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 | |
| 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 | |
| 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 | |
| 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 | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Elosone | Mometasone furoate 0.1%w/w | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Fixet 200 | Cefixime 200 mg tablets | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 591 | 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 | |
| SUMMARY OF PRODUCT CHARACTERISTICS | |||
|---|---|---|---|
| S/N | Product Name | Generic name | |
| 1 | Redmentin | Amoxicillin 500 mg + Potassium clavulanate 125 mg | |
| 2 | Piperacillin sodium and Tazobactam sodium | Piperacillin sodium 2 g + Tazobactam sodium 0.25 g | |
| 3 | Rispitas 1 | Risperidone 1 mg tablets | |
| 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 | |
| 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 | |
| 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 | |
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.