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HA108

Product Details
WHO Product ID
HA108
Status
Prequalified
INN, dosage form and strength
Zidovudine Capsules, hard 100mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
Reference authority
Medicines and Healthcare products Regulatory Agency (MHRA)
Applicant organization
ViiV Healthcare UK Limited
980 Great West Road, Brentford
Middlesex,
TW8 9GS
United Kingdom of Great Britain and Northern Ireland
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC
Configuration
10x10
Shelf life (months)
60
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Aurobindo Pharma Ltd
Unit VIII, Survey No. 10 & 13, Gaddapothoram Village, Jinnaram Mandal, Sangareddy District
I.D.A Kazipally,
Telangana
520319
India
Zidovudine
FPP Manufacturing Site(s)
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
Poznan,
60-332
Poland
SC Europharm S.A
2 Panselelor
St. Brasov,
500419
Romania
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 5 , Part 7

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