil Fum arate 600 mg/ 300 mg/ 300 mg ofovir Efavirenz, Lamivudin e & Tenofovir Disoproxil Fum arate Tablets 600 / 300 / 300 mg Dolutegravir Sodium Lamivudine Tenofovir Disoproxil Fum arate Efavirenz, Lamivudine & Tenofovir Disoproxil Fum arate Efavirenz, Lamivudine & Tenofovir Disoproxil Fum arate Tablets 650 mg Cipl a limited, (Goa Unit VII PD II) INDIA Tablets 600 / 300 / 300 mg Cipl a limited, (Goa Unit VII PD II) INDIA Tablets 600 / 300 / 300 mg Cipl a limited, (Goa Unit VII PD II) INDIA Registrant: CIPLA QUALITY CHEMICAL INDUSTRIES LTD, UGANDA 9 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 77 TZ 19 H 0407 Texavir Tenofovir Tablet, coated 300 mg Registrant: Coral Laboratories Limited., INDIA 78 TZ 19 H 0272 Folic Acid Folic Acid Oral tablet 5 mg 79 TZ 19 H 0261 Dofec Diclofenac Gel 1 %w/ w UGANDA CIPLA QUALITY CHEMICAL INDUSTRIES LTD CORAL LABORATORIE S LIMITED CORAL LABORATORIE S LIMITED INDIA INDIA Registrant: Cosmos Limited, KENYA 80 TAN 00 ,2318 A02B COS Cemet Cimetidi ne Tablets 400 mg Cosmos Limited KENYA Registrant: Dafra Pharma Limited, KENYA 81 TAN 00 ,1967 P01B DAF Art esiane 80 Art emeth er Injection 80 mg/ ml 82 TAN 00 ,1968 P01B DAF Art emeth er Paediatr ic Art emeth er Solution 20 mg/ ml GERMANY GERMANY Rotexmedica GmbH Arzneimitt elwerk Rotexmedica GmbH Arzneimitt elwerk Registrant: Dawa Limited, KENYA 83 TZ 19 H 0262 Combilli n Ampicilli n (As tr ihydrate ) & Cloxacilli n (As sodium ) Powder for Oral suspension 125 mg/ 5ml Dawa Limited KENYA Registrant: Denk Pharma GmbH & Co. KG, GERMANY 84 TZ 14 H 0245 Carvedi-D enk Carvedil ol Tablets 25 mg 25 85 TAN 09 ,126 N02B E.D Para Co-Denk 500 / 30 Paracetamol + Codeine Tablets 500 mg + 30 mg 86 TZ 14 H 0253 Clopi-D enk 75 Clopid ogrel Tablet, coated 75 mg 87 TZ 14 H 0217 Flucona-Denk Fluconazole Tablets 100 mg 100 88 TZ 14 H 0241 Metform in- Denk Metform in Hydrochloride Tablet, coated 1000 mg 89 TZ 19 H 0371 Tramado l Denk 100 mg Retard Tramadol Hydrochloride Tablets 100 mg 90 TZ 14 H 0249 Carvedi-D enk Carvedil ol Tablets

6.25 Art esan Pharm a GmbH & Co. KG Bene Avzneimitt el GmbH Art esan Pharm a GmbH & Co. KG Denk Pharm a GmbH & Co. KG Denk Pharm a GmbH & Co. KG Farm aceuticici Form ent i S.P.A Denk Pharm a GmbH & Co. KG GERMANY GERMANY GERMANY GERMANY GERMANY ITALY GERMANY 8 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 91 TZ 14 H 0234 Glimepiride Denk 3 Glimepiride Tablets 3mg 92 TZ 19 H 0370 Tramadol Denk 200 mg Retard Tramadol Hydrochloride Tablets 200 mg 93 TAN 09 ,127 C03 Fur o - Denk 40 Fru semide Tablets 40 mg C E.D 94 TZ 14 H 0279 Toras - Denk 10 Torasemide Tablets 10 mg Registrant: Elys Chemical Industries Limited, KENYA 95 TAN 00 ,1787 Fungistin Nystatin D01 A ELY Suspension, Oral 100000 IU 96 TAN 00 ,4544 R06 A ELY Prometh azine Prometh azine Tablets 25 mg 97 TAN 00 ,2127 R05 C ELY Chestcof Tablets

0.001 ml + 0.002 ml + 10 mg + 0.001 ml +

0.002 ml + 0.02 ml + 35 mg + 0.001 ml Aniseed Oil BP + Eucalyptus Oil BP + Menth ol BP + Pepperm int Oil BP + Creosote BP + Capsicum BP + Glycyrrh iza Extr act BP + Fine Pum ili o Oil BP 98 TAN 00 ,1974 J 01 A ELY Elytetr a Tetr acycline Ointm ent 3 % w/ v 99 TAN 00 ,4546 Chlorpromazine Chlorpromazine Tablets 100 mg N04 A ELY 100 TAN 00 ,1774 Hedapan M01 A ELY Acetylsalicylic Acid + Caffeine + Paracetamol Tablets 300 mg + 30 mg + 250 mg 101 TAN 00 ,4543 Ascorbic Acid Ascorbic Acid Tablets 100 mg A11 G ELY 102 TAN 00 ,1799 J 01 A ELY Doxycycline Doxycycline Capsules 100 mg 103 TAN 00 ,4545 Folic Acid Folic Acid Tablets 5 mg B03 A ELY GERMAN Y ITALY GERMAN Y GERMAN Y KENYA KENYA KENYA KENYA KENYA KENYA KENYA KENYA KENYA Denk Pharm a GmbH & Co. KG Farm aceuticici Form ent i S.P.A Denk Pharm a GmbH & Co. KG Denk Pharm a GmbH & Co. KG Elys Chemical Industr ies Limited Elys Chemical Industr ies Limited Elys Chemical Industr ies Limited Elys Chemical Industr ies Limited Elys Chemical Industr ies Limited Elys Chemical Industr ies Limited Elys Chemical Industr ies Limited Elys Chemical Industr ies Limited Elys Chemical Industr ies Limited Registrant: Emcure Pharmaceuticals Limited, INDIA 9 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 104 TZ 14 H 0204 Asomex - D amlodipi ne and diur etic Tablets

2.5mg + 12 .5mg Emcur e INDIA 105 TZ 14 H 0283 Proxym-300 Etodolac Tablet, Film-coated 300 mg Registrant: ESKAYEF PHARMACEUTICALS LIMITED, BANGLADESH 106 TZ 19 H 0321 Metco IV Metr onidazole Infusion 500 mg Registrant: Eva Pharma for Pharmaceuticals and Medical Appliances, EGYPT 107 TZ 19 H 0339 Flopadex Silodosin Capsules 8 mg 108 TZ 19 H 0355 Donifoxate Febuxostat 80 mg Tablets 80 mg 109 TZ 19 H 0216 Prostetr ol Alfuzosin HCl Film Coated Tablet 10 mg Pharm aceuticals Limited EMCURE PHARMACE UTICALS LIMITED INDIA ESKAYEF PHARMACE UTICALS LIMITED BANGLA DESH EGYPT EGYPT EGYPT Eva Pharm a For Pharm aceuticals & Medical Appli ances Eva Pharm a for Pharm aceuticals and Medical Appli ances Eva Pharm a for Pharm aceuticals And Medical Appli ances Registrant: FDC LIMITED, INDIA 110 TZ 19 H 0387 Electr al- Z Kit Registrant: FDC Limited, INDIA Oral Rehydrati on Salt/ Zinc Sulfate Tablets Tablets

2.90 + 13 .50 +20 g FDC Limited INDIA 111 TZ 19 H 0190 Bactigen Eye/ ear Drops Gent amycin Sulphate Ear/ Eye Drops

0.3 %w/ v FDC Limited INDIA 112 TZ 19 H 0324 Zo ofloxacin Ear Drops

0.3 %w/ v FDC Limited INDIA Registrant: Fourrts (India) Laboratories Private Limited, INDIA 113 TAN 09 ,136 J 02 Fungistop Fluconazole Capsules 150 mg A FOU INDIA Fourr ts (India) Laboratories Private Limited 10 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 114 TAN 09 ,135 A10B FOU Glifil M Fort e Glib enclamide Tablets 5 mg + 50 mg Registrant: Fuda Pharmaceutical Co.Ltd, Tanzania 115 TZ 19 H 0299 Ampcloxa Ampicilli n Trihydrate Capsules 500 mg 116 TZ 14 H 0324 Amoxicilli n Amoxicilli n Capsules 250 mg Trihydrate Registrant: Galentic Pharma (India) Private Limited, INDIA 117 TAN 00 ,4280 J 01B GAL Kloraxin eye ointm ent Chloramphenicol Ointm ent 10 mg/ g 118 TAN 00 ,4551 D07 A GAL Netr acort ointm ent Hydrocort isone Ointm ent 15 mg INDIA Fourr ts (India) Laboratories Private Limited CHINA CHINA REYOUNG PHARMACE UTICAL COMPANY LIMITED CSPC Zhongnuo Pharm aceutical (Shiji azhuang) Company Limited INDIA INDIA Galent ic Pharm a (India) Pvrivate Limited Galent ic Pharm a (India) Pvrivate Limited 119 TAN 00 ,4597 D01 A GAL Whitfield's ointm ent Salicylic Acid + Benzoic Acid Ointm ent 60 mg + 30 mg Galent ic Pharm INDIA a (India) Pvrivate Limited Registrant: Getz Pharma (Pvt) Limited, PAKISTAN 120 TZ 19 H 0265 Salboget Salbutamol Sulphate 100 mcg Pressur ized Inh alation Suspension Getz Pharm a Private Limited PAKISTAN Registrant: Getz Pharma Private Limited, PAKISTAN 121 TZ 19 H 0194 Gabix 300 Gabapent in Capsules 300 mg 122 TZ 19 H 0193 Gabix 100 Gabapent in Capsules 100 mg 123 TZ 19 H 0278 Rovista Rosuvastatin 124 TZ 19 H 0277 Rovista Rosuvastatin 125 TZ 19 H 0276 Rovista Rosuvastatin Tablet, Film- coated 10 mg Tablet, Film- coated 20 mg Tablet, Film- coated 5 mg Getz Pharm a (Pvt) Limited PAKISTAN Getz Pharm a (Pvt) Limited PAKISTAN Getz Pharm a Private Limited Getz Pharm a Private Limited Getz Pharm a Private Limited PAKISTAN PAKISTAN PAKISTAN 11 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: Gilead Sciences, Inc, United States of America 126 TZ 19 H 0233 Epclusa Sofosbuvir Tablet, Film-coated 400 + 100 mg CANADA Path eon Inc, Toront o Regional Operations Registrant: GlaxoSmithKline Limited, KENYA 127 TZ 14 H 0292 Malanil Atovaquone + Proguanil Tablets 250 mg/ 100 mg Glaxo SPAIN Wellcome 128 TAN 09 ,144 J 05 Epivir Lamivudine Solution 10 mg/ ml A GSK GlaxoSmith Kline Inc CANADA Registrant: GlaxoSmithKline pharmaceutical Kenya Limited, KENYA 129 TAN 00 ,1697 N02B SKB Panadol Extr a Caffeine + Paracetamol Tablets 65 mg + 500 mg GlaxoSmith KENYA Kline Limited Registrant: GlaxoSmithKline Pharmaceutical Kenya Limited, KENYA 130 TAN 00 ,4570 Eur ax Crotamiton Cream D04 A NOV Registrant: Glenmark Pharmaceuticals Limited, INDIA 131 TAN 00 ,4599 J 03 C GLE 132 TAN 00 ,4552 A02B GLE Deriva Adapalene Gel

0.1%w/ w Esoz 40 Esomeprazole Tablets 40 mg Registrant: GLENMARK PHARMACEUTICALS LIMITED, INDIA 133 TZ 19 H 0352 POWERCORT OINTMENT Ointm ent

