Skip to main content

HA428

Product Details
WHO Product ID
HA428
Status
Prequalified
INN, dosage form and strength
Efavirenz Tablet, Film-coated 200mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Reference authority
European Medicines Agency
Applicant organization
Merck Sharp & Dohme BV
Waarderweg 39
Haarlem,
2031 BN
Netherlands
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
90x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Fabbrica Italiana Sintetici S.p.A. (F.I.S.)
Viale Milano 26, Alte di Montecchio Maggiore
Vicenza,
36075
Italy
Efavirenz
Lonza Ltd.
Walliser Werke, Visp
CH-3930
Switzerland
Efavirenz
FPP Manufacturing Site(s)
Zhejiang Huahai Pharmaceutical Co Ltd
Xunqiao
Linhai,
Zhejiang
317 024
China
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

.