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HA107

Product Details
WHO Product ID
HA107
Status
Prequalified
INN, dosage form and strength
Abacavir (sulfate) Solution, Oral 20mg/mL
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Solution, Oral
Reference authority
European Medicines Agency
Applicant organization
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
Amersfoort,
3811 LP
Netherlands
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
240x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Glaxo Operations UK Limited
Cobden Street, Angus
Montrose,
DD10 8EA
United Kingdom of Great Britain and Northern Ireland
Abacavir (sulfate)
Piramal Pharma Limited
Sy.Nos. 7-70, 70/1 and 70/2, Digwal (Vil), Kohir Mandal, Sangareddy District
Telangana
502 321
India
Abacavir (sulfate)
Thermo Fisher Scientific Cork Limited
Currabinny, Carrigaline, County Cork
Ireland
Abacavir (sulfate)
FPP Manufacturing Site(s)
Bora Pharmaceutical Services Inc.
7333 Mississauga North
Mississauga,
Ontario
L5N 6L4
Canada

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