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 Tablets | Alfuzosin 10 mg Tablets | |
| 2 | Alrinast | Desloratadine 5 mg film coated tablets | |
| 3 | Amoxicillin | Amoxicillin 500 mg capsule | |
| 4 | Amoxicillin | Amoxicillin 250 mg capsule | |
| 5. | Atenolol 100 mg Tablets | Atenolol 100 mg Tablets | |
| 6 | Atorkey | Atorvastatin 20 mg tablets | |
| 7. | Atorvastatin 10 mg Tablets | Atorvastatin 10 mg Tablets | |
| 8. | Atorvastatin 20 mg Tablets | Atorvastatin 20 mg Tablets | |
| 9 | A – GLIP | Sitagliptin Phosphate Monohydrate Tablets 50mg | |
| 10 | ALCEF 500 | Ceftriaxone Sodium Dry Powder for injection 500mg | |
| 11 | ALCEF-SB | Ceftriaxone Sodium & Sulbactam Dry Powder for Injection 1 g+0.5 g | |
| 12 | Amlovie 10 | Amlodopine Tablet 10mg | |
| 13 | AMLOVIE 5 | Amlodopine Tablet 5mg | |
| 14 | Atoneura 40 | Atomoxetine Hydrochloride Hard gelatin Capsules 40mg | |
| 15 | AUROPODOX 40 | Cefpodoxime Proxetil Powder for Oral Suspension of 40 mg/5 mL | |
| 16 | AXACIP | Ciprofloxacin Solution for Infusion 200mg/100 ml | |
| 17 | AXAFLOX-I | Ofloxacin Opthalmic solution of 0.3% w/v | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1. | Bisoprolol 10 mg Tablets | Bisoprolol 10 mg Tablets | |
| 2. | Bisoprolol 5 mg Tablets | Bisoprolol 5 mg Tablets | |
| 3 | Bortebin | Bortezomib 3.5 mg powder for solution for injection | |
| 4 | Bevamab 100 | Bevacizumab Solution for infusion 100mg/4mL | |
| 5 | BEXITROL-F 25/125 | Salmeterol Xinafoate + Fluticasone Propionate Aerosol Suspension inhaler of 25 µg + 125 µg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Calcium folinate | Calcium folinate 50 mg/5 mL solution for injection | |
| 2 | Candivor | Voriconazole 200 mg/vial injection | |
| 3 | Carfilnat | Carfilzomib 60 mg/vial lyophilized powder for injection | |
| 4 | Cetafor | Ceftriaxone 500 mg powder for injection | |
| 5 | Cetafor | Ceftriaxone 1000 mg powder for injection | |
| 6 | Chlorphenamine | Chlorphenamine 5 mg tablets | |
| 7 | Clotripin | Clotrimazole 1% w/w cream | |
| 8 | Cornizole denta | Metronidazole 1% w/w gel | |
| 9 | CACHEWORM | Mebendazole Oral Suspension of 100 mg/5mL | |
| 10 | CACHEWORM | Mebendazole Uncoated tablet of 100 mg | |
| 11 | Cardiolek - 320 | Iodixanol Solution for Injection 320mg | |
| 12 | CARFILNAT | Carfilozimab Lyophilized powder for injection each 1 ml contains 2mg of Carfilozimab | |
| 13 | CEFUTIL | Cefuroxime Axetil Film coated tablets of 500 mg | |
| 14 | CEPHAXIM | Cefalexin Monohydrate Hard gelatin capsules 250 mg | |
| 15 | CHLORURE DE SODIUM 0.9% UNIMED | Sodium Chloride Solution for infusion 0.9% w/v | |
| 16 | CIPROBID 500 | Ciprofloxacin Hydrochloride Film coated Tablets 500 mg | |
| 17 | Cisteen Injection | Cisplatin Solution for Injection 50mg/50ml | |
| 18 | COMFORA | Pentosan Polysulfate Sodium | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Dacarbazine | Dacarbazine 200 mg/vial injection | |