0.5 mg Registrant: Glenmark Pharmaceuticals Limited, INDIA 134 TAN 00 ,4554 A02B GLE Esoz 20 Esomeprazole Tablets 20 mg 135 TAN 00 ,4553 Mili cal A12 A GLE Calcium + Cholecalciferol Tablets 1000 mg + 200 IU 136 TAN 00 ,2340 B03 A GLE Mum fer Chewable Iron (III ) Hydroxid e Polymatose Complex + Folic ac Syru p 100 mg + 500 mg 12 Norvatis Consum er Health SA SWITZER LAND INDIA INDIA Glenm ark Pharm aceuticals Limited Glenm ark Pharm aceuticals Limited INDIA GLENMARK PHARMACE UTICALS LIMITED INDIA INDIA INDIA Glenm ark Pharm aceuticals Limited Glenm ark Pharm aceuticals Limited Glenm ark Pharm aceuticals Limited Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: GSK Pharmaceuticals Kenya Ltd , KENYA 137 TZ 19 H 0227 TIVICAY Dolutegravir Sodium Tablets 25 mg 138 TZ 19 H 0226 TIVICAY Dolutegravir Sodium Tablets 10 mg Glaxo Operations UK (Trading as Glaxo wellcome Operations) Glaxo Operations UK (Trading as Glaxo wellcome Operations) Registrant: GUILIN PHARMACEUTICAL (SHANGHAI) CO., LTD, CHINA 139 TZ 19 H 0386 GUFRUSEMID Fur osemide BP Solution for injection 20 / 2 mg/ ml Gland Pharm a Limited Registrant: Guilin Pharmaceutical Shanghai Co. Limited, CHINA 140 TZ 19 H 0274 Gutaxime Cefotaxime Sodium Powder for solution for injection 1 g Registrant: Guilin Pharmaceuticals Company Limited, 141 TZ 14 H 0269 Gent amicin Gent amicin Solution 80 mg sulfate Registrant: Gulf Pharmaceutical Industries (Julphar), UNITED ARAB EMIRATES 142 TZ 19 H 0376 Xemaderm Mometasone fur oate Ointm ent

0.1 % U N I T E D U N K I I T N E G D D O K M INDIA I N G D O M CHINA REYOUNG PHARMACEUT ICAL COMPANY LIMITED CHINA GUILI N PHARMACEUT ICAL COMPANY Limited U.A.E Gulf Pharm aceutical Industr ies- Julphar Unit-X Registrant: H.Lundbeck A/ S, DENMARK 143 TZ 14 H 0318 Clopix ol - Acuphase Zuclopenth ixol Solution for injection 50 mg/ ml H. Lundbeck A/ S DENMAR K 144 TZ 14 H 0288 Clopix ol Depot Zuclopenth ixol Solution for injection 200 mg/ ml H.Lundbeck A/ S DENMAR K Registrant: Hetero Biopharma Limited, INDIA 145 TZ 19 H 0240 BEVAAS 400 Bevacizum ab Solution for injection 146 TZ 19 H 0239 BEVAAS 100 Bevacizum ab Solution for injection 100 / 4 mg/ ml 13 400 / 16 mg/ ml Hetero INDIA Biopharm a Limited Hetero Biopharm a Limited INDIA Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: Hetero Laboratories Limited, INDIA 147 TZ 19 H 0237 IRBIS-H 150 Irbesart an Tablets 150 + 12 .5 mg Hetero Labs INDIA Limited 148 TZ 19 H 0236 Irbis - HT 300 /

12 .5 Irbesart an and Hydrochloroth iazide Tablets Tablets 300 + 12 .5 mg Hetero Labs INDIA Limited 149 TZ 19 H 0380 Prega 75 mg Pregabalin Capsules 75 mg Tablets 75 mg 150 TZ 19 H 0379 Prega 150 mg Pregabalin Capsules 150 mg Tablets 150 mg 151 TZ 14 H 0209 Penvir 500 Famciclovir Tablets 500 mg Hetero Labs Limited (Unit III ) Hetero Labs Limited (Unit III ) INDIA INDIA HETERO LABS LIMITED (UNIT V) INDIA 152 TZ 14 H 0188 153 TZ 15 H 0023 Emtr icita bine and Teno fovir Pant in 40 Diso proxi l Fum arate Registrant: Hetero Labs Limited, INDIA Emtr icitabine and Tenofovir Disoproxil Fum arate Pant oprazole Tablets 200 mg + 300 mg Hetero INDIA Laboratories Limited Tablets 40 mg HETERO LABS LIMITED (UNIT V) INDIA 154 TZ 19 H 0397 STAVANCE 500 Vancomycin Injection 500 mg Hydrochloride USP 155 TZ 19 H 0312 LISOF Tablets 900 / 400 mg ledip asvir 90 mg/ sofosbuvi r 400 mg 156 TZ 19 H 0396 STAVANCE 1 Vancomycin Hydrochloride USP Registrant: Immacule Lifescience Private Limited, INDIA 157 TZ 19 H 0374 IMSO Esomeprazole Sodium 1 g Lyophili zed Powder for Injection Lyophili zed Powder for Injection ASPIRO PHARMA LIMITED Hetero Labs Limited, Unit- V ASPIRO PHARMA LIMITED INDIA INDIA INDIA 40 mg Imm acule Lifesciences Private Limited INDIA Registrant: Ind-Swift Limited, INDIA 158 TZ 19 H 0328 Swamlo 5 Amlodipi ne Tablets 5 mg Ind- Swift Limited INDIA 14 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) TZ 19 H 0327 Swamlo 10 Amlodipi ne Tablets 10 mg 15 9 Ind- Swift Limited INDIA Registrant: INDCHEMIE HEALTH SPECIALITIES PVT. LIMITED, INDIA 16 0 TZ 19 H 0292 MUPIROCIN OINTMENT Mupirocin Ointm ent

2.0% w/ w INDIA INDCHEMIE HEALTH SPECIALITIES PVT. LIMITED Registrant: Indoco Remedies Limited, INDIA 16 1 TAN 09 ,148 A02 A IND Viscid Alum ium Hydroxid e + Magnesium Hydroxid e + Simeth icone Gel 100 mg +400 mg + 25 mg Indoco Remedies Limited TZ 19 H 0395 Pregabalin Pregabalin Capsules 75 mg 16 2 16 3 TAN 00 ,2348 G04B IND Cital Disodium Hydrogen Syru p 137 mg/ 5ml Indoco Remedies Limited Indoco Remedies Limited INDIA INDIA INDIA Registrant: INFUGEN PHARMA PVT. LTD., INDIA TZ 19 H 0381 16 4 INFUMOX CV

156 .25 Amoxicilli n + Clavulanic acid Suspension, Oral

156 .25 mg/ 5ml Medopharm INDIA Private Limited Registrant: INTAS PHARMACEUTICALS LIMITED, INDIA 16 5 TAN 00 ,731 C01E INT Losart as 50 Losart an Tablets 50 mg TZ 14 H 0307 Tort as 10 Torasemide Tablets 10 mg TZ 19 H 0268 CLAVIX - 75 Clopid ogrel Bisulphate Tablet, Film-coated 75 mg TZ 14 H 0321 Tort as 20 Torasemide Tablets 20 mg 16 6 16 7 16 8 Registrant: IPCA Laboratories Limited, INDIA 16 9 TAN 00 ,156 R05D IPC Solvin Bromh exine Elixi r 4 mg/ 5ml Registrant: Janssen Pharmaceutica Proprietary Limited, SOUTH AFRICA 17 0 TAN 00 ,119 A04 A JAN Motili um Domperidone Suspension, Oral 1 mg/ ml Int as Pharm aceuticals Limited Int as Pharm aceuticals Limited Int as Pharm aceuticals Limited Int as Pharm aceuticals Limited INDIA INDIA INDIA INDIA IPCA Laboratories Limited INDIA BELGIUM JANSSEN CILAG INTERNATION AL NV 15 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: Janssen- Cilag International NV, BELGIUM 171 TZ 14 H 0242 Prezista 75 mg Darun avir Tablet, Film-coated 75 mg Janssen Cilag SpA ITALY 172 TZ 14 H 0252 Prezista 150 mg Darun avir Film Coated Tablet 150 mg Janssen Cilag SpA ITALY 173 TZ 14 H 0270 Edur ant Rilpi virine hydrochloride Tablets 25 mg Janssen Cilag SpA ITALY Registrant: Johnson & Johnson (PTY) Limited, SOUTH AFRICA 174 TAN 00 ,122 Nizoral Ketoconazole Solution

2.10 % D01 A JAN Janssen Pharm aceutica N.V BELGIUM Registrant: JOHNSON AND JOHNSON (PTY) LTD, SOUTH AFRICA 175 TAN 00 ,128 Verm ox Mebendazole Tablets 100 mg P02X JAN Registrant: Johnson and Johnson Proprietary Limited, UNITED KINGDOM 176 TAN 00 ,126 Verm ox Mebendazole P02X JAN Suspension, Oral 20 mg/ ml 177 TAN 00 ,127 Verm ox Mebendazole Tablets 500 mg P02X JAN BELGIUM JANSSEN CILAG INTERNATION AL NV BELGIUM BELGIUM JANSSEN CILAG INTERNATION AL NV JANSSEN CILAG INTERNATION AL NV Registrant: Kremoint Pharma Pvt. Ltd, INDIA 178 TZ 19 H 0341 Fungoal Cream Clobetasol Cream

1.00 %w/ w Kremoint Pharm a Pvt. Ltd INDIA Registrant: Kusum Healthcare Private Limited, INDIA 179 TZ 19 H 0245 MEZACAR Carbamazepine Tablet, Film-coated 200 mg 180 TZ 19 H 0244 GABAFAST Gabapent in Capsules 300 mg 181 TZ 19 H 0405 Candigo Clotr imazole Suppositori es 500 mg 182 TZ 19 H 0349 Bactopic Ointm ent Mupirocin Ointm ent 2/ 20 mg Registrant: Kusum Healthcare Private Limited, INDIA Kusum Health care Private Limited Kusum Health care Private Limited Kusum Health care Private Limited Kusum Health care Private Limited INDIA INDIA INDIA INDIA 16 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 183 TZ 19 H 0290 Orgyl Orn idazole Tablets 500 mg Registrant: Laboratories and Allied Limited, KENYA 184 TAN 00 ,1867 Labesten Clotr imazole Cream 1 %w/ w D01 A LAA Kusum Health care Private Limited INDIA Laboratories and Alli ed Limited KENYA 185 TAN 00 ,1989 Gifol R03 A LAA Ephedrine + Theophylli ne Tablets 11 mg + 120 mg Laboratories KENYA 186 TAN 00 ,1988 P02X LAA Natoa Mebendazole Tablets 100 mg Registrant: Laurus Labs Limited, 187 TZ 19 H 0228 Dolutegravir Tablets 50 mg Dolutegravir Sodium Tablet, Film- coated 50 mg 188 TZ 19 H 0289 Emtr icitabine and Tenofovir Disoproxil Fum arate tablets 189 TZ 19 H 0225 DARUNAVIR TABLETS 800 MG Emtr icitabine and Tenofovir Disoproxil Fum arate Darun avir Registrant: Laurus Labs Limited., INDIA 190 TZ 19 H 0224 DARUNAVIR TABLETS 400 MG Darun avir 191 TZ 19 H 0223 DARUNAVIR TABLETS 600 MG Darun avir Registrant: Lincoln Pharmaceuticals Limited, INDIA Tablet, Film- coated 200 / 300 mg Tablet, Film- coated 800 mg Film Coated Tablet 400 mg Film Coated Tablet 600 mg and Alli ed Limited Laboratories and Alli ed Limited KENYA INDIA INDIA INDIA INDIA INDIA LAURUS LABS LIMITED (UNIT-II) LAURUS LABS LIMITED (UNIT-II) LAURUS LABS LIMITED (UNIT-II) LAURUS LABS LIMITED (UNIT-II) LAURUS LABS LIMITED (UNIT-II) 192 TAN 09 ,285 Aminophylli ne Aminophylli ne Solution R03 A LIN 193 TZ 19 H 0322 CARVILIN 6.25 Carvedil ol Tablets 25 mg/ ml Lincoln Parent eral Limited

6.25 mg/ tablet Lincoln INDIA INDIA 194 TZ 19 H 0314 HISTALIN-8 Betahistine Dihydrochloride Tablets 8 mg 195 TZ 19 H 0202 BUPILIN HEAVY Bupivacaine Hydrochloride Solution for injection 5 mg/ ml 196 TAN 00 ,1991 Vivian Diclofenac Tablets M01 A LIN 1 % w/ w + 10 % w/ w + 5 %w/ w + 3 %w/ w Pharm aceuticals Limited Lincoln Pharm aceuticals Limited Lincoln Parent eral Limited Lincoln Pharm aceuticals Limited INDIA INDIA INDIA 17 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 197 TAN 09 ,157 Dolomol paracetamol Tablets 500 mg N02B LIN 198 TZ 19 H 0269 CAPRIL - 25 Captopril Tablets 25 mg/ tablet INDIA INDIA Lincoln Pharm aceuticals Limited Lincoln Pharm aceuticals Limited 199 TAN 00 ,1993 J 01 F LIN L Gent a Gent amycin Solution for injection 80 mg/ 2ml Lincoln Parent eral Limited INDIA 200 TZ 19 H 0293 HISTALIN-16 Betahistine Dihydrochloride Tablets 16 mg INDIA Lincoln Pharm aceuticals Limited Registrant: Macleods Pharmaceuticals Limited, INDIA 204 TZ 14 H 0316 Lamivudine Tenofovir and Lamivudine Tablets Registrant: Macarthys Laboratories Limited T/ A Martindale Pharmaceuticals, UNITED KINGDOM 203 TZ 19 H 0203 Glycopyrr Glycopyrr onium bromide Solution for injection Registrant: Lupin Limited, INDIA 201 TZ 19 H 0351 Rifampicin 150 mg + Isoniazid 75 mg 202 TZ 19 H 0350 Rifampicin 150 mg + Isoniazid 75 mg + Eth ambutol 275 mg + Pyrazin amide 400 mg onium Bromide 300 mg & Tenofovir Disoproxil Fum arate 300 mg Fluocinonide Topical Solution USP

0.05 % 205 TZ 19 H 0406 206 TZ 19 H 0297 Rifampicin and Isoniazid tablets 207 TZ 19 H 0242 Triolmesar 208 TZ 19 H 0241 Triolmesar fort e 5 209 TZ 19 H 0368 RH Com Rifampicin + Isoniazid Rifampin + Isoniazid + Pyrazinamide + Eth ambutol Tablets 150 + 75 mg Lupin Limited INDIA Tablets 150 + 275 + 400 mg Lupin Limited INDIA UNITED KINGDOM 200 mcg/ ml Macarth ys Laboratori es Limited T/ A Mart indale Pharm aceuticals 300 mg + 300 mg Macleods Pharm aceuticals Limited INDIA Fluocinonide Topical Solution

0.05 / 0.5 mg OXALIS LABS INDIA Rifampicin + Isoniazid Tablet, Dispersibl e 75 + 50 mg Olmesart an + Amlodipi ne + Hydrochl Olmesart oroth an + iazide Amlodipi ne + Hydrochl Rifampicin and oroth Isoniazid iazide Tablet, Film- coated 20 + 12 .5 + 5 mg Tablet, Film- coated 40 + 12 .5 + 5 mg Tablet, Film- coated 150 + 75 mg Macleods Pharm aceuticals Limited Macleods Pharm aceuticals Limited Macleods Pharm aceuticals Limited Macleods Pharm aceuticals Limited INDIA INDIA INDIA INDIA 18 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 210 TZ 14 H 0228 Olmesar H Tablets 20 mg + 12 .5mg Olmesart an Medoxomil & Hydrochlorot h iazide 211 TZ 19 H 0332 Zadiw ays - 500 Azithr omycin Registrant: Mankind Pharma Limited, INDIA 500 mg Tablets Dihydrate INDIA INDIA Macleods Pharm aceuticals Limited Man Kind Pharm a Limited Registrant: MEDLEY PHARMACEUTICALS LIMITED, INDIA 212 TAN 09 ,174 J 01K MED Ecoflox 500 Ciprofloxacin Tablets 500 mg 213 TAN 00 ,2010 A07D MDC Vacont il Registrant: Medochemie Limited, CYPRUS 2 mg Loperamide Capsules 214 TAN 00 ,4564 J 01 F MED 215 TAN 09 ,175 J 01H MED Registrant: Medopharm, INDIA Erythr omycin Stearate Amoxicilli n Erythr omycin Amoxicilli n Tablet, Film- coated Capsules 250 mg 250 mg 216 TZ 14 H 0259 Phenoxymeth ylpenicilli n Phenoxymeth yl Penicilli n Tablets 250 mg 217 TZ 14 H 0233 Medomox 125 Amoxicilli n DT Tablet, Dispersibl e 125 mg Registrant: Medopharm Private Limited, INDIA 218 TZ 14 H 0273 Ilaxten Tablets 20 mg Registrant: Menarini International Operations, INDIA 219 TZ 14 H 0216 bifril Zofenopril Tablets 30 mg 220 TZ 14 H 0323 Spasmomen Otili um Bromide Tablets 40 mg Medley Pharm aceuticals Limited INDIA Medochemie Limited CYPRUS INDIA INDIA INDIA INDIA ITALY ITALY ITALY Medopharm Medopharm Private Limited Medopharm Private Limited Medopharm Private Limited A.Menarini Manufactur ing Logistic and Services S.r.l A.Menarini Manufactur ing Logistics and Services A.Menarini Manufactur ing Logistic and Services S.r.l 221 TZ 19 H 0199 TACEEDO-120 Docetaxel Injection 120 / 3 mg/ ml MIRACALUS INDIA Registrant: MIRACALUS PHARMA PVT LTD, INDIA 222 TZ 19 H 0197 ZILDOX 50 Oxalipl atin Lyophili zed Injection 50 mg PHARMA PVT. LTD. MIRACALUS PHARMA PVT LTD INDIA 19 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: Moraf Pharmaceuticals LTD, Tanzania 223 TZ 19 H 0187 GABAPEN 300 Gabapent in Capsules, hard 300 mg THE MADRAS PHARMACEUT ICALS INDIA Registrant: MSN LABORATORIES PRIVATE LIMITED, INDIA 224 TZ 19 H 0391 Bosent an Tablets PULMOFIRST

62 .5 mg 225 TZ 19 H 0392 PULMOFIRST 125 Bosent an Tablets Tablet, Film-coated 125 mg Registrant: MSN Laboratories Private Limited , INDIA 226 TZ 14 H 0218 Nebiem 5 Nebivolol Hydrochloride Tablets 5mg 227 TZ 14 H 0213 Nebiem 2.5 Nebivolol Hydrochloride Tablets

2.5mg 228 TZ 14 H 0194 Nebiem 10 Nebivolol Hydrochloride Tablets 10 mg INDIA INDIA INDIA INDIA INDIA MSN Laboratories Private Limited (Formu lations Division), MSN Laboratories Private Limited (Formu lations Division), MSN LABORATORIE S PRIVATE LIMITED (Formu lation Division) MSN LABORATORIE S PRIVATE LIMITED (Formu lation Division) MSN LABORATORIE S PRIVATE LIMITED (Formu lation Division) Registrant: MSN LABORATORIES PRIVATE LIMITED, INDIA 229 TZ 19 H 0385 Rosuvastatin LDNIL 5 Tablet, Film-coated 5 mg MSN Laboratories Private Limited INDIA Registrant: Mundipharma Pty Limited, AUSTRALIA 230 TZ 19 H 0273 Onicit Palonosetr on Solution for injection

0.075 / 1.5 mg/ ml Helsinn Birex Pharm aceuticals Limited IRELAND Registrant: Mylan Laboratories Limited, INDIA 231 TZ 19 H 0282 Abaganil 75 Pregabalin Capsules 75 mg 232 TZ 19 H 0191 MyHep ALL Sofosbuvir 400 / 100 mg Film Coated Tablet 20 Mylan Laboratories Limited Mylan Laboratories LIMITED INDIA INDIA Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 233 TZ 19 H 0283 ABAGANIL 150 Pregabalin Capsules 150 mg Mylan Laboratories Limited INDIA Registrant: Mylan Pharmaceutical Private Limited, INDIA 234 TZ 19 H 0323 FULPHILA Pegfilgrastim Solution for injection 6 mg Biocon Limited INDIA Registrant: Mylan Pharmaceuticals Private Limited, INDIA 235 TZ 19 H 0220 ETULOX 30 Etoricoxib Film Coated Tablet 30 mg 236 TZ 19 H 0219 ETULOX 120 Etoricoxib Film Coated Tablet 120 mg 237 TZ 19 H 0207 Cardisar HT 80 /

12 .5 Valsart an + Hydrochloroth iazide Tablets 80 + 12 .5 mg 238 TZ 19 H 0206 Cardisar HT 160 / 25 Valsart an + Hydrochloroth iazide Tablets 160 + 25 mg 239 TZ 19 H 0189 Endulin VIAL 240 TZ 19 H 0205 Cardisar HT 160 / 12 .5 Insulin Glardine (r DNA Origin) 100 IU/ ml Valsart an + Injection Hydrochloroth iazide Solution for injection 100 IU/ ml Tablets 160 + 12 .5 mg AIZANT INDIA Registrant: Napp Pharmaceuticals limited, UNITED KINGDOM 241 TZ 19 H 0285 Oxynorm Oxycodone Solution for injection 10 mg/ ml Registrant: Natco Pharma Limited., INDIA 242 TZ 19 H 0234 HEPCINAT Sofosbuvir Tablets 400 mg Natco Pharm a Limited. INDIA Registrant: Nectar Lifesciences Limited, INDIA 243 TZ 19 H 0329 FIXINECT 200 Cefixi me 200 Tablets 400 mg INDIA Nectar Lifesciences Limited - UNIT VI Registrant: Neopharma, UNITED ARAB EMIRATES 21 Fourr ts (India) Laboratories Private Limited Fourr ts (India) Laboratories Private Limited AIZANT DRUG RESEARCH SOLUTIONS PVT. AIZANT LIMITED DRUG RESEARCH SOLUTIONS PVT. LIMITED BIOCON LIMITED INDIA INDIA INDIA INDIA INDIA DRUG RESEARCH SOLUTIONS PVT. LIMITED B.BRAUN MELSUN GEN AG GERMANY Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 244 TZ 14 H 0256 Resclar Clarithr omycin Tablets 500 mg Neopharm a 245 TZ 19 H 0318 NEOMOL CF 246 TZ 19 H 0317 NEOMET Paracetamol + Chlorphenamin e Maleate + Pseudoephedrin e Hydrochloride Metform in Hydrochloride Tablets 500 / 30 / 2 mg Neopharm a Tablets 500 mg Neopharm a 247 TZ 19 H 0384 NEOMET Metform in Tablets 1000 mg Neopharm a UNITED ARAB EMIRATES UNITED ARAB EMIRATES UNITED ARAB EMIRATES UNITED ARAB EMIRATES Registrant: North China Pharmaceutical Co.Limited, CHINA 248 TZ 19 H 0295 AUKETAB Registrant: Novo Nordisk A/ S, GREECE 249 TAN 00 ,221 A01 A NOV Insulatard Amo xicill i n tr ihydr ate & Potas sium Clav ulan Insulin ate Tablets 500 / 125 mg North China Pharm aceutical Co., Limited CHINA Liquid 100 IU Novo Nordisk A/ S DENMARK 250 251 TAN 00 ,224 A01 A NOV TAN 00 ,220 A01 A NOV ACTRAPID Hum an Insulin Injection 100 IU/ ml Novo Nordisk A/ S DENMARK Mixtard Insulin Injection 70 IU + 30 IU Novo Nordisk DENMARK A/ S Registrant: NVS Kenya Limited, KENYA 252 TZ 14 H 0291 253 TZ 14 H 0298 Lamisil Terbinafine Tablets 125 mg Lamisil 250 mg Terbinafine Tablets 250 mg Registrant: Nycomed (Pty) Limited, SOUTH AFRICA 254 TZ 19 H 0249 Pant oloc 20 Pant oprazole Tablets Registrant: Oman Pharmaceutical Products Co., LLC, SULTANATE OF OMAN 255 TZ 19 H 0401 Cefovex 500 Cefur oxime Axetil Tablets 500 mg NOVARTIS FARMACEUTIC ALS S.A NOVARTIS FARMACEUTIC ALS S.A SPAIN SPAIN NYCOMED ORANIENBURG Gmm bH GERMANY Oman Pharm aceutical Products Co., LLC SULTAN ATE OF OMAN 22 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: Otsuka Pharmaceutical India Private Limited, INDIA 256 TAN 05 ,069 P01 Metr is Metr onidazole Injection

0.5% w/ v A CLA Registrant: Pfizer Laboratories Limited, KENYA 257 TZ 19 H 0383 ZAVICEFTA 2g/

