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HA721

Product Details
WHO Product ID
HA721
Status
Prequalified
INN, dosage form and strength
Efavirenz/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 400mg/300mg/300mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Reference authority
United States Food and Drug Administration
Applicant organization
Mylan Laboratories Limited
Plot No.564/A/22, Road No. 92, Jubilee Hills
Hyderabad,
Telangana
500096
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
90x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, Blue HDPE
Configuration
30x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Bottle White, HDPE
Configuration
30x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, Blue HDPE
Configuration
90x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mylan Laboratories Limited
Unit 2, Survey 10/42, Gaddapotharam, Sangareddy District
Kazipally Industrial Area,
Telangana
502 319
India
Lamivudine
Mylan Laboratories Limited
Plot No. 86, Ramky Pharma City (India) Ltd, Parawada Mandal, Anakapalli District
Jawaharlal Nehru Pharma City,
Andhra Pradesh
531019
India
Efavirenz, Tenofovir disoproxil fumarate
Mylan Laboratories Limited
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Efavirenz
Mylan Laboratories Ltd
Unit 1, Survey 10, Gaddapotharam, Sangareddy
Kazipally Industrial Area,
Telangana
502 319
India
Lamivudine
FPP Manufacturing Site(s)
Mylan Laboratories Ltd
Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, District Dhar
Pithampur,
Madhya Pradesh
454 775
India
Mylan Laboratories Ltd
Plot No H-12 & H13 MIDC Waluj Industrial Area
Aurangabad,
Maharashtra
431 136
India
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 5 , Part 7

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