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HA569

Product Details
WHO Product ID
HA569
Status
Prequalified
INN, dosage form and strength
Nevirapine Tablet 100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVdC
Configuration
10x3, 10x6
Shelf life (months)
60
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Configuration
30x1, 60x1, 90x1
Shelf life (months)
60
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Hetero Labs Limited
Unit IX, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Nevirapine
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201 302
China
Nevirapine
Zhejiang Huahai Pharmaceutical Co Ltd
Costal Industrial Zone, Duqiao
Linhai,
Zhejiang
317 016
China
Nevirapine
FPP Manufacturing Site(s)
Micro Labs Limited
Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate
Verna,
Goa
403 722
India
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 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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