0.5g Ceftazidi me/ avibactam Solution for injection 2 g Otsuk a Pharm aceutical India Private Limited INDIA ITALY GLAXOSMITH KLINE MANUFACTUR ING S.P.A 258 TZ 19 H 0311 Pharm oru bicin Epiru bicin Hydrochloride Solution for injection 2 mg/ ml Pfizer (Perth ) Pty Limited AUSTRAL IA Registrant: PharmactiveIlac San.ve Tic.A.S/ Tekirdag, TURKEY 259 TZ 19 H 0250 Myesed Tadalafil Tablet, Film- coated 20 mg Pharm activeIlac San.ve Tic.A.S/ Tekirdag TURKEY Registrant: Pharmathen S.A., GREECE 260 TZ 19 H 0382 Meperya Meropenem Trihydrate 1 g Powder for solution for injection Pharm ath en S.A. GREECE Registrant: Phillips Pharmaceuticicals Tanzania Limited, Tanzania 261 TZ 19 H 0188 KLACID IV Clarithr omycin 500 mg Powder for solution for injection Famar L'Aigle Usine St Remy FRANCE Registrant: Piramal Enterprises Limited, 262 TAN 00 ,4568 N01 A NIC Haloth ane Haloth ane Liquid 250 ml Piramal Ent erprises Limited INDIA Registrant: PRINCE PHARMACEUTICALS CO. LTD, Tanzania 263 TZ 19 H 0222 Asth amol Salbutamol Sulphate Syru p 2/ 5 mg/ ml Registrant: Prince Pharmaceuticals Company Limited, Tanzania 264 TZ 15 H 0017 Whitfield's Ointm ent Benzoic Acid and Salicylic Acid Ointm ent 6+3 %w/ v Tanzania Prince Pharm aceuticals Company Limited Tanzania Prince Pharm aceuticals Company Limited 265 TZ 15 H 0015 Dawa ya Mba (Ant i - fungal lotion) Benzoic Acid + Salicylic Acid Solution 6%w/ v + 3%w/ v Prince Pharm Tanzania aceuticals Company Limited 23 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 266 TZ 15 H 0014 Calamine Lotion Calamine Lotion 15 %w/ v + 5%w/ v PRINCE PHARMACEUT ICALS CO.LTD Tanzania Registrant: Prisma Pharmaceuticals Limited, UNITED KINGDOM 267 TAN 09 ,290 Flora Norm Soybean oil Emu lsion 250 mg V03 A PRI Registrant: Reckitt Benckiser Healthcare UK Limited, UNITED KINGDOM INDIA BHARAT BIOTECH INTERNATION AL LIMITED. 268 TZ 19 H 0320 269 TZ 19 H 0301 270 TZ 19 H 0300 Gaviscon Double Action Tablets Gaviscon Liquid Sachets Gaviscon Double Action Liquid Sodium Alginate+Sodium Bicarbonate+Calciu m Carbonate Sodium Alginate+Sodium Bicarbonate+Calciu m Carbonate sodium alginate + sodium bicarbo nate Registrant: Regal Pharmaceuticals Limited, KENYA Tablets 250 ,106 .5,187 .5 mg Reckitt Benckiser Health care (UK)Limited. Suspension, Oral Suspension, Oral 500 ,267 ,160 mg Reckitt Benckiser Health care (UK)Limited. 500 ,213 ,325 mg Reckitt Benckiser Health care (UK)Limited. UNITED KINGDO M UNITED KINGDO M UNITED KINGDO M 271 TAN 00 ,1483 J 03B REG Unitr im Sulfameth oxazole+Trimeth oprim Suspension, Oral 200 mg/ 5ml + 40 mg/ 5ml 272 TAN 00 ,1184 Rinalin Chlorpheniramine Syru p 2 mg/ 5ml V03 A REG Registrant: Remedica Limited, CYPRUS 273 TAN 00 ,4624 Alfoxan Mefenamic Acid Capsules 250 mg M01 A REM 274 TAN 00 ,2030 Roxitan Piroxicam Capsules 20 mg M01 A REM 275 TAN 00 ,4626 P01 A REM Tinirem Tinidazole Tablets 500 mg 276 TAN 00 ,4625 Priaxen Naproxen Tablets 500 mg M01 A REM Registrant: S K Age Exports, INDIA Regal Pharm aceuticals Limited Regal Pharm aceuticals Limited KENYA KENYA Remedica Limited Remedica Limited Remedica Limited Remedica Limited CYPRUS CYPRUS CYPRUS CYPRUS 277 TZ 19 H 0399 CALYZID Calcium Carbonate Powder Suspension, Oral 625 mg S Kant Health care Limited INDIA 278 TAN 09 ,223 P01B SK Quinine Sulphate Quinine Sulphate Tablets 300 mg 279 TZ 19 H 0267 M - Dopakant - Meth yldopa Tablets 250 mg 250 S Kant Health care Limited INDIA S Kant Health care Limited INDIA Registrant: Salama Pharmaceuticals Limited, Tanzania 24 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 280 TZ 14 H 0293 Alphaclox 500 Ampicilli n and enzyme inh ibi tor

0.25 g + 0.25 g Powder for solution for injection 281 TZ 19 H 0304 Cerox Cefur oxime Sodium Injection 1500 mg 282 TZ 19 H 0243 Allerieve 10 Cetirizine hydrochloride Tablets 10 mg 283 TZ 19 H 0303 Cefitax Cefixi me Trihydrate Suspension, 50 mg/ 5 ml Oral CHINA INDIA INDIA INDIA CSPC Zhongnuo Pharm aceutical (Shiji azhuang) Co. Ltd Scott Edil Advanced Research Laboratories & Education Limited ACME FORMULATI ON PRIVATE LIMITED Scott Edil Advanced Research Laboratories & Education Limited 284 TZ 19 H 0248 Art esunate Art esunate Suppositori es 100 mg Cipl a Limited INDIA Registrant: Sance Laboratories Private Limited, INDIA 285 TZ 19 H 0186 Sanaxone Plus - 1000 286 TZ 14 H 0195 Sanceph - DS 250 287 TZ 14 H 0306 Sandrox - DS 125 Ceftr iaxon e Sodiu m and Cephalexin Sulba ctam Sodiu m Cefadroxil 1000 mg Powder for solution for injection Sance Laboratories Private Ltd INDIA 250 mg/ 5ml Powder for Oral suspension 125 mg/ 5ml Powder for Oral suspension INDIA INDIA Sance Laboratories Private Limited Sance Laboratories Private Limited 25 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 288 TZ 14 H 0277 Sandrox 500 Cefadroxil Capsules 500 mg INDIA Sance Laboratories Private Limited Registrant: Sanofi Aventis Kenya Limited, KENYA 289 TZ 14 H 0274 Rhinath iol 5% Syru p Carbocisteine Syru p 5% A.Natt erm an & Cie. GmbH GERMANY 290 TAN 00 ,4584 J 07 A AVE 291 TAN 00 ,4586 B01 A AVE Verorab Rabies Viru s Powder 23 IU Clexane Enoxaparin Solution for injection 60 mg/ 0.6 ml Sanofi Pasteur S.A. sanofi Wintr op Industr ie FRANCE FRANCE 292 TAN 09 ,202 P01B SAN Art esunate/ Amodiaquine Winthr op Art esunate + Amodiaquine Tablets 50 mg + 135 mg Maphar MOROCCO Laboratories 293 TAN 00 ,4585 Clexane Enoxaparin B01 A AVE Solution for injection FRANCE SANOFI WINTHROP INDUSTRIE MAISONS- ALFORT,FRANCE 26 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 294 TAN 09 ,097 J 01D AVE Orelox Cefpodoxime Tablets 100 mg 295 TZ 14 H 0263 Rhinath iol Carbocisteine Syru p 2% Sanofi Winthr op Industr ie FRANCE A.Natt erm an & Cie. GmbH GERMAN Y Registrant: SANZYME (P) Limited., INDIA 296 TZ 19 H 0198 GYNOGEN HP 75 IU Hum an menopausal gonadotr opin (HMG) or Menotr ophin 75IU Lyophili zed Injection 75 IU/ vial SANZYME (P) Limited. INDIA Registrant: Schering Plough Proprietary Limited, SOUTH AFRICA 297 TAN 05 ,080 R06 A SCH Aerius Oral Solution Desloratadine Solution 05 mg/ ml Schering Plough Laboratories N.V BELGIUM Registrant: Serum Institute of India Private Limited, INDIA 298 TZ 19 H 0280 Rabishield - 100 Rabies Registrant: Shanghai Fosun Pharmaceutical Development Ltd, CHINA Solution for injection 40 IU/ ml Serum Institute of India Private Limited INDIA Hum an Monoclo nal Ant ibody 299 TZ 14 H 0310 D- ARTEPP Dihydroart emisinin and Piperaquine Tablets 40 mg/ 320 mg Registrant: Shelys Pharmaceuticals Limited, Tanzania 300 TZ 19 H 0212 Tenbloka- 50 Atenolol Tablets 50 mg 301 TAN 09 ,216 J 01K SHE 302 TAN 09 ,211 M01 A SHE Levoz Levofloxacin Tablets 500 mg Acefen aceclofenac Tablets 100 mg 303 TZ 19 H 0373 Koflyn Raspberr y® Dip henh ydramine Hydrochloride Solution, Oral 14 mg/ 5ml 304 TAN 09 ,214 Maladar Kit P01B SHE Art esunate + Amodiaquine Tablets CHINA GUILI N PHARMACEUT ICAL COMPANY Limited Shelys Pharm aceuticals Limited Shelys Pharm aceuticals Limited Shelys Pharm aceuticals Limited Shelys Pharm aceuticals Limited Shelys Pharm aceuticals Limited Tanzania Tanzania Tanzania Tanzania Tanzania 305 TZ 19 H 0235 Septr in DS Sulfameth oxazole & Trimeth oprim Tablets 800 + 160 mg GlaxoSmith Kline S.A.E EGYPT 306 TAN 09 ,217 R06 Sheltr izine A SHE Cetirizine hydrochloride Tablets 10 mg Shelys Pharm aceuticals Limited Tanzania 27 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 307 TAN 09 ,222 J 03 Nor - T C SHE Norfloxacin + Tinidazole Tablets 500 mg + 400 mg 308 TAN 09 ,220 M01 A SHE Diclopar - MR 309 TAN 09 ,219 Worm azole P01 A SHE Diclofec Sodium BP + Paracetamol BP + Chlorzoxazine USP Tinidazole Tablets 50 mg + 500 mg + 250 mg Tablets 500 mg 310 TZ11H047 Praziquant el Praziquant el Tablets 600 mg Tanzania Tanzania Tanzania Tanzania Shelys Pharm aceuticals Limited Shelys Pharm aceuticals Limited Shelys Pharm aceuticals Limited Shelys Pharm aceuticals Limited Registrant: Shin Poong Pharma Co. Ltd, KOREA 311 TZ 19 H 0375 Varodipi ne Amlodipi ne Besilate Tablets 5 mg Shin Poong Pharm . Co. Ltd KOREA Registrant: Skant Health care Limited, INDIA 312 TZ 19 H 0347 MALAKANT Sulfadoxine + Pyrimeth amine Tablet, Dispersibl e 500 / 25 mg S Kant Health care Ltd. INDIA 313 TZ 19 H 0346 MALAKANT JUNIOR DISPERSIBLE Sulfadoxine & Pyrimeth amine Tablets 250 / 12 .5 mg S Kant Health care Ltd. INDIA Registrant: South Egypt Drug Industries Company, EGYPT 314 TZ 19 H 0307 Magna-bi otic Amoxicilli n + Clavulanic acid Powder for solution for injection 500 + 100 mg/ vial EGYPT South Egypt Dru gs Industr ies Co. (SEDICO) Registrant: Sparsh Bio-tech Private Limited, INDIA 315 TZ 19 H 0296 Co-Fluampicil Flucloxacilli n + Ampicilli n Capsules Y.S.P Industr ies (M) SDN. BHD MALAYSI A Fluclox acilli n 250 mg+ Ampicil li n 250 mg mg Registrant: Square Pharmaceuticals Limited, Bangladesh 316 TZ 19 H 0294 anadol Tramadol Capsules 50 mg 317 TZ 14 H 0319 Zimax 500 Azithr omycin Dihydrate Tablets 500 mg SQUARE PHARMACE UTICALS LIMITED SQUARE PHARMACE UTICALS LIMITED Banglades h Banglades h 28 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 318 TZ 14 H 0185 Maxpi Cefepime me 1gm IM/ IV Inject ion 319 TZ 19 H 0365 Square zinc 1gm Powder for solution for injection Zinc Sulphate Monohydrate Tablet, Dispersibl e 20 mg 320 TZ 19 H 0316 Mucospel Bromh exine Hydrochloride Syru p 4 mg/ 5ml Registrant: SRS Life Sciences Pvt Ltd, Singapore 321 TZ 19 H 0291 RABEMAC Rabeprazole Injection 20 mg Registrant: Steril-Gene Life Sciences Private Limited, INDIA 322 TZ 19 H 0309 PUFRAN Ondansetr on Injection 2 mg Registrant: Steril-Gene Lifesciences Pvt.Ltd, INDIA 323 TZ 19 H 0275 PEPCINON Oxytocin Injection 10 IU/ ml SQUARE PHARMACEUT ICALS LIMITED SQUARE PHARMACEUT ICALS LIMITED Square Pharm aceuticals Limited Bangladesh Bangladesh Bangladesh Imm acule Lifesciences Private Limited INDIA STERIL- GENE LIFE SCIENCES (P) LTD INDIA Steril- Gene Life Sciences Private Limited INDIA Registrant: Sun Pharmaceutical Industries Limited, INDIA 324 TAN 00 ,4623 J 01K RAN Cifran CT Ciprofloxacin + Tinidazole Tablets 325 TAN 09 ,328 A10B SUN Glucored Fort e Glib enclamide + Tablets Metform in 500 mg + 600 mg SUN PHARMACEUT IAL INDUSTIRES LIMITED 5 mg + 500 mg Sun Pharm 326 TAN 09 ,230 Irovel H C01 L SUN Irbesart an + Hydrochloroth iazide Tablets 150 mg + 125 mg INDIA INDIA INDIA aceutical Industr ies Limited Sun Pharm aceutical Industr ies Limited Registrant: Sunberg Life Science Private Limited, INDIA 327 TZ 19 H 0211 H- ZIDE Hydrochloroth iazide Tablets 25 mg 328 TZ 19 H 0331 Rosuvan 10 Rosuvastatin Tablets 10 mg 329 TZ 19 H 0313 PREGABA 150 Pregabalin Capsules 150 mg THE MADRAS PHARMACEUT ICALS THE MADRAS PHARMACEUT ICALS INDIA INDIA THE MADRAS PHARMACEUTI CALS INDIA 29 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: Surge Laboratories Private Limited, PAKISTAN 330 TZ 19 H 0403 Bacip 200 mg/ 100 ml Infusion Ciprofloxacin Lactate USP Registrant: T-MARC TANZANIA, Tanzania Solution for injection 200 / 100 mg/ ml Sur ge PAKISTAN Laboratories (PVT) Limited 331 TZ 19 H 0254 Flexi P Levonorgestr el, Eth inylestr adiol, Ferr ous Fum arate Tablet, coated

