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TB336

Product Details
WHO Product ID
TB336
Status
Prequalified
INN, dosage form and strength
Rifapentine Tablet, Film-coated 150mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Reference authority
United States Food and Drug Administration
Applicant organization
Sanofi
82, avenue Raspail
Gentilly,
94250
France
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
8x3
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
API Manufacturing Site(s)
By Organization
By Active Ingredient
Euroapi Italy S.R.L.
Via Angelo Titi 22/26 Industrial zone
Brindisi,
Brindisi
72100
Italy
Rifapentine
FPP Manufacturing Site(s)
Sanofi S.p.A
Via Valcanello 4, 03012
Anagni,
Italy
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 7

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