| 2 | Dapzin-10 | Dapagliflozin 10 mg tablets | |
| 3 | Dapzin-5 | Dapagliflozin 5 mg tablets | |
| 4 | Dermicolon | Triamcinolone acetonide 0.1% w/w ointment | |
| 5 | DAPOXEM 30 | Dapoxetine Hydrochloride Hard Gelatin Capsule 100mg | |
| 6 | DAPOXEM 60 | Dapoxetine Hydrochloride Film coated tablets 60 mg | |
| 7 | DAPTOMYCIN | Daptomycin Lyophilized powder for reconstitution for injection 500 mg | |
| 8 | DelstrigoTM | Doravirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablet 100mg+300mg+300mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Elosone | Mometasone furoate 0.1%w/w | |
| 2 | Enoxamed | Enoxaparin Sodium Solution for Injection in Pre filled Syringes 4000 IU/0.4 mL | |
| 3 | Enoxamed | Enoxaparin Sodium Solution for Injection in Pre filled Syringes 6000 IU/0.6 mL | |
| 4 | Enoxamed | Enoxaparin Sodium Solution for Injection in Pre filled Syringes 2000 IU/0.2 mL | |
| 5 | Enoxamed | Enoxaparin Sodium Solution for Injection in Pre filled Syringes 8000 IU/0.8 mL | |
| 6 | Enzystal P | Pancreatin "Enteric Coated Tablets Amylase activity 4200 Ph. Eur. Units Lipase activity 3500 Ph. Eur. Units Protease activity 250 Ph. Eur. units " | |
| 7 | EPSYLAM DT 100 | Lamotrigine Dispersible Tablets 100mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Fixet 200 | Cefixime 200 mg tablets | |
| 2 | FAROGLIP S 50 | Sitagliptin Phosphate Monohydrate Film Coated Tablet 50mg | |
| 3 | Fluzyn20 | Fluoxetine Hydrochloride Hard Gelatin Capsules 20mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1. | Gliclazide 30 mg Tablets | Gliclazide 30 mg Tablets | |
| 2. | Gliclazide 30 mg Tablets | Gliclazide 30 mg Tablets | |
| 3. | Gliclazide 60 mg Tablets | Gliclazide 60 mg Tablet | |
| 4. | Glimepiride 1 mg Tablets | Glimepiride 1 mg Tablets | |
| 5. | Glimepiride 2 mg Tablets | Glimepiride 2 mg Tablets | |
| 6. | Glimepiride 2 mg Tablets | Glimepiride 2 mg Tablets | |
| 7. | Glimepiride 3 mg Tablets | Glimepiride 3 mg Tablets | |
| 8. | Glimepiride 3 mg Tablets | Glimepiride 3 mg Tablets | |
| 9. | Glimepiride 4 mg Tablets | Glimepiride 4 mg Tablets | |
| 10. | Glimepiride 4 mg Tablets | Glimepiride 4 mg Tablets | |
| 11. | Glimepiride 4 mg Tablets | Glimepiride 4 mg Tablets | |
| 12 | G-CEFTRIA | Ceftriaxone Sodium Sterile Powder for Injection 1g | |
| 13 | Gemcitabine | Gemcitabine hydrochloride Lyophilized Powder for Injection 200 mg | |
| 14 | GENCEF-1 | Ceftriaxone Sodium Dry Powder 1000mg | |
| 15 | GENLEX 125MG/5ML | Cephalexin Monohydrate Dry Powder for Oral Suspension 125mg | |
| 16 | Gentamicin Sulfate | Gentamicin Sulfate Solution for injection 80mg/2mL | |
| 17 | GMYCIN 80 | Gentamicin Sulfate Solution for injection 80 mg/2mL | |
| 18 | GMYCIN 80 | Gentamicin 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 ml | Human Insulin 3 ml | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1. | Insulin Detemir | Insulin Detemir | |
