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HA602

Product Details
WHO Product ID
HA602
Status
Prequalified
INN, dosage form and strength
Aciclovir Powder for solution for injection 250mg/vial
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Powder for solution for injection
Reference authority
National Organization for Medicines (EOF)
Applicant organization
Demo SA
21st Km National Road Athens-Lamia
Krioneri,
14568
Greece
Packaging details and storage conditions
Packaging Type
Vial, Glass
Configuration
5x1
Shelf life (months)
24
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Mylan Laboratories Ltd (Unit 7)
Plot No.14, 99 & 100 IDA, Pashamylaram Phase-II, Patancheru, Sangareddy District
Telangana
502 307
India
Aciclovir
Mylan Laboratories Ltd
Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Tadi Village, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India
Aciclovir
FPP Manufacturing Site(s)
Demo SA
21st Km National Road Athens-Lamia
Krioneri,
14568
Greece
WHO Public Assessment Reports


Part 1 - Abstract
Part 2a - All accepted presentations
Part 2b - Visual appearance of the product
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. 

Samples of the artworks of the SPC/PIL/labelling have not been submitted. Therefore, control of compliance with WHOPAR guidelines (contents and format) has not been possible.

Part 1 , Part 2a , Part 2b , Part 3 , Part 4 , Part 5 , Part 7

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