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PPB

Marketing Authorisation Holder

Shilpa Medicare

India

8

Total Medicines

8

Active

6

Dosage Forms

2

Countries

Zambia (4) Tanzania (4)

Registration Status

Registered 8

Dosage Forms

Powder for solution for injection 2 Lyophilised powder for injection 2 Tablet, Film-coated 1 Solution for Injection 1 Solution for Infusion 1 Injection 1

Local Agents / Applicants

Shilpa Medicare Limited 8

Registered Medicines

Showing 8 of 8

Product	Form / Strength	Country	Reg. Number	Status
Bendamustine Hydrochloride for Injection 100 mg/ vial Bendamustine Hydrochloride for Injection 100 mg/ vial	Lyophilised powder for injection	Zambia	ZAMRA-HM-26-164	Registered/Compliant
Bendamustine Hydrochloride for Injection 25mg/vial Bendamustine Hydrochloride for Injection 25 mg/vial	Lyophilised powder for injection	Zambia	ZAMRA-HM-26-165	Registered/Compliant
Capecitabine Capecitabine 500 mg	Tablet, Film-coated 500 mg	Tanzania	TAN 23 HM 0238	Registered/Compliant
Docetaxel Docetaxel trihydrate equivalent to Docetaxel Anhydrous 80 mg	Injection 80 mg	Zambia	ZAMRA-HM-26-108	Registered/Compliant
Docetaxel 20 mg/ml solution for injection Docetaxel 20 mg/ml	Solution for Injection 20 mg/ml	Zambia	ZAMRA-HM-26-109	Registered/Compliant
GEMCITABINE 38 MG/ML sterile concentrate for injection Gemcitabine Hydrochloride 200 mg/5.26 ml	Powder for solution for injection 200 mg	Tanzania	TAN 22 HM 0476	Registered/Compliant
Gemcitabine 38 mg/mL concentrate for solution for infusion Gemcitabine Hydrochloride 1g/26.3 ml	Powder for solution for injection 1000	Tanzania	TAN 22 HM 0475	Registered/Compliant
Irinotecan Hydrochloride 20 mg/mL Concentrate for Solution for Infusion (5 mL) Hydrochloric acid q.s to pH 3.5 ml,Irinotecan hydrochloride trihydrate equivalent to Irinotecan 20 mg/0.05ml,Lactic acid [90%] 0.9 mg/6 mL,Sodium Hydroxide, q.s to pH 3.5 mg/6 mL,Sorbitol 400 [Low Endotoxin] 45.0 mg/6 mL,Water for Injection q.s to 1.0 ml	Solution for Infusion 100mg/5 mL	Tanzania	TAN 23 HM 0184	Registered/Compliant