Approved Medicine Product Information

Approved Product Information

In an effort to promote openness and transparency in medicines regulation and to build the publics’ confidence in our processes, the Authority has started publishing summaries of product characteristics (SmPCs) and public assessment reports (TPAR) for selected medicines granted marketing authorization in Tanzania Mainland.

Summary of Product Characteristics (SmPCs)

This provides information about medicinal product’s properties and the conditions attached to its use including how it should be prescribed. Publication of approved SmPC is an additional step towards ensuring that healthcare providers and patients get adequate information to enable correct use of medicines.

list of approved SmPCs
Tanzania Public Assessment Reports (TPAR)
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1.Alfuzosin 10 mg TabletsAlfuzosin 10 mg Tablets
2AlrinastDesloratadine 5 mg film coated tablets
3AmoxicillinAmoxicillin 500 mg capsule
4 AmoxicillinAmoxicillin 250 mg capsule
5.Atenolol 100 mg TabletsAtenolol 100 mg Tablets
6AtorkeyAtorvastatin 20 mg tablets
7.Atorvastatin 10 mg TabletsAtorvastatin 10 mg Tablets
8.Atorvastatin 20 mg TabletsAtorvastatin 20 mg Tablets
9A – GLIPSitagliptin Phosphate Monohydrate Tablets 50mg
10ALCEF 500Ceftriaxone Sodium Dry Powder for injection 500mg
11ALCEF-SBCeftriaxone Sodium & Sulbactam Dry Powder for Injection 1 g+0.5 g
12Amlovie 10Amlodopine Tablet 10mg
13AMLOVIE 5Amlodopine Tablet 5mg
14Atoneura 40Atomoxetine Hydrochloride Hard gelatin Capsules 40mg
15AUROPODOX 40Cefpodoxime Proxetil Powder for Oral Suspension of 40 mg/5 mL
16AXACIPCiprofloxacin Solution for Infusion 200mg/100 ml
17AXAFLOX-IOfloxacin Opthalmic solution of 0.3% w/v
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1.Bisoprolol 10 mg TabletsBisoprolol 10 mg Tablets
2.Bisoprolol 5 mg TabletsBisoprolol 5 mg Tablets
3BortebinBortezomib 3.5 mg powder for solution for injection
4Bevamab 100Bevacizumab Solution for infusion 100mg/4mL
5BEXITROL-F 25/125Salmeterol Xinafoate + Fluticasone Propionate Aerosol Suspension inhaler of 25 µg + 125 µg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1Calcium folinateCalcium folinate 50 mg/5 mL solution for injection
2CandivorVoriconazole 200 mg/vial injection
3CarfilnatCarfilzomib 60 mg/vial lyophilized powder for injection
4CetaforCeftriaxone 500 mg powder for injection
5CetaforCeftriaxone 1000 mg powder for injection
6ChlorphenamineChlorphenamine 5 mg tablets
7ClotripinClotrimazole 1% w/w cream
8Cornizole dentaMetronidazole 1% w/w gel
9CACHEWORMMebendazole Oral Suspension of 100 mg/5mL
10CACHEWORMMebendazole Uncoated tablet of 100 mg
11Cardiolek - 320Iodixanol Solution for Injection 320mg
12CARFILNATCarfilozimab Lyophilized powder for injection each 1 ml contains 2mg of Carfilozimab
13CEFUTILCefuroxime Axetil Film coated tablets of 500 mg
14CEPHAXIMCefalexin Monohydrate Hard gelatin capsules 250 mg
15CHLORURE DE SODIUM 0.9% UNIMEDSodium Chloride Solution for infusion 0.9% w/v
16CIPROBID 500Ciprofloxacin Hydrochloride Film coated Tablets 500 mg
17Cisteen InjectionCisplatin Solution for Injection 50mg/50ml
18COMFORAPentosan Polysulfate Sodium
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1DacarbazineDacarbazine 200 mg/vial injection
2Dapzin-10Dapagliflozin 10 mg tablets
3Dapzin-5Dapagliflozin 5 mg tablets
4DermicolonTriamcinolone acetonide 0.1% w/w ointment
5DAPOXEM 30Dapoxetine Hydrochloride Hard Gelatin Capsule 100mg
6DAPOXEM 60Dapoxetine Hydrochloride Film coated tablets 60 mg
7DAPTOMYCINDaptomycin Lyophilized powder for reconstitution for injection 500 mg
8DelstrigoTMDoravirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablet 100mg+300mg+300mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1ElosoneMometasone furoate 0.1%w/w
2EnoxamedEnoxaparin Sodium Solution for Injection in Pre filled Syringes 4000 IU/0.4 mL
3EnoxamedEnoxaparin Sodium Solution for Injection in Pre filled Syringes 6000 IU/0.6 mL
4EnoxamedEnoxaparin Sodium Solution for Injection in Pre filled Syringes 2000 IU/0.2 mL
5EnoxamedEnoxaparin Sodium Solution for Injection in Pre filled Syringes 8000 IU/0.8 mL
6Enzystal PPancreatin "Enteric Coated Tablets Amylase activity 4200 Ph. Eur. Units Lipase activity 3500 Ph. Eur. Units Protease activity 250 Ph. Eur. units "
7EPSYLAM DT 100Lamotrigine Dispersible Tablets 100mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1Fixet 200Cefixime 200 mg tablets
2FAROGLIP S 50Sitagliptin Phosphate Monohydrate Film Coated Tablet 50mg
3Fluzyn­20Fluoxetine Hydrochloride Hard Gelatin Capsules 20mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1.Gliclazide 30 mg TabletsGliclazide 30 mg Tablets
2.Gliclazide 30 mg TabletsGliclazide 30 mg Tablets
3.Gliclazide 60 mg TabletsGliclazide 60 mg Tablet
4.Glimepiride 1 mg TabletsGlimepiride 1 mg Tablets
5.Glimepiride 2 mg TabletsGlimepiride 2 mg Tablets
6.Glimepiride 2 mg TabletsGlimepiride 2 mg Tablets
7.Glimepiride 3 mg TabletsGlimepiride 3 mg Tablets
8.Glimepiride 3 mg TabletsGlimepiride 3 mg Tablets
9.Glimepiride 4 mg TabletsGlimepiride 4 mg Tablets
10.Glimepiride 4 mg TabletsGlimepiride 4 mg Tablets
11.Glimepiride 4 mg TabletsGlimepiride 4 mg Tablets
12G-CEFTRIACeftriaxone Sodium Sterile Powder for Injection 1g
13GemcitabineGemcitabine hydrochloride Lyophilized Powder for Injection 200 mg
14GENCEF-1Ceftriaxone Sodium Dry Powder 1000mg
15GENLEX 125MG/5MLCephalexin Monohydrate Dry Powder for Oral Suspension 125mg
16Gentamicin SulfateGentamicin Sulfate Solution for injection 80mg/2mL
17GMYCIN 80Gentamicin Sulfate Solution for injection 80 mg/2mL
18GMYCIN 80Gentamicin Sulfate Solution for injection 80mg/2ml
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1.Human Insulin Human Insulin
2.Human Insulin Human Insulin
3.Human Insulin 3 mlHuman Insulin 3 ml
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1.Insulin DetemirInsulin Detemir
2.Insulin GlargineInsulin Glargine
3IntaflamIbuprofen 400 mg + Paracetamol 325 mg
4INNOFIX 400Cefixime Trihydrate Hard Gelatin Capsules of 400 mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1KlarClarithromycin 500 mg tablets
2KlarClarithromycin 250 mg tablets
3KLABIL™ BIDAmoxicillin Trihydrate and Clavulanic Acid Powder for Oral Suspension 200 mg / 5 mL + 28.5 mg / 5 Ml
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1Letrozole Denk 2.5Letrozole 2.5 mg
2LevorestLevonogestrel 0.15 mg + Ethynylestradiol 0.03 mg
3Lulizol creamLuliconazole 1%w/w cream
4Lamivudine/Nevirapine/ZidovudineLamivudine/Nevirapine/Zidovudine Tablet 150 mg+200 mg+300 mg
5LariactArtemether + Lumefantrine Dispersible Tablets 20mg+120mg
6LEVEGET TMLevetiracetam Film coated tablet 250mg
7LEVEGET TMLevetiracetam Film coated tablet 500mg
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SUMMARY OF PRODUCT CHARACTERISTICS
S/NProduct NameGeneric name
1MaxalyteOral Rehydration Salts
2MeloxicamMeloxicam 15 mg tablets
3 MeloxicamMeloxicam 7.5 mg tablets
4.Metformin Hydrochloride 1000 mg TabletsMetformin Hydrochloride 1000 mg Tablets
5.Metformin Hydrochloride 1000 mg TabletsMetformin Hydrochloride 1000 mg Tablets
6.Metformin Hydrochloride 500 mg Tablets XRMetformin Hydrochloride 500 mg Tablets XR
7.Metformin Hydrochloride 500 mg TabletsMetformin Hydrochloride 500 mg Tablets
8.Metformin Hydrochloride 500 mg TabletsMetformin Hydrochloride 500 mg Tablets
9.Metformin Hydrochloride 500 mg TabletsMetformin Hydrochloride 500 mg Tablets
10.Metformin Hydrochloride 500 mg TabletsMetformin Hydrochloride 500 mg Tablets
11.Metformin Hydrochloride 500 mg Tablets XRMetformin Hydrochloride 500 mg Tablets XR
12.Metformin Hydrochloride 750 mg TablestMetformin Hydrochloride 750 mg Tablest
13.Metformin Hydrochloride 750 mg TabletsMetformin Hydrochloride 750 mg Tablets
14.Metformin Hydrochloride 750 mg Tablets XRMetformin Hydrochloride 750 mg Tablets XR
15.Metformin Hydrochloride 850 mg TabletsMetformin Hydrochloride 850 mg Tablets
16.Metformin Hydrochloride 850 mg TabletsMetformin Hydrochloride 850 mg Tablet
17.Metformin Hydrochloride 850 mg TabletsMetformin Hydrochloride 850 mg Tablets
18.Metformin Hydrochloride 850 mg TabletsMetformin Hydrochloride 850 mg Tablets
19.Metformini Hydrochloride 500 mg TabletsMetformini Hydrochloride 500 mg Tablets
20MetoMetoclopromide 10 mg tablets
21Mphetas-500Mycophenolate Mofetil 500 mgTablets
22MyhepSofosbuvir 400 mg tablets
23Mebaal ODS 1500Mecobalamin Orally disintegrating strips of 1500 mcg
24MOFECON-S 180Mycophenolic Acid (as Mycophenolate Sodium) Mycophenolic Acid 180 mg
25MOFECON-S 360Mycophenolic Acid (as Mycophenolate Sodium) Mycophenolic Acid 360 mg
26MOFLOXMoxifloxacin Hydrochloride Film coated tablets of 400 mg
27MOXIGET IVMOXIFLOXACIN HYDROCHLORIDE Solution for infusion 400 mg/ 250 mL
28Mycept –S 180Mycophenolate sodium Delayed Release Tablet 180mg
29MYCOPHENOLIC ACIDMycophenolate Sodium Gastro resistant tablets 360 mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1Novator 500Deferiprone Hard gelatin Capsules 500mg
2NSSodium Chloride Intravenous Infusion 0.9%
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1Ondansetron orodispersible tabletsOndansetron orodispersible 8 mg tablets
2Oratane 40Isotretinoin 40 mg soft gelatin capsules
3ORILAM ODT 100Lamotrigine Disintegrating Tablets 100mg
4ORILAM ODT 50Lamotrigine Disintegrating Tablets 50mg
5OZINC-DTZinc Sulfate Monohydrate Zinc Sulfate Monohydrate Equivalent to Zinc 20 mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1Pantin 20Pantoprazole sodium 20 mg delayed release tablets
2Piperacillin sodium and Tazobactam sodiumPiperacillin sodium 2 g + Tazobactam sodium 0.25 g
3PlasepClopidogrel 75 mg tablets
4Podoxal 100Cefpodoxime proxetil 100 mg tablets
5Podoxal 200Cefpodoxime proxetil 200 mg tablets
6Piperacillin sodium and Tazobactam sodiumPiperacillin sodium 2 g + Tazobactam sodium 0.25 g
7PaclitaxelPaclitaxel Solution for Injection 300 mg/50 mL
8PAMERA 40Adalimumab Solution for injection of 40 mg/0.8 mL
9Pifeltro 100Doravirine Film coated tablets 100mg
10PlatifirstCisplatin Solution 50mg/50ml
11Pulcet 40Pantoprazole Enteric coated tablets 40mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1QUITIDE 200Quetiapine Fumarate Film-coated tablets 200 mg
