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HA748

Product Details
WHO Product ID
HA748
Status
Prequalified
INN, dosage form and strength
Sulfamethoxazole/Trimethoprim Tablet 800mg/160mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Reference authority
Swedish Medical Products Agency (MPA)
Applicant organization
Eumedica Pharmaceuticals AG
Arnold Boecklin Strasse 1
Basel,
4051
Switzerland
Packaging details and storage conditions
Packaging Type
Blister, Alu-PVC
Configuration
10x5
Shelf life (months)
60
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Ipca Laboratories Ltd
Sejavta, Ratlam
Madhya Pradesh
457 002
India
Trimethoprim
Micro-Macinazione SA
Via Cantonale 4
Monteggio,
6998
Switzerland
Sulfamethoxazole, Trimethoprim
Virchow Laboratories Ltd
Plot No 4 to 10, SV Cooperative Industrial Estate, IDA, Jeedimetla
Hyderabad,
500055
India
Sulfamethoxazole
FPP Manufacturing Site(s)
Cenexi SAS
52 Rue M. et J Gaucher
Fontenay sous Bois,
94120
France
Labor LS SE and Co KG
Mangelsfeld 4, 5, 6
Bocklet-Grossenbrach,
97708
Germany
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 7

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