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HA532

WHO Product ID
HA532
Status
Prequalified
INN, dosage form and strength
Etravirine Tablet 100mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Reference authority
European Medicines Agency
Applicant organization
Janssen Research & Development LLC
Turnhoutseweg 30
Beerse,
2340
Belgium
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
120x1
Shelf life (months)
36
API Manufacturing Site(s)
By Organization
By Active Ingredient
Janssen Pharmaceutica NV
Janssen Pharmaceuticalan 3
Geel,
2440
Belgium
Etravirine
Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)
Little Island Industrial Est.
Little Island,
Ireland
Etravirine
FPP Manufacturing Site(s)
Janssen Pharmaceutica NV
Janssen Pharmaceuticalan 3
Geel,
2440
Belgium
Janssen-Cilag SpA
Via C Janssen, Borgo San Michele
Latina,
4100
Italy
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
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. 

 

Part 1 , Part 2 , Part 7

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