0.15 / 0.03 / 75 mg Mylan Laboratories Limited INDIA Registrant: Takeda Pharma A/ S, DENMARK 332 TZ 19 H 0210 Ninlaro Ixazomib Tablets 3 mg 333 TZ 19 H 0209 NINLARO Ixazomib Tablets 4 mg 334 TZ 19 H 0208 NINLARO Ixazomib Tablets

2.3 mg Registrant: Takeda Proprietary Limited, SOUTH AFRICA 335 TZ 14 H 0184 Pant oloc IV Pant oprazole Injection 40 mg Registrant: Torrent Pharmaceuticals Limited, INDIA 336 TZ 19 H 0185 ROSUCOR 20 Rosuvastatin Calcium Film Coated Tablet 20 mg 337 TZ 19 H 0184 ROSUCOR 10 Rosuvastatin Calcium Film Coated Tablet 10 mg Registrant: Torrent Pharmaceuticals Ltd.., INDIA 338 TZ 19 H 0252 Itr azole Itr aconazole Capsules, hard 100 mg Registrant: Unichem Laboratories Limited, INDIA 339 TZ 14 H 0207 Ramiz 5 Ramipril Tablets 5mg 30 Haupt Pharm a Amareg GmbH Haupt Pharm a Amareg GmbH Haupt Pharm a Amareg GmbH GERM ANY GERM ANY GERM ANY Takeda GmbH GERM ANY INDIA INDIA INDIA TORRENT PHARMACE UTICALS LIMITED (TPL) TORRENT PHARMACE UTICALS LIMITED (TPL) TORRENT PHARMACE UTICALS LIMITED (TPL) Unichem Laboratories Limited INDIA Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 340 TZ 14 H 0244 Ramiz 2.5 Ramipril Tablets

2.5 mg 341 TAN 00 ,909 J 01H UNI Ampoxin 500 Ampicilli n + Cloxacilli n Powder 250 mg + 250 mg 342 TAN 00 ,2063 J 01K UNI Evaflox 200 ofloxacin Tablets 200 mg 343 TAN 00 ,4577 J 01 C UNI Myclav 375 Amoxicilli n + Clavulanate Tablets 250 mg + 125 mg Unichem Laboratories Limited Unichem Laboratories Limited - Baddi Unit I Unichem Laboratories Limited Unichem Laboratories Limited - Baddi Unit I Registrant: Unique Pharmaceutical Laboratories (A division of J.B. Chemicals & Pharmaceuticals Ltd), INDIA 344 TAN 00 ,305 M01 A UNI Dicloran Diclofenac Gel 1 % w/ w + 10 %w/ w + 3 %w/ w + 5 %w/ w 345 TAN 00 ,404 Ecodax G D07 X UNI Cream Beclometh asone + Econazole + Gent amycin 346 TZ 14 H 0265 Ifimol I.V paracetamol 10 mg/ ml Solution for injection Registrant: United Pharmaceutical Mfg. Co. Limited, JORDAN 347 TZ 19 H 0378 NEO-GABA 75 Pregabalin Capsules 75 mg Capsules, hard 75 mg Registrant: United Pharmaceuticals Manufacturing Limited Company, JORDAN 348 TZ 19 H 0306 Senergy Amlodipi ne + Valsart an Tablets 10 + 160 mg 349 TZ 19 H 0305 Senergy Amlodipi ne + Valsart an Tablets 5 + 160 mg Unique Pharm aceutical Laboratories (A division of J.B Chemicals Unique & Pharm aceuticals Pharm Ltd) aceutical Laboratories (A division of J.B Chemicals Unique & Pharm aceuticals Pharm Ltd) aceutical Laboratories (A Division of J.B Chemicals and Pharm aceuticals United Pharm Limited) aceutical Mfg. Co. Limited United Pharm aceuticals Manufactur ing Limited Company United Pharm aceuticals Manufactur ing Limited Company INDIA INDIA INDIA INDIA INDIA INDIA INDIA JORDAN JORDAN JORDAN 31 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 350 TZ 19 H 0192 Anatax Betahistine Tablets 16 mg 351 TZ 19 H 0308 Scolta Rosuvastatin Calcium Tablets 40 mg 352 TZ 19 H 0196 Unifed Syru p Syru p (1.25 +30 ) mg/ 5ml Triproline + Pseudoephe drine Hydrochlori de+Codeine Registrant: Universal Corporation Limited, KENYA 353 TZ 14 H 0280 Altr ine Cetirizine Tablets 10 mg Registrant: Unosource Pharma Limited, INDIA 354 TZ 19 H 0298 Plenm oxi Moxifl oxacin Hydrochloride Solution

0.5 w/ v 355 TZ 19 H 0264 Therm odol - 150 paracetamol 300 mg/ 2ml Solution for injection 356 TZ 19 H 0319 UNOSURE 72 Levonegestr el Tablet, coated 1.5 mg Registrant: Velve Human Care laboratories, INDIA 357 TZ 19 H 0333 Verbital Phenobarbital Sodium BP Solution for injection 100 mg/ ml Registrant: VENUS REMEDIES LIMITED, INDIA 358 TZ 14 H 0311 Ronem Meropenem Injection 1000 mg JORDAN JORDAN JORDAN United Pharm aceuticals Manufactur ing Limited Company United Pharm aceutical Mfg. Co. Limited United Pharm aceuticals Manufactur ing Limited Company Universal Corporation Limited KENYA INDIA INDIA INDIA Akum s Dru gs and Pharamceutic al Limited Akum s dru gs and Pharm aceutical Limited AKUMS DRUGS AND PHARMACE UTICALS LIMITED Verve Hum an Care Laboratories INDIA Venus Remedies LIMITED Registrant: Venus Remedies Limited, INDIA 359 TZ 19 H 0369 Robol Doxoru bicin Hydrochloride Solution for injection 50 / 25 mg/ ml Venus Remedies Limited INDIA Registrant: VENUS REMEDIES LIMITED, INDIA 32 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 360 TZ 14 H 0192 Elores 1.5 g Ceftr iaxone/ combinations 1000 mg + 500 mg Venus Remedies LIMITED Powder and solvent for solution for injection Registrant: Venus Remedies Limited, INDIA 361 TZ 19 H 0342 Citabol Gemcitabine 1000 mg Powder and solvent for solution for infusion VENUS REMEDIES LIMITED INDIA Registrant: VERVE HUMAN CARE LABORATORIES, INDIA 362 TZ 19 H 0335 Verbital-30 363 TZ 19 H 0334 Verbital-100 Phenobarbital Sodium BP Phenobarbital Sodium BP Tablets 30 mg Tablets 100 mg Verve Hum an Care Laboratories Verve Hum an Care Laboratories INDIA INDIA Registrant: VHB MEDI SCIENCES LIMITED, INDIA 364 TZ 19 H 0218 THIOTEC Thiopent al 365 TZ 19 H 0232 Platifirst Cisplatin Registrant: VHB Medisciences Limited, INDIA Solution for injection 500 mg Solution for injection 1 mg/ ml VHB MEDI SCIENCES LIMITED VHB MEDI SCIENCES LIMITED INDIA INDIA 366 TZ 14 H 0258 Succicort 100 Hydrocort isone Injection 100 mg/ vial mg VHB MEDI SCIENCES LIMITED INDIA Registrant: Virchow Healthcare Private Limited, INDIA 367 TZ 19 H 0330 Debridace Papain USP and Urea USP Ointm ent ?521700 +100 Virchow Biotech Pvt Ltd INDIA 368 TZ 19 H 0388 Clasipro Bacill us clausii Suspension, Oral Virchow Biotech Pvt Ltd INDIA 369 TZ 19 H 0353 OSTEOTIDE Teriparatide Recombinant Hum an Parath yroid Horm one Injection 250 mcg/ ml VIRCHOW BIOTECH PVT LTD. INDIA Registrant: Wockhardt Limited, INDIA 33 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 370 TZ 14 H 0296 Glaritus insulin glargine Solution for injection 100 IU/ ml Wockh ardt Limited INDIA 371 TZ 14 H 0211 Nadoxin Cream Nadifloxacin Cream 10 mg/ gm Wockh ardt Limited INDIA Registrant: Y.S.P Industries (M) SDN. BDH, MALAYSIA 372 TZ 19 H 0336 Tidact Clindamycin Hydrochloride Capsules 300 mg 373 TZ 19 H 0302 Loradine Loratidi ne Tablets 10 mg Y.S.P INDUSTRIES (M) SDN. BHD Y.S.P Industr ies (M) SDN. BHD MALAYSIA MALAYSIA Registrant: Zhuhai United Laboratories (Zhongshan) Company Limited, CHINA 374 TZ 14 H 0248 Bacozone\-2 Cefoperazone/ combinations Registrant: ZIM Laboratories Ltd, INDIA 375 TZ 19 H 0195 CEFRIM 500 Cefur oxime Axetil 1g +1g Powder for solution for injection CHINA Zhuhai United Laboratories (Zhongshan) Company Limited Film Coated Tablet 500 mg ZIM LABORATORIE S LIMITED INDIA Registrant: ZOTA HEALTHCARE LIMITED , INDIA 376 TZ 19 H 0345 ZOTALOL Atenolol Tablets 100 mg 377 TZ 19 H 0279 Carbamazepine Carbamazepine Tablets 200 mg Registrant: ZOTA HEALTHCARE LIMITED, INDIA 378 TZ 19 H 0377 COLD VAN Chlorpheniramine/ Phenylephr ine Capsules 4 + 5 mg ZOTA HEALTHCARE LIMITED ZOTA HEALTHCARE LIMITED INDIA INDIA ZOTA HEALTHCARE LIMITED INDIA 34 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) MINISTRY OF HEALTH,COMM UNITY DEVELOPMENT,GENDER,ELDERY & CHILDREN TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY P.O. Box 1253 , Dodoma, Tanzania Tel: +255 26 2961989 , 2061 ,990 Fax: +255 22 2450793 Website: www.tmda.go.tz, Email: info@tmda.go.tz LIST OF REGISTERED VETERINARY MEDICINAL PRODUCT S/ N Registration Number Brand Name INN Name Dosage Form Product Strength Manufacturer Country Registrant: Anupco Limited, UNITED KINGDOM 1 TZ 14 V 0026 Iverm ectin 10 Iverm ectin Solution for injection 1% Anupco Limited UNITED KINGDOM Registrant: Ashish Life Science Private Limited, INDIA 2 TZ 14 V 0016 Ashialben 300 Albendazole Bolus 300 mg 3 TAN 09 ,091 P01X ASH Diminashish Diminazene + Phenazone Granules 103 g + 131 g Registrant: Ashish Life Science Pvt Limited., INDIA 4 TZ 19 V 0062 Ashpirazine pip erazine citr ate Powder for Oral solution 100 % Registrant: Bajuta International (T) Ltd, Tanzania 5 TZ 15 V 0018 Baoxytetr a 10 % Oxytetr acycline Hydrochloride Solution for injection 100 mg.ml 6 TZ 15 V 0017 Baoxytetr a 10 % Oxytetr acycline Hydrochloride Solution for injection 100 mg/ ml INDIA INDIA Ashish Life Science Private Limited Ashish Life Science Pvt Limited INDIA Ashish Life Science Private Limited CHINA CHINA Hebei Yuanzheng Pharm aceutical Company limited Hebei Yuanzheng Pharm aceutical Company limited 35 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 7 TZ 15 V 0016 Bamectin Super 50 ml Iverm ectin + Clorsulon Solution 11 g/ 100 ml 8 TZ 19 V 0061 Barocin 10 % Enr ofloxacin oral solution 10 % Solution 100 mg/ ml 9 TZ 15 V 0013 Baoxytetr a 10 % Oxytetr acycline Hydrochloride Solution for injection 100 mg/ ml 10 TZ 15 V 0014 Badex 0.2 Dexameth asone 11 TZ 19 V 0058 Bairon Iron Dextr an Solution for injection 2mg/ ml Solution for injection 200 mg/ ml CHINA CHINA CHINA CHINA CHINA Hebei Yuanzheng Pharm aceutical Company limited Hebei Yuanzheng Pharm aceutical Company limited Hebei Yuanzheng Pharm aceutical Company limited Hebei Yuanzheng Pharm aceutical Company limited Hebei Yuanzheng Pharm aceutical Company Limited Registrant: Bimeda Amea, IRELAND 12 TZ 19 V 0039 Tetr oxy Chick Formu la Oxytetr acycline Hydrochloride Powder 55 / 0.93 / 13 .2/

