Medicines/finished pharmaceutical products

Reference Number: 
HA532 (a)

Date of prequalification: 
11 September 2012
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Etravirine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 100mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 120x1
Applicant: 
Janssen Research & Development LLC, Turnhoutseweg 30, Beerse, 2340, Belgium
FPP Manufacturing Site: 

Janssen Pharmaceutica NV, Janssen Pharmaceuticalan 3, Geel, 2440, Belgium
Janssen-Cilag SpA, Via C Janssen, Borgo San Michele, Latina, 4010, Italy

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Etravirine) Janssen Pharmaceutica NV, Janssen Pharmaceuticalan 3, Geel, 2440, Belgium
(Etravirine) Janssen Pharmaceutica NV, Little Island , County Cork, Ireland

API WHO Public Inspection Reports: