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HA200

Product Details
WHO Product ID
HA200
Status
Prequalified
INN, dosage form and strength
Nevirapine Suspension, Oral 50mg/5mL
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Suspension, Oral
Applicant organization
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Bottle, Glass amber
Configuration
10ml, 25ml
Shelf life (months)
24
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, PET Amber
Configuration
100ml, 240ml
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cipla Ltd
Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Nevirapine
FPP Manufacturing Site(s)
Cipla Ltd
Unit I, Plot No 9, 10 & 15 Indore Special Economic Zone, Phase II, Dhar District
Pithampur,
Madhya Pradesh
454 775
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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