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Approved Medicine Product Information


Summary of Products Characteristics

A Summary of Product Characteristics (SPCs) provides information about medicinal product’s properties and the conditions attached to its use including how it should be prescribed. It is used by healthcare professionals, such as doctors, nurses and pharmacists.

TMDA is currently publishing SPCs for selected groups of medicines including antihypertensive, antidiabetic, anticancer, innovator products, WHO Prequalified medicines and any registered new chemical entity in Tanzania.

The following table shows the Summary of Product Characteristics (SPCs):

SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Manuafacturer
1. Alfuzosin 10 mg Tablets Torrent Pharmaceuticals Ltd
2. Atenolol 100 mg Tablets Shelys Pharmaceuticals Ltd
3. Atorvastatin 10 mg Tablets Salama Pharmaceuticals Limited
4. Atorvastatin 20 mg Tablets Salama Pharmaceuticals Limited
5. Bisoprolol 5 mg Tablets Salama Pharmaceuticals Limited
6. Bisoprolol 10 mg Tablets LEK S. A
7. Gliclazide 30 mg Tablets Ipca Laboratories Ltd
8. Gliclazide 30 mg Tablets Mega Lifesciences (Australia) Pty. Ltd.
9. Gliclazide 60 mg Tablets Mega Lifesciences (Australia) Pty. Ltd.
10. Glimepiride 1 mg Tablets Sandoz GmbH
11. Glimepiride 2 mg Tablets Mankind Pharma Ltd
12. Glimepiride 2 mg Tablets Sandoz GmbH
13. Glimepiride 3 mg Tablets Aurobindo Pharma Ltd
14. Glimepiride 3 mg Tablets Mankind Pharma Ltd
15. Glimepiride 4 mg Tablets Aurobindo Pharma Ltd
16. Glimepiride 4 mg Tablets Mankind Pharma Ltd
17. Glimepiride 4 mg Tablets Sandoz GmbH
18. Human Insulin 3 ml Novo Nordisk
19. Human Insulin Novo Nordisk
20. Human Insulin Novo Nordisk
21. Insulin Detemir Novo Nordisk
22. Insulin Glargine Mylan Pharmaceuticals Private Ltd
23. Metformin Hydrochloride 500 mg Tablets MSN Laboratories Private Ltd
23. Metformin Hydrochloride 500 mg Tablets XR Hovid Bhd
24. Metformin Hydrochloride 500 mg Tablets XR S K Age Exports
25. Metformin Hydrochloride 500 mg Tablets Bafna Pharmaceuticals Ltd
26. Metformin Hydrochloride 500 mg Tablets Merck Serono Ltd
27. Metformin Hydrochloride 500 mg Tablets Shelys Pharmaceuticals Ltd
28. Metformin Hydrochloride 750 mg Tablest Mega Lifesciences Public Company Ltd
29. Metformin Hydrochloride 750 mg Tablets XR Cadila Healthcare Ltd
30. Metformin Hydrochloride 750 mg Tablets Merck Serono Ltd
31. Metformin Hydrochloride 850 mg Tablets Abacus Pharma (A) Ltd
32. Metformin Hydrochloride 850 mg Tablets Indoco Remedies Ltd
33. Metformin Hydrochloride 850 mg Tablets S Kant Healthcare Limited
34. Metformin Hydrochloride 850 mg Tablets Shelys Pharmaceuticals Ltd
35. Metformin Hydrochloride 1000 mg Tablets Mega Lifesciences Public Company Ltd
36. Metformin Hydrochloride 1000 mg Tablets Merck Serono Ltd
37. Metformini Hydrochloride 500 mg Tablets S K Age Exports
38. Sitagliptin 50 mg Tablets Getz Pharma (Pvt.) Ltd
39. Sitagliptin 50-100mg Tablets Bafna Pharmaceuticals Ltd
40. Sitagliptin 100 mg Tablets Getz Pharma (Pvt.) Ltd