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
Approved Product Information
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
6Atorkey Atorvastatin 20 mg tablets
7.Atorvastatin 10 mg TabletsAtorvastatin 10 mg Tablets
8.Atorvastatin 20 mg TabletsAtorvastatin 20 mg Tablets
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
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
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
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1ElosoneMometasone furoate 0.1%w/w
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1Fixet 200Cefixime 200 mg tablets
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
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
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1KlarClarithromycin 500 mg tablets
2KlarClarithromycin 250 mg tablets
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
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic 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
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1Ondansetron orodispersible tabletsOndansetron orodispersible 8 mg tablets
2Oratane 40Isotretinoin 40 mg soft gelatin capsules
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
591Pantin 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
SUMMARY OF PRODUCT CHARACTERISTICS
S/N Product Name Generic name
1RedmentinAmoxicillin 500 mg + Potassium clavulanate 125 mg
2Piperacillin sodium and Tazobactam sodiumPiperacillin sodium 2 g + Tazobactam sodium 0.25 g
3Rispitas 1Risperidone 1 mg tablets
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
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
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

Approved Product Information

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.