Medicines/finished pharmaceutical products

Reference Number: 
HA602 (a)

Date of prequalification: 
08 January 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Aciclovir
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Powder for solution for injection 250mg/vial
Storage condition: 
Do not store above 25°C
Shelf life (months): 
24
Packaging: 
Vial Glass: 5x1
Applicant: 
Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece
FPP Manufacturing Site: 

Demo SA, 21st Km National Road Athens-Lamia, Krioneri, Attiki, 14568, Greece

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Acyclovir (sodium)) Mylan Laboratories Ltd (Unit 7), Plot No.14, 99 & 100 IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District, Telangana, 502 307, India
(Acyclovir (sodium)) Mylan Laboratories Ltd, Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Parawada (M), Visakhapatnam District, Andhra Pradesh, 531 021, India