2.86 / 4.635 mg Chongqing Fangtong Animal Pharm aceutical co. Limited CHINA Registrant: Biovac/ Vireo Biological Industries, ISRAEL 13 TZ09 V001 VIR 116 La Sota str ain Powder 250 mcg/ ml 14 TZ09 V002 VIR 114 Virgo 7 str ain of infectious Bur sal Disease (IBD ) viru s Vaccine

102 .5 EID 50 EID50 ISRAEL ISRAEL Biovac/ Vireo Biologica l Industr ies Biovac/ Vireo Biologica l Industr ies Registrant: Ceva Sante Animale, FRANCE 15 TAN 00 ,4531 P01X CEV Veridi um Isometamidi um Chloride Hydrochloride Powder 1 g Ceva Sant e Animale FRANCE Registrant: Chongqing Bull Animal Pharmaceutical Co., Ltd, CHINA 16 TZ 19 V 0041 Buloxy 10 Oxytetr acycline Injection 10 % CHINA Chongqing Bull Animal Pharm aceutical Co., Ltd Registrant: Cross Vetpharm Group Limited, REPUBLIC OF IRELAND 17 TZ 19 V 0040 Tetr oxy Egg Formu la Oxytetr acycline Hydrochloride Powder 55 / 0.93 / 13 .2/

2.86 / 4.635 mg Chongqing Fangtong Animal Pharm aceutical co. Limited CHINA 36 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) Registrant: Farmers Centre Limited, Tanzania 18 TZ 19 V 0063 Tydox Extr a Tylosin Tartr ate and Doxycycline Hyclate Registrant: FARMERS CENTRE LIMITED, Tanzania Powder for Oral solution 200 / 100 mg/ g Farm ers Centr e Tanzania Limited 19 TZ 19 V 0043 Oxyfarm Eye Wound Powder Oxytetr acycline Hydrochloride Powder 2 % Farm ers Centr e Limited Tanzania Registrant: GENERA INC., CROATIA 20 TZ 19 V 0057 Avishield ND 21 TZ 19 V 0056 Avishield IBD INT - TCID GENERA INC. CROATIA - TCID GENERA INC. CROATIA Lent ogenic Newcastle disease viru s, str ain La Sota Avian Infectious Bur sal Disease viru s (IBDI , int erm ediate str ain VMG 91 ) Lyophili zed live att enuated vaccine Lyophili zed live att enuated vaccine Registrant: GLOBION INDIA PRIVATE LIMITED, INDIA 22 TZ 19 V 0044 GLOBIVAC FOWL POX Fowl Pox Disease Viru s Lyophili zed Injection

0.001-0 .002 ml/ dose Registrant: Hester Biosciences Nepal Pvt. Limited, NEPAL 23 TZ 19 V 0065 Peste Des Petits Rum inant s Vaccine Peste Des Petits Rum inant s Viru s, Nigerian 75 / 1 str ain Registrant: INDOVAX PRIVATE LIMITED, INDIA Vaccine 75 / 1 unit 24 TZ 19 V 0046 Bur sa b2 k Lyophili zed Injection 1200 ml Infectious Bur sal Disease viru s, invasive int erm ediate str ain 25 TZ 19 V 0045 GEORGIA STRAIN Infectious Bur sal Disease Lyophili zed Injection 2000 ml 26 TZ 19 V 0042 newcastle disease vaccine Newcastle disease viru s lasota str ain Lyophili zed Injection 1000 ml Registrant: Interchemie Werken De Adelaar B.V., NETHERLANDS INDIA GLOBION INDIA PRIVATE LIMITED NEPAL Hester Biosciences Nepal Pvt. Limited INDOVAX PRIVATE LIMITED INDOVAX PRIVATE LIMITED INDOVAX PRIVATE LIMITED INDIA INDIA INDIA 27 TZ 19 V 0049 Sulfa-333 Sulfadimidi ne sodium Solution for injection 37 333 mg/ ml Int erchemie Werk en ‘De Adelaar’ B.V Holland Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 28 TZ 19 V 0048 Butachem-50 Buparvaquone Solution for injection 50 mg/ ml Int erchemie Werk en ‘De Adelaar’ B.V 29 TZ 19 V 0047 Nemovit WS 30 TZ 19 V 0060 Intr acox Oxytetr acycline + Neomycin Sulfate + Vitamin K3 Toltr azur il Powder for Oral solution 40 +60 mg/ g Solution 31 TZ 19 V 0051 Dimoxan WS Amoxycol 200 / 1200 ws (Int ern al name) Powder for Oral solution 200 mg + 1200000IU g 32 TZ 19 V 0050 Macrolan WS Tylosine Powder for Oral solution 1000 mg/ g Int erchemie Werk en ‘De Adelaar’ B.V Int erchemie Werk en De Adelaar B.V. Int erchemie Werk en ‘De Adelaar’ B.V Int erchemie Werk en ‘De Adelaar’ B.V Holland Holland NETHERL ANDS Holland Holland Registrant: Invesa International SA, SPAIN 33 TAN 00 ,4602 J 01K INV Ganadexil Enr ofloxacin Solution 10 g/ 100 ml Registrant: Jordan Bio Industries Center (JOVAC), JORDAN 34 TZ 19 V 0055 BRUCE 19 VAC live bacterial Injection 1& 2 35 TZ 19 V 0054 BLACK QUARTER vaccine Clostr idi um chauvoei anacultur e vaccine Suspension for injection 100 ml Registrant: Kela Laboratoria N.V, BELGIUM SPAIN Invesa Industr ial Veterinaria S.A JORDAN JORDAN Jordan Bio Industr ies Cent er Jordan (JOVA Bio C) Industr ies Cent er (JOVA C) 36 TAN 05 ,048 J 01 Mastitis II C PHE Penicilli n G + Neomycin Ointm ent 200000IU +500000IU Kela Laboratoria N.V BELGIUM 37 TAN 09 ,307 OxytoKel 10 I.U Oxytocin Solution 10IU H01B KEL Kela Laboratoria N.V BELGIUM 38 TAN 09 ,308 J 01H KEL Amoxykel 15 % L.A Amoxicilli n tr ihydrate Suspension for injection 150 mg/ ml Kela Laboratoria N.V BELGIUM 39 TAN 05 ,030 J 01 C KEL Masti Kel NP Intr amamm ary 40 TAN 00 ,4571 J 03B PHE Trimazin 30 % Benzyl Penicilli n Procaine + Dihydrost Trimeth oprim + r Sulfameth oxazole eptomycin Ointm ent 2000000IU + 100000IU Kela Laboratoria N.V BELGIUM Powder 250 mg/ g + 50 mg/ g Kela Laboratoria N.V BELGIUM 38 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) 41 TAN 00 ,4560 J 01K KEL Penikan P Registrant: Kela N.V, BELGIUM Kanamycin + Predinisolo ne + Procaine Benzyl Penicilli n Ointm ent Kela Laboratoria N.V BELGIUM 42 TAN 05 ,049 J 01 A PHE Chlort etr acycline tablets Chlort etr acycline Bolus 1000 mg Kela Laboratoria N.V BELGIUM Registrant: MEDISEL (KENYA) LIMITED, KENYA 43 TZ 19 V 0064 Cotr ivet Trimeth oprim + Sulfameth oxazole Powder Registrant: MEDMAC for Manufacturing Agricultural Chemicals & Veterinary Products LTD, JORDAN 44 TZ 19 V 0053 TETRAMED Oxytetr acycline Water Soluble Powder KENYA JORDAN

2.2/ 10 %w/ w ME DIS EL (KE NY A) LI MEDMAC for MI Manufactur ing TE Agricultur al D Chemicals & Veterinary Products LTD 500 mg/ g 45 TZ 19 V 0052 OXYNAL 20 LA Oxytetr acycline 500 mg/ g Long acting injectable solution Registrant: Norbrook Kenya Limited, KENYA 46 TAN 00 ,2078 J 01 A NOR Alamycin Oxytetr acycline Aerosol Spray 36 % w/ v JORDAN MEDMAC for Manufactur ing Agricultur al Chemicals & Veterinary Products LTD NORTHERN IRELAND Norbroo k Laborato ries Limited 39 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY LIST OF MEDICINAL PRODUCTS THAT HAVE BEEN WITHDRAWN FROM 1ST JANUARY 2019 - 31ST DECEMBER 2019 Registration Number INN Name Product Strength Product Form Registrant Name TZ 16 V 0006 TZ 14 V 0019 TZ 17 V 0036 TZ 14 V 0020 TAN 00,4521 C01E WIN TAN 00,4522 C01E WIN Brand Name Anflox Feed Premix OTC 20% OTC Plus Cotrim 480W Variac e Variac e Norfloxacin 10% Powder Oxytetracyc line Oxytetracyc line + Vitamins Sulfadiazine + Trimethopri m Ramipril 20% Powder 6% 48% Powder for Oral solution Powder for Oral solution

2.5mg Capsules Ramipril 5mg Capsules TAN 07,101 J03C REG Urisept ic Nalidixic Acid 500 mg Tablets TAN 00,694 J05A E.D Acyclo vir Denk Acyclovir 5% w/w Cream TAN 00,691 D01A E.D Clotri Denk Clotrimazol e 1% w/w Cream 1 2 3 4 5 6 7 8 9 10 TAN 00,682 M01A E.D Diclo Denk Rectal Diclofenac 100 mg Supposito ries 11 TZ 19 H 0001 PREZI STA Darunavir 100 mg/ml Suspensi on, Oral Registrant Country UNITED KINGDOM Manufactu rer Name Anupco Limited UNITED KINGDOM UNITED KINGDOM UNITED KINGDOM INDIA INDIA KENYA GERMANY GERMANY GERMANY Anupco Limited Anupco Limited Anupco Limited Win- Medicare Private Limited Win- Medicare Private Limited Regal Pharmac euticals Limited Denk Pharma GmbH & Co. KG Denk Pharma GmbH & Co. KG Denk Pharma GmbH & Co. KG Manufactur er Country UNITED KINGDO M UNITED KINGDO M UNITED KINGDO M UNITED KINGDO M INDIA INDIA KENYA GERMAN Y GERMAN Y GERMAN Y BELGIUM Janssen Ortho LLC United States of America Anupco Limited Anupco Limited Anupco Limited Anupco Limited Win- Medicare Private Limited Win- Medicare Private Limited Regal Pharmace uticals Limited Denk Pharma GmbH & Co. KG Denk Pharma GmbH & Co. KG Denk Pharma GmbH & Co. KG Janssen- Cilag Internatio nal NV 12 TAN 00,855 H02A S-P Celesto ne Betamethas one 4 mg/ml Solution for injection MSD (Pty) Limited SOUTH AFRICA 13 TZ 14 H 0140 14 TZ 14 H 0235 15 TZ 15 H 0178 16 TZ 15 H 0177 Omepr az 20 Almox 500 Clava m

