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TB270

Product Details
WHO Product ID
TB270
Status
Prequalified
INN, dosage form and strength
Isoniazid/Rifampicin Capsules, hard 150mg/300mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
Reference authority
National Agency for Medicines and Medical Devices of Romania
Applicant organization
Antibiotice SA
1 Valea Lupului Street
Iasi,
Romania
Packaging details and storage conditions
Packaging Type
Blister, Al/PVC
Configuration
10x1, 10x100
Shelf life (months)
36
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Calyx Chemicals & Pharmaceuticals Ltd
Plot No-102/91/90, MIDC Industrial Area, Boisar
Tarapur,
Maharashtra
401 506
India
Isoniazid
Olon Active Pharmaceutical Ingredients India Private Limited
Plot No: L-1, L-21 to L-28 & L-44, Additional Phase MIDC, Raigad District
Mahad,
Maharashtra
402 301
India
Rifampicin
FPP Manufacturing Site(s)
Antibiotice SA
1 Valea Lupului Street
Iasi,
Romania
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 2a , Part 2b , Part 3 , Part 4 , Part 5 , Part 7

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