| 2. | Insulin Glargine | Insulin Glargine | |
| 3 | Intaflam | Ibuprofen 400 mg + Paracetamol 325 mg | |
| 4 | INNOFIX 400 | Cefixime Trihydrate Hard Gelatin Capsules of 400 mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Klar | Clarithromycin 500 mg tablets | |
| 2 | Klar | Clarithromycin 250 mg tablets | |
| 3 | KLABIL™ BID | Amoxicillin 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 | |
| 1 | Letrozole Denk 2.5 | Letrozole 2.5 mg | |
| 2 | Levorest | Levonogestrel 0.15 mg + Ethynylestradiol 0.03 mg | |
| 3 | Lulizol cream | Luliconazole 1%w/w cream | |
| 4 | Lamivudine/Nevirapine/Zidovudine | Lamivudine/Nevirapine/Zidovudine Tablet 150 mg+200 mg+300 mg | |
| 5 | Lariact | Artemether + Lumefantrine Dispersible Tablets 20mg+120mg | |
| 6 | LEVEGET TM | Levetiracetam Film coated tablet 250mg | |
| 7 | LEVEGET TM | Levetiracetam Film coated tablet 500mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | S/N | Product Name | Generic name |
|---|---|---|---|
| 1 | Maxalyte | Oral Rehydration Salts | |
| 2 | Meloxicam | Meloxicam 15 mg tablets | |
| 3 | Meloxicam | Meloxicam 7.5 mg tablets | |
| 4. | Metformin Hydrochloride 1000 mg Tablets | Metformin Hydrochloride 1000 mg Tablets | |
| 5. | Metformin Hydrochloride 1000 mg Tablets | Metformin Hydrochloride 1000 mg Tablets | |
| 6. | Metformin Hydrochloride 500 mg Tablets XR | Metformin Hydrochloride 500 mg Tablets XR | |
| 7. | Metformin Hydrochloride 500 mg Tablets | Metformin Hydrochloride 500 mg Tablets | |
| 8. | Metformin Hydrochloride 500 mg Tablets | Metformin Hydrochloride 500 mg Tablets | |
| 9. | Metformin Hydrochloride 500 mg Tablets | Metformin Hydrochloride 500 mg Tablets | |
| 10. | Metformin Hydrochloride 500 mg Tablets | Metformin Hydrochloride 500 mg Tablets | |
| 11. | Metformin Hydrochloride 500 mg Tablets XR | Metformin Hydrochloride 500 mg Tablets XR | |
| 12. | Metformin Hydrochloride 750 mg Tablest | Metformin Hydrochloride 750 mg Tablest | |
| 13. | Metformin Hydrochloride 750 mg Tablets | Metformin Hydrochloride 750 mg Tablets | |
| 14. | Metformin Hydrochloride 750 mg Tablets XR | Metformin Hydrochloride 750 mg Tablets XR | |
| 15. | Metformin Hydrochloride 850 mg Tablets | Metformin Hydrochloride 850 mg Tablets | |
| 16. | Metformin Hydrochloride 850 mg Tablets | Metformin Hydrochloride 850 mg Tablet | |
| 17. | Metformin Hydrochloride 850 mg Tablets | Metformin Hydrochloride 850 mg Tablets | |
| 18. | Metformin Hydrochloride 850 mg Tablets | Metformin Hydrochloride 850 mg Tablets | |
| 19. | Metformini Hydrochloride 500 mg Tablets | Metformini Hydrochloride 500 mg Tablets | |
| 20 | Meto | Metoclopromide 10 mg tablets | |
| 21 | Mphetas-500 | Mycophenolate Mofetil 500 mgTablets | |
| 22 | Myhep | Sofosbuvir 400 mg tablets | |
| 23 | Mebaal ODS 1500 | Mecobalamin Orally disintegrating strips of 1500 mcg | |
| 24 | MOFECON-S 180 | Mycophenolic Acid (as Mycophenolate Sodium) Mycophenolic Acid 180 mg | |
| 25 | MOFECON-S 360 | Mycophenolic Acid (as Mycophenolate Sodium) Mycophenolic Acid 360 mg | |
| 26 | MOFLOX | Moxifloxacin Hydrochloride Film coated tablets of 400 mg | |
| 27 | MOXIGET IV | MOXIFLOXACIN HYDROCHLORIDE Solution for infusion 400 mg/ 250 mL | |
| 28 | Mycept –S 180 | Mycophenolate sodium Delayed Release Tablet 180mg | |
| 29 | MYCOPHENOLIC ACID | Mycophenolate Sodium Gastro resistant tablets 360 mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Novator 500 | Deferiprone Hard gelatin Capsules 500mg | |
| 2 | NS | Sodium Chloride Intravenous Infusion 0.9% | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Ondansetron orodispersible tablets | Ondansetron orodispersible 8 mg tablets | |
| 2 | Oratane 40 | Isotretinoin 40 mg soft gelatin capsules | |
| 3 | ORILAM ODT 100 | Lamotrigine Disintegrating Tablets 100mg | |
| 4 | ORILAM ODT 50 | Lamotrigine Disintegrating Tablets 50mg | |
| 5 | OZINC-DT | Zinc Sulfate Monohydrate Zinc Sulfate Monohydrate Equivalent to Zinc 20 mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Pantin 20 | Pantoprazole sodium 20 mg delayed release tablets | |
| 2 | Piperacillin sodium and Tazobactam sodium | Piperacillin sodium 2 g + Tazobactam sodium 0.25 g | |
| 3 | Plasep | Clopidogrel 75 mg tablets | |
| 4 | Podoxal 100 | Cefpodoxime proxetil 100 mg tablets | |
| 5 | Podoxal 200 | Cefpodoxime proxetil 200 mg tablets | |
| 6 | Piperacillin sodium and Tazobactam sodium | Piperacillin sodium 2 g + Tazobactam sodium 0.25 g | |
| 7 | Paclitaxel | Paclitaxel Solution for Injection 300 mg/50 mL | |
| 8 | PAMERA 40 | Adalimumab Solution for injection of 40 mg/0.8 mL | |
| 9 | Pifeltro 100 | Doravirine Film coated tablets 100mg | |
| 10 | Platifirst | Cisplatin Solution 50mg/50ml | |
| 11 | Pulcet 40 | Pantoprazole Enteric coated tablets 40mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | QUITIDE 200 | Quetiapine Fumarate Film-coated tablets 200 mg | |
| 2 | QUITIDE 300 | Quetiapine Fumarate Film coated tablets 300 mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Redmentin | Amoxicillin 500 mg + Potassium clavulanate 125 mg | |
| 2 | Rispitas 1 | Risperidone 1 mg tablets | |
| 3 | RESICALM 2 | Risperidone Film-coated Tablets of 2 mg | |
| 4 | ROTAVIRUS VACCINE, LIVE ATTENUATED | Live Attenuated Rotavirus Lyophilized mass of Rotavirus serotypes G1, G2, G3, G4 and G9 ≥105.6 of each serotype | |
| 5 | ROTAVIRUS VACCINE, LIVE ATTENUATED | Live Attenuated Rotavirus Lyophilized mass of Rotavirus serotypes G1, G2, G3, G4 and G9 ≥105.6 of each serotype | |
| 6 | RUISUFA ®10 | Rosuvastatin Calcium 10mg Film Coated tablet 10mg | |
| 7 | RUISUFA® 5 | Rosuvastatin Calcium 5mg Film Coated tablet 5mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Sanfur - 1500 | Cefuroxime 1500 mg powder for injection | |
| 2 | Sanfur - 750 | Cefuroxime 750 mg powder for injection | |
| 3. | Sitagliptin 100 mg Tablets | Sitagliptin 100 mg Tablets | |
