Medicines/finished pharmaceutical products

Reference Number: 
HA427 (a)

Date of prequalification: 
14 May 2008
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Efavirenz
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Film-coated 50mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Bottle HDPE: 30x1
Applicant: 
Merck Sharp & Dohme BV, Waarderweg 39, Haarlem, 2031 BN, Netherlands
FPP Manufacturing Site: 

Zhejiang Huahai Pharmaceutical Co Ltd, Xunqiao, Linhai, Zhejiang Province, 317 024, China (People's Republic of)

API Manufacturing Site: 

(Efavirenz) Lonza Ltd., Walliser Werke, Visp, CH-3930, Switzerland
(Efavirenz) F.I.S. – Fabbrica Italiana Sintetici, Viale Milano, 26, 36075 Alte di Montecchio Maggiore, Vicenza, Italy

API WHO Public Inspection Reports: