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TB346

Product Details
WHO Product ID
TB346
Status
Prequalified
INN, dosage form and strength
Terizidone Capsules, hard 250mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
Reference authority
Federal Institute for Drugs & Medical Devices (BfArM)
Applicant organization
Esteve Pharmaceuticals GmbH
Hohenzollerndamm 150-151
Berlin
14199
Germany
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC
Configuration
10x5
Shelf life (months)
36
Storage conditions
Do not store above 25°C. Avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
ST Pharm Co Ltd
Sihwa Site, 231, Hyeomnyeok-ro, Siheung-si
15086
Republic of Korea
Terizidone
ST Pharm Co. Ltd
Banwol Site 2, 171, Haean-ro, Danwon-gu
Ansan-si,
15610
Korea, Rep.
Terizidone
FPP Manufacturing Site(s)
L-A-W Services GmbH – Leipziger Arzneimittelwerk
Elisabeth-Schumacher-Straße 54/56
Leipzig,
4328
Germany
Prestige Promotion Verkaufsförderung & Werbeservice GmbH
Lindigstraße 6
Kleinostheim,
63801
Germany
SW Pharma GmbH
Robert-Koch-Straße 1
Schiffweiler,
66578
Germany

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