Medicines/finished pharmaceutical products

Reference Number: 
TB345 (a)

Date of prequalification: 
14 March 2018
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Protionamide
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Film-coated 250mg
Storage condition: 
Alu/PVC blister: Do not store above 25°C; PP container: Do not store above 30°C
Shelf life (months): 
60
Packaging: 
Bottle, PP container with LDPE closure 100x1; Blister, Alu/PVC 10x5
Applicant: 
RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald, Germany
FPP Manufacturing Site: 

SW Pharma GmbH, Robert-Koch-Straße 1, 66578 Schiffweiler, Germany
L-A-W Services GmbH – Leipziger Arzneimittelwerk, Elisabeth-Schumacher-Straße 54/56, 04328 Leipzig, Germany

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Protionamide) Pen Tsao Chemical & Pharmaceutical Industry Co. Ltd, No 2 Tieli Road, Wusong, Shanghai, 200 940, China (People's Republic of)