2QUITIDE 300Quetiapine Fumarate Film coated tablets 300 mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1RedmentinAmoxicillin 500 mg + Potassium clavulanate 125 mg
2Rispitas 1Risperidone 1 mg tablets
3RESICALM 2Risperidone Film-coated Tablets of 2 mg
4ROTAVIRUS VACCINE, LIVE ATTENUATEDLive Attenuated Rotavirus Lyophilized mass of Rotavirus serotypes G1, G2, G3, G4 and G9 ≥105.6 of each serotype
5ROTAVIRUS VACCINE, LIVE ATTENUATEDLive Attenuated Rotavirus Lyophilized mass of Rotavirus serotypes G1, G2, G3, G4 and G9 ≥105.6 of each serotype
6RUISUFA ®10Rosuvastatin Calcium 10mg Film Coated tablet 10mg
7RUISUFA® 5Rosuvastatin Calcium 5mg Film Coated tablet 5mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1Sanfur - 1500Cefuroxime 1500 mg powder for injection
2Sanfur - 750Cefuroxime 750 mg powder for injection
3.Sitagliptin 100 mg TabletsSitagliptin 100 mg Tablets
4Sodium ChlorideSodium Chloride 0.9% w/v intravenous infusion
5.Sitagliptin 50 mg TabletsSitagliptin 50 mg Tablets
6.Sitagliptin 50-100mg TabletsSitagliptin 50-100mg Tablets
7SolfesireSolifenacin succinate 5 mg film coated tablets
8SolfesireSolifenacin succinate 10 mg film coated tablets
9SITAPRIL M 50/1000Sitagliptin + Metformin Hydrochloride Film-Coated Tablets 50mg + 1000mg
10SITAPRIL M 50/500Sitagliptin + Metformin Hydrochloride Film-Coated Tablets 50mg + 500mg
11SURAXIMCefixime Trihydrate Capsule of 400 mg
12SwaziAzithromycin dihydrate Film coated tablet 250mg
13SwaziAzithromycin dihydrate Film coated tablet 500mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1TacrocordTacrolimus 5 mg capsules
2TacrocordTacrolimus 1 mg capsules
3TacrocordTacrolimus 0.5 mg capsules
4Tranexamic acidTranexamic acid 500 mg/5 mL injection
5TalzennaTalazoparib Hard gelatin capsule 1 mg
6TalzennaTalazoparib Hard gelatin capsule 0.5mg
7Tenofovir AlafenamideTenofovir Alafenamide Fumarate Film coated tablets 25mg
8TIMATETimolol Maleate Eye drops of 0.5% w/v
9TURBOVAS-10Rosuvastatin Calcium Film coated Tablets 10mg
10Turbovas-20Rosuvastatin Calcium Film coated Tablets 20mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1UNOAMOXI 250Amoxicillin Tablet 250mg
2URYSOREN-10Solifenacin Succinate Film coated Tablets of 10 mg
3URYSOREN-5Solifenacin Succinate Film coated Tablets of 5 mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1VIZIMPRODacomitinib Monohydrate Film coated tablets 15mg
2VIZIMPRODacomitinib Monohydrate Film coated tablets 30mg
3VIZIMPRODacomitinib Monohydrate Film coated tablets 45mg
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1Zofarin 1Warfarin Sodium 1 mg tablets
2Zofarin 2.5Warfarin Sodium 2.5 mg tablets
3Zofarin 2.5Warfarin Sodium 2 mg tablets
4Zofarin 3Warfarin Sodium 3 mg tablets
5Zofarin 5Warfarin Sodium 5 mg tablets
6ZELBEEN 150Capecitabine Film coated tablets of 150 mg
7ZELBEEN 500Capecitabine Film coated tablets of 500 mg
8ZENTHRO-500Azithromycin Dihydrate Hard Gelatin Capsules of 500 mg
9ZOPIMAC 3Eszopiclone Film coated Tablets of 3 mg

Tanzania Public Assessment Reports (TPAR)

TPAR is a summary of assessment report developed by TMDA following evaluation of medicinal product dossier submitted in support of application of marketing authorisation. TPARs are published in order to make the general public and all our stakeholders aware of the evaluation processes and grounds for approving registration of medicinal products.


1.PUBLIC ASSESSMENT REPORT FOR CDTEL-H® (TERMISATARTAN 40 MG AND HYDROCHLOROTHIAZIDE 12.5 MG) TABLETS, Version number 0.1 March, 2021Download
2.PUBLIC ASSESSMENT REPORT FOR MYDEKLATM 60 (DACLATASVIR 60 MG) FILM COATED TABLETS, Version number 1, 23 March, 2022 Download
3.PUBLIC ASSESSMENT REPORT FOR DURART 600 (DANURAVIR ETHANOLATE EQUIVALENT TO DARUNAVIR 600 MG) FILM COATED TABLETS, Version number 0.1 March, 2022Download
4.PUBLIC ASSESSMENT REPORT FOR DURART 800 (DANURAVIR ETHANOLATE EQUIVALENT TO DARUNAVIR 800 MG) FILM COATED TABLETS, Version number 1 March, 2021Download
5.PUBLIC ASSESSMENT REPORT FOR NEOGLIP (SITAGLIPTIN + METFORMIN 50/1000 MG) TABLETS, Version number 0.1, March, 2022Download
6.PUBLIC ASSESSMENT REPORT FOR PRILIGY (DAPOXETINE HYDROCHLORIDE 60 MG) FILM COATED TABLETS, Version number 1 March, 2022Download
7.PUBLIC ASSESSMENT REPORT FOR LAMITAR AM (ARTEMETHER 20 MG + LUMEFANTRINE 120 MG) FILM COATED TABLETS, ersion number 01 March, 2022Download
8.PUBLIC ASSESSMENT REPORT FOR METAPROL (METOPROLOL TARTRATE 50 MG) FILM COATED TABLETS, Version number 0.1 March, 2022 Download
9.PUBLIC ASSESSMENT REPORT FOR INBEC TM (600 MG ABACAVIR (AS SULPHATE) + 50 MG DOLUTEGRAVIR (AS SODIUM)+ 300 MG LAMIVUDINE) FILM COATED TABLETS, Version number 0.1 March 2022 Download
10.PUBLIC ASSESSMENT REPORT FOR SPINO-25 (SPIRONOLACTONE 250 MG) FILM COATED TABLETS, Version number 0.1, March, 2022Download
11.PUBLIC ASSESSMENT REPORT FOR METHOREX (METHOTREXATE DISODIUM EQUIVALENT TO METHOTREXATE 2.5 MG) TABLETS, Version number 0.1 March 2022Download
12.PUBLIC ASSESSMENT REPORT FOR AZUNATE (ARTESUNATE 60 MG) POWDER FOR INJECTION, Version number 0.1, March 2022 Download
13.PUBLIC ASSESSMENT REPORT FOR PEG NEUKINE (PEGFILGRASTIM 6 MG/ 0.6 ML) SOLUTION FOR INJECTION, Version number 0.1 March 2022 Download
14.PUBLIC ASSESSMENT REPORT FOR MF-DAY ER 750 (METFORMIN HYDROCHLORIDE 750 MG) EXTENDED-RELEASE TABLETS, Version number 0.1, March, 2022 Download
15.PUBLIC ASSESSMENT REPORT FOR MF-DAY ER 500 (METFORMIN HYDROCHLORIDE 500 MG) EXTENDED-RELEASE TABLETS, Version number 0.1 March 2022Download
16.PUBLIC ASSESSMENT REPORT FOR GLUMAC® (ARTEMETHER 20MG AND LUMEFANTRINE 120MG) TABLETS, Version number 01 March, 2022Download
17.PUBLIC ASSESSMENT REPORT FOR AMLOVIE 10 (AMLODIPINE 10MG) TABLETS, Version number 01, April, 2022Download
18.PUBLIC ASSESSMENT REPORT FOR ARTEFAN 60/360 (ARTEMETHER 60 MG AND LUMEFANTRINE 360 MG) TABLETS, Version number 01, April, 2022Download
19.PUBLIC ASSESSMENT REPORT FOR TURBOVAS-20 (20 MG ROSUVASTATIN (AS CALCIUM)) FILM COATED TABLETS, Version number 01 April, 2022Download
20.PUBLIC ASSESSMENT REPORT FOR MYHEP 400 , Version number 01 April, 2022Download
21.PUBLIC ASSESSMENT REPORT FOR ARTEFAN 80/480 (ARTEMETHER 80 MG AND LUMEFANTRINE 480 MG) TABLETS, Version number 01, April, 2022Download
22.PUBLIC ASSESSMENT REPORT FOR LARIACT 20 MG/120 MG (ARTMETHER 20 MG AND LUMEFANTRINE 120 MG) TABLETS, Version number 01, April, 2022Download
23.PUBLIC ASSESSMENT REPORT FOR CO-ANGINET 160/25 (VALSARTAN 160 MG/HYDROCHLOROTHIAZIDE 25 MG) FILM COATED TABLETS, Version number 01, April, 2022Download
24.PUBLIC ASSESSMENT REPORT FOR CISTEEN (CISPLATIN 50MG/50ML) SOLUTION FOR INJECTION, Version number 01, April, 2022Download
25.PUBLIC ASSESSMENT REPORT FOR A-GLIP (SITAGLIPTIN PHOSPHATE MONOHYDRATE 50 mg) FILM COATED TABLETS, Version number 01, April, 2022Download
26.PUBLIC ASSESSMENT REPORT FOR BEVAMAB 400 (BEVACIZUMAB 400 MG/16 ML) CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION, Version number 01 April, 2022Download
27.PUBLIC ASSESSMENT REPORT FOR PACLITAXEL 300 MG/50 ML CONCENTRATE FOR SOLUTION FOR INJECTION, Version number 01 April, 2022Download
28.PUBLIC ASSESSMENT REPORT FOR TALZENNA (TALAZOPARIB 0.25 MG) CAPSULES, Version number 01 April, 2022Download
29.PUBLIC ASSESSMENT REPORT FOR CARFILNAT (CARFILZOMIB 60 MG/VIAL) FOR INJECTION, Version number 01 April, 2022Download
30.PUBLIC ASSESSMENT REPORT FOR AMLOVIE 5 (AMLODIPINE 5 MG) TABLETS, Version number 01 April, 2022Download
31.PUBLIC ASSESSMENT REPORT FOR TECENTRIQ (ATEXOLIZUMAB 1200 MG/20 ML) CONCENTRATE FOR SOLUTION FOR INFUSION, Version number 01 April, 2022Download
32.PUBLIC ASSESSMENT REPORT FOR PACLITAXEL 100 MG/16.7 ML CONCENTRATE FOR SOLUTION FOR INJECTION, Version number 01 April, 2022Download
33.PUBLIC ASSESSMENT REPORT FOR BEVAMAB 100 (BEVACIZUMAB 100 MG/ 4 ML) CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION, Version number 01 April, 2022Download
34.PUBLIC ASSESSMENT REPORT FOR 4-EPEEDO-10 (EPIRUBICIN HYDROCHLORIDE 10MG/VIAL) LYOPHILIZED INJECTION, Version number 01 April, 2022Download
35.PUBLIC ASSESSMENT REPORT FOR GEMCITABINE HYDROCHLORIDE (200 MG GEMCITABINE (AS HYDROCHLORIDE)) LYOPHILIZED POWDER FOR INJECTION, Version number 01 April, 2022Download
36.PUBLIC ASSESSMENT REPORT FOR LARIACT (ARTMETHER 20 MG AND LUMEFANTRINE 120 MG) DISPERSIBLE TABLETS, Version number 01 April, 2022Download