562.5 Clava m 1125 Omeprazole 20mg Capsules, hard Amoxicillin 500mg Capsules amoxicillin and clavulanic acid amoxicillin and clavulanic acid Tablets 500 mg + 62.5 mg Tablets 1000 mg + 125mg INDIA INDIA INDIA INDIA Alkem Laborator ies Limited Alkem Laborator ies Limited Alkem Laborator ies Limited Alkem Laborator ies Limited BELGIUM INDIA INDIA INDIA INDIA Schering Plough Laborato ries N.V ALKEM LABOLAT ORIES LTD ALKEM LABOLAT ORIES LIMITED ALKEM LABORA TORIES LIMITED ALKEM LABORA TORIES LIMITED 40 Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY LIST OF MEDICINAL PRODUCTS THAT HAVE BEEN WITHDRAWN FROM 1ST JANUARY 2019 - 31ST DECEMBER 2019 Product Form Tablets Tablets Powder for Injection Powder for Injection Powder for Injection Powder for Suspensi on Powder for Reconstit ution Capsules Registration Number 17 TZ 16 H 0026 18 TZ 16 H 0027 Brand Name TSART 40 TSART 80 INN Name Telmisartan Telmisartan Product Strength Telmisa rtan USP 40 mg Telmisa rtan 80 19 TZ13H175 Zocef Cefuroxime Sodium

1.5g/vi al 20 TZ13H015 ZOCEF Cefuroxime Sodium 750mg 21 TZ13H003 22 TZ 16 H 0056 MEGA PIME INJEC TION 1G CoVals ar- Denk 320/1

2.5 Cefipime 1g/vial Valsartan and diuretics 320/12 .5 mg Tablets TAN 00,4058 J01C ALK Broadi clox Ampicillin + Cloxacillin Capsules 250 mg + 250 mg TAN 00,4061 J01K ALK Vanco gen Vancomycin 500 mg Injection TAN 07,426 J01C ALK Broadi clox Ampicillin + Cloxacillin TAN 07,425 J01C ALK Fluclo xacillin Flucloxacilli n 125 mg/5m l + 125 mg/5m l 125 mg 27 TZ13H052 Duspa tallin Mebeverine 200 mg TAN 00,1715 V03A SOL Betase rc Betahistine \N Tablets TAN 00,2205 A03A SOL Duspa tallin Mebeverine \N Tablets TAN 00,1247 N04C SOL Faveri n Fluvoxamin e \N Tablets TAN 00,692 N02B E.D Diclo Denk Diclofenac Sodium TAN 00,2354 P02X KEL TAN 05,777 J01A KEL Pipera zine Citrate 100% POWD ER Doxyco l Piperazine 73 mg/3 ml 100 %w/w Injection Powder for Oral solution Doxycycline + Colistine 500mg /g+500 mg/g Powder TAN 00,1310 J01A KEL Oxytet ra Oxytetracyc line 10 % w/v 35 TZ13H065 Oxytoc in Oxytocin 5 Units / ml 23 24 25 26 28 29 30 31 32 33 34 Solution for injection Solution for injection 41 Registrant Name Registrant Country Manufactu rer Name Manufactur er Country INDIA INDIA INDIA INDIA INDIA GERMANY INDIA INDIA INDIA INDIA SOUTH AFRICA SOUTH AFRICA SOUTH AFRICA SOUTH AFRICA GERMANY BELGIUM BELGIUM BELGIUM GERMANY Alkem Laborator ies Limited Alkem Laborator ies Limited Alkem Laborator ies Limited Alkem Laborator ies Limited Alkem Laborator ies Limited Denk Pharma GmbH & Co. KG Alkem Laborator ies Limited Alkem Laborator ies Limited Alkem Laborator ies Limited Alkem Laborator ies Limited Abbott Laborator ies S.A (Pty) Ltd. Abbott Laborator ies S.A (Pty) Ltd. Abbott Laborator ies S.A (Pty) Ltd. Abbott Laborator ies S.A (Pty) Ltd. Denk Pharma GmbH & Co. KG Kela Laborator ia N.V Kela Laborator ia N.V Kela Laborator ia N.V Rotexmed ica GmbH Arzneimit telwerk INDIA INDIA INDIA INDIA INDIA GERMAN Y INDIA INDIA INDIA INDIA NETHERL ANDS NETHERL ANDS NETHERL ANDS NETHERL ANDS GERMAN Y BELGIUM BELGIUM BELGIUM GERMAN Y Alkem Laborato ries Limited Alkem Laborato ries Limited Alkem Laborato ries Limited Alkem Laborato ries Limited. Alkem Laborato ries Limited Denk Pharma GmbH & Co. KG Alkem Laboratorie s Limited Alkem Laboratorie s Limited Alkem Laboratorie s Limited Alkem Laboratorie s Limited Solvay Pharmac eutical B.V Solvay Pharmac eutical B.V Solvay Pharmac euticals B.V Solvay Pharmac euticals B.V Haupt Pharma Wulfing GmbH Kela N.V Kela Laborato ria N.V Kela Laborato ria N.V Rotexme dica GmbH Arzneimit telwerk Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY LIST OF MEDICINAL PRODUCTS THAT HAVE BEEN WITHDRAWN FROM 1ST JANUARY 2019 - 31ST DECEMBER 2019 Registration Number 36 TAN 08,155 N04A ROT Brand Name Suxam ethoni um Chlori de INN Name Suxametho nium Chloride Product Strength 250 mg/ml Product Form Solution for injection 37 38 39 TAN 00,1185 P02X REG Meben dazole Mebendazol e 100 mg Tablets TAN 09,061 V03A REG TAN 05,155 B01A CLA Sonate c Mouth wash Hepare n Cetylpyridin ium 005 %w/v Solution Heparin Sodium 5000 IU/ml Solution for injection 40 TZ 14 H 0110 Dflam Diclofenac 25mg/ ml Solution for injection 41 TZ 14 H 0200 42 TZ13H102 43 44 TAN 00,690 C01E E.D TAN 00,698 M01A E.D 45 TZ13H222 Levo- Denk 250 Nucleo CMP Forte Injecti on Captop ril Denk Diclo Denk 50 Glibom et Levofloxacin 250mg Tablets CMP disodium salt + UTP trisodium salt Captopril 10mg + 6mg Powder for Injection 25 mg Tablets Diclofenac 50 mg Tablets Metformin Hydrochlori de USP Glibenclami de Tablets

400.0m g/2.5m g 46 47 48 49 50 51 TAN 06,102 J01K S.A Ciloxa n Ciprofloxaci n TAN 00,1761 S01G ALC Cusicr om Sodium Cromoglyca te 3 mg/5m l 40 mg/ml TAN 06,332 S01D S.A TAN 00,2247 P02X FAT TAN 00,4596 B01A FAT TAN 09,055 C01E NOV Pilocarpine \N Levamisole \N Iron Dextran Valsartan + Hydrochloro thiazide \N 80mg + 5mg Isopto Carpin e Pamizo le L Endofe r Co- Diovan Valzaa r - 80 Ophthal mic Solution Ophthal mic Solution Ophthal mic Solution Injectable Solution Injectable Solution Tablet, Film- coated 52 TZ14H085 Valsartan 80mg Tablets 53 TAN 09,205 L01C SCH Caelyx Doxorubicin \N Injectable Solution 42 Registrant Name Rotexmed ica GmbH Arzneimit telwerk Regal Pharmace uticals Limited Regal Pharmace uticals Limited BAXTER PHARMA CEUTICA LS INDIA PRIVATE LIMITED ELDA Internatio nal DMCC Denk Pharma GmbH & Co. KG Ferrer Internaci onal, S.A. Denk Pharma GmbH & Co. KG Denk Pharma GmbH & Co. KG Laborator i Guidotti S.P.A Registrant Country GERMANY KENYA KENYA INDIA U.A.E GERMANY SPAIN GERMANY GERMANY ITALY S K Age Exports INDIA Manufactu rer Name Rotexme dica GmbH Arzneimit telwerk Regal Pharmac euticals Limited Regal Pharmac euticals Limited BAXTER PHARMA CEUTICA LS INDIA PRIVATE LIMITED BAXTER PHARMA CEUTICA LS INDIA PRIVATE LIMITED Rottendo rf Pharma GmbH Ferrer Internaci onal, S.A. Denk Pharma GmbH & Co. KG Denk Pharma GmbH & Co. KG A.Menari ni Manufact uring Logistic and Services S.r.l SA Alcon- Couvreur NV Alcon Cusi,S.A. Manufactur er Country GERMAN Y KENYA KENYA INDIA INDIA GERMAN Y SPAIN GERMAN Y GERMAN Y ITALY BELGIUM SPAIN SWITZERLA ND Norvatis Pharma AG S K Age Exports INDIA S K AGE Exports INDIA Fatro SPA ITALY Fatro SPA ITALY KENYA INDIA SOUTH AFRICA NVS Kenya Limited Torrent Pharmace uticals Limited Schering Plough Proprietar y Limited Fatro SPA Fatro SPA Novartis Vaccines and Diagnosti cs Torrent Pharmac euticals Limited Ben. Venue Laborato ries ITALY ITALY ITALY INDIA United States of America Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY LIST OF MEDICINAL PRODUCTS THAT HAVE BEEN WITHDRAWN FROM 1ST JANUARY 2019 - 31ST DECEMBER 2019 Registration Number 54 55 56 TAN 00,225 A10A NOV TAN 00,228 A10A NOV TAN 00,795 A10A NOV 57 TZ 14 H 0128 58 TZ14H017 59 TZ14H016 60 TZ12H042 61 TZ 15 H 0408 62 TZ14H010 63 TZ14H008 64 TZ14H007 65 TZ14H009 66 TZ14H011 67 TZ 14 H 0255 68 TZ 16 H 0233 69 TZ 15 H 0311 70 TZ 15 H 0320 71 TZ 15 H 0321 72 TZ 16 H 0183 73 TZ 16 H 0184 Brand Name Actrapi d HM Insulat ard HM Penfill Mixtar d Amlibo n Ospam ox 125mg /5ml Ospam ox 500mg Curam 125mg /5ml Azithro mycin sandoz Biodro xil 500mg Capsul es Biodro xil 250mg /5ml Biodro xil 500mg /5ml Biodro xil 125mg /5ml Biodro xil 1000m g Nexme zole Sando z 20mg Glimep irid Sando z Andar an IRBES ARTAN HCT SAND OZ Andar an HCT Omepr azole Sando z Omepr azole Sando z INN Name Insulin Insulin Insulin Product Strength 100 IU/ml 100 IU/10 ml 100IU/ ml Product Form Solution Injection Injection Amlodipine 5mg Tablets Amoxycillin 125mg /5ml Amoxicillin 500mg Powder for Oral Suspensi on Tablets Amoxycillin + Clavulanate Potassium Azithromyci n 125mg /5ml +

