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TB345

Product Details
WHO Product ID
TB345
Status
Prequalified
INN, dosage form and strength
Protionamide Tablet, Film-coated 250mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
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)
60
Storage conditions
Do not store above 25°C
Packaging Type
Bottle, PP
Configuration
100x1
Shelf life (months)
60
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Pen Tsao Chemical & Pharmaceutical Industry Ltd
No 2 Teili Road, Wusong, Baoshan District
Yanghang Town,
Shanghai
200 940
China
Protionamide
FPP Manufacturing Site(s)
L-A-W Services GmbH – Leipziger Arzneimittelwerk
Elisabeth-Schumacher-Straße 54/56
Leipzig,
4328
Germany
SW Pharma GmbH
Robert-Koch-Straße 1
Schiffweiler,
66578
Germany
WHO Public Assessment Reports


Part 1 - Abstract
Part 2a - All accepted presentations
Part 2b - Visual appearance of the product
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)

* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities. 

Samples of the artworks of the SPC/PIL/labelling have not been submitted. Therefore, control of compliance with WHOPAR guidelines (contents and format) has not been possible.

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 7

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