| 4 | Sodium Chloride | Sodium Chloride 0.9% w/v intravenous infusion | |
| 5. | Sitagliptin 50 mg Tablets | Sitagliptin 50 mg Tablets | |
| 6. | Sitagliptin 50-100mg Tablets | Sitagliptin 50-100mg Tablets | |
| 7 | Solfesire | Solifenacin succinate 5 mg film coated tablets | |
| 8 | Solfesire | Solifenacin succinate 10 mg film coated tablets | |
| 9 | SITAPRIL M 50/1000 | Sitagliptin + Metformin Hydrochloride Film-Coated Tablets 50mg + 1000mg | |
| 10 | SITAPRIL M 50/500 | Sitagliptin + Metformin Hydrochloride Film-Coated Tablets 50mg + 500mg | |
| 11 | SURAXIM | Cefixime Trihydrate Capsule of 400 mg | |
| 12 | Swazi | Azithromycin dihydrate Film coated tablet 250mg | |
| 13 | Swazi | Azithromycin dihydrate Film coated tablet 500mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Tacrocord | Tacrolimus 5 mg capsules | |
| 2 | Tacrocord | Tacrolimus 1 mg capsules | |
| 3 | Tacrocord | Tacrolimus 0.5 mg capsules | |
| 4 | Tranexamic acid | Tranexamic acid 500 mg/5 mL injection | |
| 5 | Talzenna | Talazoparib Hard gelatin capsule 1 mg | |
| 6 | Talzenna | Talazoparib Hard gelatin capsule 0.5mg | |
| 7 | Tenofovir Alafenamide | Tenofovir Alafenamide Fumarate Film coated tablets 25mg | |
| 8 | TIMATE | Timolol Maleate Eye drops of 0.5% w/v | |
| 9 | TURBOVAS-10 | Rosuvastatin Calcium Film coated Tablets 10mg | |
| 10 | Turbovas-20 | Rosuvastatin Calcium Film coated Tablets 20mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | UNOAMOXI 250 | Amoxicillin Tablet 250mg | |
| 2 | URYSOREN-10 | Solifenacin Succinate Film coated Tablets of 10 mg | |
| 3 | URYSOREN-5 | Solifenacin Succinate Film coated Tablets of 5 mg | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Zofarin 1 | Warfarin Sodium 1 mg tablets | |
| 2 | Zofarin 2.5 | Warfarin Sodium 2.5 mg tablets | |
| 3 | Zofarin 2.5 | Warfarin Sodium 2 mg tablets | |
| 4 | Zofarin 3 | Warfarin Sodium 3 mg tablets | |
| 5 | Zofarin 5 | Warfarin Sodium 5 mg tablets | |
| 6 | ZELBEEN 150 | Capecitabine Film coated tablets of 150 mg | |
| 7 | ZELBEEN 500 | Capecitabine Film coated tablets of 500 mg | |
| 8 | ZENTHRO-500 | Azithromycin Dihydrate Hard Gelatin Capsules of 500 mg | |
| 9 | ZOPIMAC 3 | Eszopiclone 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, 2021 | Download |
| 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, 2022 | Download |
| 4. | PUBLIC ASSESSMENT REPORT FOR DURART 800 (DANURAVIR ETHANOLATE EQUIVALENT TO DARUNAVIR 800 MG) FILM COATED TABLETS, Version number 1 March, 2021 | Download |
| 5. | PUBLIC ASSESSMENT REPORT FOR NEOGLIP (SITAGLIPTIN + METFORMIN 50/1000 MG) TABLETS, Version number 0.1, March, 2022 | Download |
| 6. | PUBLIC ASSESSMENT REPORT FOR PRILIGY (DAPOXETINE HYDROCHLORIDE 60 MG) FILM COATED TABLETS, Version number 1 March, 2022 | Download |
| 7. | PUBLIC ASSESSMENT REPORT FOR LAMITAR AM (ARTEMETHER 20 MG + LUMEFANTRINE 120 MG) FILM COATED TABLETS, ersion number 01 March, 2022 | Download |
| 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, 2022 | Download |
| 11. | PUBLIC ASSESSMENT REPORT FOR METHOREX (METHOTREXATE DISODIUM EQUIVALENT TO METHOTREXATE 2.5 MG) TABLETS, Version number 0.1 March 2022 | Download |
| 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 2022 | Download |
| 16. | PUBLIC ASSESSMENT REPORT FOR GLUMAC® (ARTEMETHER 20MG AND LUMEFANTRINE 120MG) TABLETS, Version number 01 March, 2022 | Download |
| 17. | PUBLIC ASSESSMENT REPORT FOR AMLOVIE 10 (AMLODIPINE 10MG) TABLETS, Version number 01, April, 2022 | Download |
| 18. | PUBLIC ASSESSMENT REPORT FOR ARTEFAN 60/360 (ARTEMETHER 60 MG AND LUMEFANTRINE 360 MG) TABLETS, Version number 01, April, 2022 | Download |
| 19. | PUBLIC ASSESSMENT REPORT FOR TURBOVAS-20 (20 MG ROSUVASTATIN (AS CALCIUM)) FILM COATED TABLETS, Version number 01 April, 2022 | Download |
| 20. | PUBLIC ASSESSMENT REPORT FOR MYHEP 400 , Version number 01 April, 2022 | Download |
| 21. | PUBLIC ASSESSMENT REPORT FOR ARTEFAN 80/480 (ARTEMETHER 80 MG AND LUMEFANTRINE 480 MG) TABLETS, Version number 01, April, 2022 | Download |
| 22. | PUBLIC ASSESSMENT REPORT FOR LARIACT 20 MG/120 MG (ARTMETHER 20 MG AND LUMEFANTRINE 120 MG) TABLETS, Version number 01, April, 2022 | Download |
| 23. | PUBLIC ASSESSMENT REPORT FOR CO-ANGINET 160/25 (VALSARTAN 160 MG/HYDROCHLOROTHIAZIDE 25 MG) FILM COATED TABLETS, Version number 01, April, 2022 | Download |
| 24. | PUBLIC ASSESSMENT REPORT FOR CISTEEN (CISPLATIN 50MG/50ML) SOLUTION FOR INJECTION, Version number 01, April, 2022 | Download |
| 25. | PUBLIC ASSESSMENT REPORT FOR A-GLIP (SITAGLIPTIN PHOSPHATE MONOHYDRATE 50 mg) FILM COATED TABLETS, Version number 01, April, 2022 | Download |
| 26. | PUBLIC ASSESSMENT REPORT FOR BEVAMAB 400 (BEVACIZUMAB 400 MG/16 ML) CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION, Version number 01 April, 2022 | Download |
| 27. | PUBLIC ASSESSMENT REPORT FOR PACLITAXEL 300 MG/50 ML CONCENTRATE FOR SOLUTION FOR INJECTION, Version number 01 April, 2022 | Download |
| 28. | PUBLIC ASSESSMENT REPORT FOR TALZENNA (TALAZOPARIB 0.25 MG) CAPSULES, Version number 01 April, 2022 | Download |
| 29. | PUBLIC ASSESSMENT REPORT FOR CARFILNAT (CARFILZOMIB 60 MG/VIAL) FOR INJECTION, Version number 01 April, 2022 | Download |
| 30. | PUBLIC ASSESSMENT REPORT FOR AMLOVIE 5 (AMLODIPINE 5 MG) TABLETS, Version number 01 April, 2022 | Download |
| 31. | PUBLIC ASSESSMENT REPORT FOR TECENTRIQ (ATEXOLIZUMAB 1200 MG/20 ML) CONCENTRATE FOR SOLUTION FOR INFUSION, Version number 01 April, 2022 | Download |
| 32. | PUBLIC ASSESSMENT REPORT FOR PACLITAXEL 100 MG/16.7 ML CONCENTRATE FOR SOLUTION FOR INJECTION, Version number 01 April, 2022 | Download |
| 33. | PUBLIC ASSESSMENT REPORT FOR BEVAMAB 100 (BEVACIZUMAB 100 MG/ 4 ML) CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION, Version number 01 April, 2022 | Download |