31.25m g/5ml 250 mg Powder Tablets Cefadroxil 500mg Capsules Registrant Name Registrant Country Novo Nordisk(p ty) Limited Novo Nordisk A/S Novo Nordisk(p ty) Limited NVS Kenya Limited Sandoz GmbH Sandoz GmbH Sandoz GmbH Sandoz GmbH Sandoz GmbH SOUTH AFRICA GREECE SOUTH AFRICA KENYA AUSTRIA AUSTRIA AUSTRIA AUSTRIA AUSTRIA Cefadroxil 250mg /5ml Suspensi on Sandoz GmbH AUSTRIA Cefadroxil Cefadroxil 500mg /5ml 125mg /5ml Powder for Suspensi on Suspensi on NVS Kenya Limited Sandoz GmbH KENYA AUSTRIA Cefadroxil 1000m g Tablets Sandoz GmbH AUSTRIA Manufactu rer Name Novo Nordisk Manufactur er Country DENMAR K Novo Nordisk A/S Novo Nordisk A/S Lek Pharmac euticals d.d. Sandoz GmbH Sandoz GmbH Sandoz GmbH Sandoz S.R.L Sandoz GmbH Sandoz GmbH Sandoz GmbH Sandoz GmbH Sandoz GmbH DENMAR K DENMAR K SLOVENI A AUSTRIA AUSTRIA AUSTRIA Romania AUSTRIA AUSTRIA AUSTRIA AUSTRIA AUSTRIA Esomeprazo le 20mg Tablets Glimepiride 3 mg Tablets AUSTRIA Salutas Pharma GmbH GERMAN Y AUSTRIA LEK S.A. Poland Irbesartan 75 mg Tablet, Film- coated Tablets 150+12 .5 mg AUSTRIA AUSTRIA Irbesartan and Hydrochloro thiazide Irbesartan and Hydrochloro thiazide Omeprazole 300+12 .5 mg Tablets Sandoz GmbH AUSTRIA 10 mg Capsules Sandoz GmbH AUSTRIA Omeprazole 20 mg Capsules Sandoz GmbH AUSTRIA 43 SLOVENI A SLOVENI A SLOVENI A SLOVENI A SLOVENI A Lek Pharmac euticals d.d. Lek Pharmac euticals d.d. Lek Pharmac euticals d.d. LEK PHARMA CEUTICA LS D.D. LEK PHARMA CEUTICA LS D.D. Sandoz GmbH Sandoz GmbH Sandoz GmbH Sandoz GmbH Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY LIST OF MEDICINAL PRODUCTS THAT HAVE BEEN WITHDRAWN FROM 1ST JANUARY 2019 - 31ST DECEMBER 2019 INN Name Product Strength Product Form Registrant Name Registrant Country Registration Number 74 TZ 16 H 0182 75 TZ 15 H 0144 76 TZ 15 H 0146 77 TZ 15 H 0145 78 TZ 15 H 0322 79 TZ 14 H 0113 Brand Name Omepr azole sandoz PERIN DAL PANOP RIST PANOP RIST PIPER ACILLI N/TAZ OBAC TAM SAND OZ Robest ar Omeprazole 40 mg Perindopril 2 mg Powder for solution for injection Tablets Perindopril 8 mg Tablets Perindopril 4 mg Tablets Piperacillin and enzyme inhibitor

2.25 g Powder for solution for injection Rosuvastati n 10mg Tablets 80 TZ 14 H 0164 Robest ar Rosuvastati n 20mg Tablets 81 TZ14H018 TAN 07,237 R06A UCB TAN 06,343 N04B UCB TAN 06,342 N04B UCB Ospam ox 250mg /5ml Cirrus Amoxicillin Cetrizine + Pseudoephe drine 250mg /5ml 5mg + 120mg Atarax Hydroxyzine \N Powder for Oral Suspensi on Tablets Tablet, Film- coated Aterax Hydroxyzine \N Syrup TAN 00,272 J03B SKB Cotreic h Sulfametho xazole+Trim ethoprim \N Tablets 86 TAN 00 2152 D07A GLA Cutiva te Fluticosone 0005 % w/w Ointment TAN 00,274 J03B SKB Cotreic h Sulfametho xazole+Trim ethoprim \N Suspensi on TAN 00,1706 B03A SKB 90 TZ 15 H 0271 91 TZ 15 H 0270 Ferrous Sulphate + Folic Acid 150 mg + 05 mg Spansule s Fluticasone 125 mcg Suspensi on, Oral Fluticasone 50 mcg Suspensi on, Oral Fefol Spans ule Flixoti de Evohal er Flixoti de Evohal er 44 82 83 84 85 88 89 Sandoz GmbH AUSTRIA AUSTRIA AUSTRIA AUSTRIA AUSTRIA KENYA KENYA AUSTRIA KENYA KENYA KENYA KENYA KENYA Sandoz GmbH Sandoz GmbH Sandoz GmbH Sandoz GmbH NVS Kenya Limited NVS Kenya Limited Sandoz GmbH GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Pharmace utical Kenya Limited GlaxoSmi thKline Limited KENYA KENYA KENYA KENYA GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited Manufactur er Country SLOVENI A SLOVENI A SLOVENI A SLOVENI A AUSTRIA SLOVENI A SLOVENI A AUSTRIA ITALY SOUTH AFRICA SOUTH AFRICA INDIA UNITED KINGDO M UNITED KINGDO M INDIA EGYPT SPAIN SPAIN Manufactu rer Name LEK PHARMA CEUTICA LS D.D. Lek Pharmac euticals d.d. Lek Pharmac euticals d.d. Lek Pharmac euticals d.d. Sandoz GmbH Lek Pharmac euticals d.d. Lek Pharmac euticals d.d. Sandoz GmbH Aesica Pharmac euticals S.R.L Aspen Port Elizabeth Aspen Port Elizabeth Medreich Formulat ion Pvt Limited. GlaxoSmi thkline Operatio ns (UK) Limited GlaxoSmi thkline Operatio ns(UK) Limited Medreich Formulat ion Pvt Limited. GlaxoSmi thKline Egypt Glaxo Wellcome S.A Glaxo Wellcome S.A 87 TAN 00, 590 J01C SMI Clavuli n Amoxicillin + Clavulanate 875 mg + 125 mg Tablets GlaxoSmi thKline Limited KENYA Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY LIST OF MEDICINAL PRODUCTS THAT HAVE BEEN WITHDRAWN FROM 1ST JANUARY 2019 - 31ST DECEMBER 2019 Registration Number 92 TZ 15 H 0269 93 TAN 00,355 M03B AMO Brand Name Flixoti de Evohal er Myolgi n INN Name Fluticasone Product Strength 250 mcg Product Form Suspensi on, Oral Chlorzoxazo ne + Paracetamol 250 mg + 300 mg Capsules, hard 94 TZ12H063 Pirsec Omeprazole 20 mg + 1110 mg 40 mg + 1100 mg 200 + 25 micro gram 100 + 25 micro gram \N Capsules Tablets Powder for inhalatio n Powder for inhalatio n Tablets Pirsec Tablets 40mg/ 1100m g Relvar Ellipta 184/2 2 Relvar Ellipta 92/22 Zagole Omeprazole + Sodium bicarbonate Vilanterol and fluticasone furoate Vilanterol and fluticasone furoate Metronidazo le Zantac Ranitidine 150 mg Tablets 95 TZ12H064 96 TZ 16 H 0313 97 TZ 16 H 0314 98 99 TAN 00,289 P02X SKB TAN 00,317 A02B GLA 100 TAN 00,318 A02B GLA Zantac Ranitidine 300 mg Tablets 101 102 103 104 TAN 00,1904 P02X SKB Zentel Albendazole \N Tablets TAN 06,345 R06A UCB Zyrtec Cetirizine Dihydrochlo ride BP 10 mg/ml Drops TAN 09,141 J02A GSK Zilcan Fluconazole \N Suspensi on TAN 00,1817 J01D GLA Zinnat Cefuroxime \N Tablets Registrant Country KENYA KENYA KENYA KENYA KENYA KENYA KENYA KENYA Registrant Name GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited KENYA KENYA KENYA KENYA KENYA GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited GlaxoSmi thKline Limited 105 TZ 15 H 0418 Eno Orange ANTACIDS

43.14 + 10 % Powder for Oral solution Glaxosmi thKline Limited KENYA 106 TZ 15 H 0232 Zeben 200 Albendazole 200mg Tablets 107 TAN 00,121 D01A JAN Nizoral Ketoconazole 20 mg/g Cream 108 TZ 15 H 0404 Navom Granisetron 1 mg/ml Solution for injection KENYA SOUTH AFRICA U.A.E Sanofi Aventis Kenya Limited Janssen Pharmace utica Proprietar y Limited ELDA Internatio nal DMCC 45 Manufactur er Country SPAIN EGYPT United States of America United States of America UNITED KINGDO M UNITED KINGDO M INDIA KENYA KENYA FRANCE ITALY INDIA UNITED KINGDO M KENYA INDIA SOUTH AFRICA INDIA Manufactu rer Name Glaxo Wellcome S.A GlaxoSmi thKline Egypt Norwich Pharmac euticals Norwich Pharmac euticals Glaxo Operatio ns UK Limited Glaxo Operatio ns UK Limited Medreich Sterilab Limited GlaxoSmi thKline Pharmac eutical Kenya Limited GlaxoSmi thKline Pharmac eutical Kenya Limited Glaxo Wellcome Productio n Aesica Pharmac euticals S.R.L Medreich Sterilab Limited GlaxoSmi thkline Operatio ns(UK) Limited GlaxoSmi thKline Pharmac eutical Kenya Limited Medreich Limited,U nit 6 Janssen Pharmac eutica (Pty) Limited BAXTER PHARMA CEUTICA LS INDIA PRIVATE LIMITED Tanzania Medicines and Medical Diveces (List of Registered and Cancelled Medicines) GN. No. 187 (contd.) TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY LIST OF MEDICINAL PRODUCTS THAT HAVE BEEN WITHDRAWN FROM 1ST JANUARY 2019 - 31ST DECEMBER 2019 Registration Number Brand Name INN Name 109 TZ 15 H 0405 Navom Granisetron 110 TZ 14 H 0309 Ansed Flumazenil 111 TZ 15 H 0136 Dobine Dobutamine Product Strength 1 mg/ml Product Form Solution for injection Injection 225mg /200m g/25m g

12.5 mg/ml Injection 112 TZ 14 H 0327 Cardos ine Adenosine 3 mg/ml Solution for injection 113 114 TAN 00,230 A02B CAP TAN 00,250 A02B CAH Aciloc Ranitidine 150 mg Tablets R Loc Ranitidine \N Tablets 115 TZ12H141 Rantac Ranitidine Hydrichlori de 500 mg/ml Solution for injection 116 117 118 119 120 121 TAN 00,1895 A02B REM TZ 14 H 0232 TAN 00,845 D07A S-P TAN 00,1132 A02B MDC Ranipl ex Consiu m - 100 Eloco m Ulcera n Ranitidine 150 mg Tablets Carmustine 100mg Intraveno us Infusion Mometason e Famotidine 1 %w/w \N Lotion Tablets TAN 00,1134 J01F MDC Porphy rocin Erythromyci n 250mg Tablet, Film- coated Suspensi on for injection 20 mcg/0 5 ml TAN 05,689 J07A SHA Shanv ac-B 122 TAN 05,686 J07A SHA Shanv ac-B Purified Hepatitis-B surface antigen (HBsAg) Purified Hepatitis-B surface antigen (HBsAg) Registrant Name ELDA Internatio nal DMCC BAXTER PHARMA CEUTICA LS INDIA PRIVATE LIMITED ELDA Internatio nal DMCC BAXTER PHARMA CEUTICA LS INDIA PRIVATE LIMITED Cadila Pharmace uticals Limited Cadila Healthcar e Limited Unique Pharmace utical Laborator ies (A Division of J.B. Chemical s & Pharmace uticals Limited) Remedica Limited Emcure Pharmace uticals Limited MSD (Pty) Limited Medoche mie Limited Medoche mie Limited Sanofi Pasteur Registrant Country U.A.E INDIA U.A.E INDIA INDIA INDIA INDIA CYPRUS INDIA SOUTH AFRICA CYPRUS CYPRUS KENYA Manufactur er Country INDIA INDIA INDIA INDIA INDIA INDIA INDIA CYPRUS INDIA CANADA CYPRUS CYPRUS INDIA INDIA Manufactu rer Name BAXTER PHARMA CEUTICA LS INDIA PRIVATE LIMITED BAXTER PHARMA CEUTICA LS INDIA PRIVATE LIMITED BAXTER PHARMA CEUTICA LS INDIA PRIVATE LIMITED BAXTER PHARMA CEUTICA LS INDIA PRIVATE LIMITED Cadila Pharmac euticals Limited Cadila Healthca re Limited Unique Pharmac eutical Laborato ries (A Division of J.B Chemical s and Pharmac euticals Limited) Remedica Limited Emcure Pharmac euticals Pvt. Ltd. Bayer Inc Medoche mie Limited Medoche mie Limited Shantha Biotechni cs Limited. Shantha Biotechni cs Limited. 20 mcg/m l Suspensi on for injection Sanofi Pasteur KENYA 46