37.PUBLIC ASSESSMENT REPORT FOR TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25 MG) FILM COATEDTABLETS, Version number 01 April, 2022Download
38.PUBLIC ASSESSMENT REPORT FOR RUISUFA® 5 MG (ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 5 MG) FILM COATED TABLETS, Version number 01 April, 2022Download
39.PUBLIC ASSESSMENT REPORT FOR RUISUFA® 10 MG (ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 10MG) FILM COATED TABLETS, Version number 01 April, 2022Download
40.PUBLIC ASSESSMENT REPORT FOR VIZIMPRO (DACOMITINIB MONOHYDRATE 45 MG) IMMEDIATE RELEASE FILM COATED TABLETS , Version number 01 April, 2022Download
41.PUBLIC ASSESSMENT REPORT FOR PERJETA (PERTUZUMAB 420 MG/ 14 ML) CONCENTRATE FOR SOLUTION FOR INFUSION, Version number 01 April, 2022Download
42.PUBLIC ASSESSMENT REPORT FOR TURBOVAS-10 (10 MG ROSUVASTATIN (AS CALCIUM)) FILM COATED TABLETS, Version number 01 April, 2022Download
43.PUBLIC ASSESSMENT REPORT FOR PLATIFIRST 50 MG/50 ML (CISPLATIN 50MG/50ML) INJECTION, Version number 01 April, 2022Download
44.PUBLIC ASSESSMENT REPORT FOR TENGLYN 20 MG (TENELIGLIPTIN HEMIPENTAHYDROBROMIDE HYDRATE EQUIVALENT TO TENELIGLIPTIN 20 MG) FILM COATED TABLETS, Version number 01 April, 2022Download
45.PUBLIC ASSESSMENT REPORT FOR VIZIMPRO (DACOMITINIB MONOHYDRATE 15 MG) IMMEDIATE RELEASE FILM COATED TABLETS , Version number 01 April, 2022Download
46.PUBLIC ASSESSMENT REPORT FOR CO-ANGINET 160/12.5 (VALSARTAN 160 MG/HYDROCHLOROTHIAZIDE 12.5 MG) FILM COATED TABLETS, Version number 01 April, 2022Download
47.PUBLIC ASSESSMENT REPORT FOR TALZENNA (TALAZOPARIB 1 MG) HARD GELATIN CAPSULES, Version number 01 April, 2022Download
48.PUBLIC ASSESSMENT REPORT FOR VIZIMPRO (DACOMITINIB MONOHYDRATE 30 MG) IMMEDIATE RELEASE FILM COATED TABLETS , Version number 01 April, 2022Download
49.PUBLIC ASSESSMENT REPORT FOR NORMOPRESS (LOSARTAN POTASSIUM 50 MG) TABLETS, Version number 01 April, 2022Download
50.PUBLIC ASSESSMENT REPORT FOR PLATIFIRST 10MG/10ML (CISPLATIN1MG/ML) SOLUTION FOR INJECTION, Version number 01 April, 2022Download
51.PUBLIC ASSESSMENT REPORT FOR DELSTRIGO™ 100 MG/300MG/300MG (DORAVIRINE 100 MG, LAMIVUDINE 300 MG AND TENOFOVIR DISOPROXIL FUMARATE 300 MG) FILM COATED TABLETS, Version number 01 April, 2022Download
52.PUBLIC ASSESSMENT REPORT FOR INTAS (BICALUTAMIDE 50MG) FILM COATED TABLETS, Version number 01 April, 2022Download