| 34. | PUBLIC ASSESSMENT REPORT FOR 4-EPEEDO-10 (EPIRUBICIN HYDROCHLORIDE 10MG/VIAL) LYOPHILIZED INJECTION, Version number 01 April, 2022 | Download |
| 35. | PUBLIC ASSESSMENT REPORT FOR GEMCITABINE HYDROCHLORIDE (200 MG GEMCITABINE (AS HYDROCHLORIDE)) LYOPHILIZED POWDER FOR INJECTION, Version number 01 April, 2022 | Download |
| 36. | PUBLIC ASSESSMENT REPORT FOR LARIACT (ARTMETHER 20 MG AND LUMEFANTRINE 120 MG) DISPERSIBLE TABLETS, Version number 01 April, 2022 | Download |
| 37. | PUBLIC ASSESSMENT REPORT FOR TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE FUMARATE EQUIVALENT TO TENOFOVIR ALAFENAMIDE 25 MG) FILM COATEDTABLETS, Version number 01 April, 2022 | Download |
| 38. | PUBLIC ASSESSMENT REPORT FOR RUISUFA® 5 MG (ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 5 MG) FILM COATED TABLETS, Version number 01 April, 2022 | Download |
| 39. | PUBLIC ASSESSMENT REPORT FOR RUISUFA® 10 MG (ROSUVASTATIN CALCIUM EQUIVALENT TO ROSUVASTATIN 10MG) FILM COATED TABLETS, Version number 01 April, 2022 | Download |
| 40. | PUBLIC ASSESSMENT REPORT FOR VIZIMPRO (DACOMITINIB MONOHYDRATE 45 MG) IMMEDIATE RELEASE FILM COATED TABLETS , Version number 01 April, 2022 | Download |
| 41. | PUBLIC ASSESSMENT REPORT FOR PERJETA (PERTUZUMAB 420 MG/ 14 ML) CONCENTRATE FOR SOLUTION FOR INFUSION, Version number 01 April, 2022 | Download |
| 42. | PUBLIC ASSESSMENT REPORT FOR TURBOVAS-10 (10 MG ROSUVASTATIN (AS CALCIUM)) FILM COATED TABLETS, Version number 01 April, 2022 | Download |
| 43. | PUBLIC ASSESSMENT REPORT FOR PLATIFIRST 50 MG/50 ML (CISPLATIN 50MG/50ML) INJECTION, Version number 01 April, 2022 | Download |
| 44. | PUBLIC ASSESSMENT REPORT FOR TENGLYN 20 MG (TENELIGLIPTIN HEMIPENTAHYDROBROMIDE HYDRATE EQUIVALENT TO TENELIGLIPTIN 20 MG) FILM COATED TABLETS, Version number 01 April, 2022 | Download |
| 45. | PUBLIC ASSESSMENT REPORT FOR VIZIMPRO (DACOMITINIB MONOHYDRATE 15 MG) IMMEDIATE RELEASE FILM COATED TABLETS , Version number 01 April, 2022 | Download |
| 46. | PUBLIC ASSESSMENT REPORT FOR CO-ANGINET 160/12.5 (VALSARTAN 160 MG/HYDROCHLOROTHIAZIDE 12.5 MG) FILM COATED TABLETS, Version number 01 April, 2022 | Download |
| 47. | PUBLIC ASSESSMENT REPORT FOR TALZENNA (TALAZOPARIB 1 MG) HARD GELATIN CAPSULES, Version number 01 April, 2022 | Download |
| 48. | PUBLIC ASSESSMENT REPORT FOR VIZIMPRO (DACOMITINIB MONOHYDRATE 30 MG) IMMEDIATE RELEASE FILM COATED TABLETS , Version number 01 April, 2022 | Download |
| 49. | PUBLIC ASSESSMENT REPORT FOR NORMOPRESS (LOSARTAN POTASSIUM 50 MG) TABLETS, Version number 01 April, 2022 | Download |
| 50. | PUBLIC ASSESSMENT REPORT FOR PLATIFIRST 10MG/10ML (CISPLATIN1MG/ML) SOLUTION FOR INJECTION, Version number 01 April, 2022 | Download |
| 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, 2022 | Download |
| 52. | PUBLIC ASSESSMENT REPORT FOR INTAS (BICALUTAMIDE 50MG) FILM COATED TABLETS, Version number 01 April, 2022 | Download |