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TB229

Product Details
WHO Product ID
TB229
Status
Prequalified
INN, dosage form and strength
Para-aminosalicylate (sodium) Powder for Oral solution 4g
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Powder for Oral solution
Reference authority
State Agency of Medicines
Applicant organization
OlainFarm JSC
5 Rupnicu Street
Olaine,
2114
Latvia
Packaging details and storage conditions
Packaging Type
Sachet, Paper/PE/Al/PE; Sachet, Paper/PE/Al/Ethylene and acrylic acid co polymer
Configuration
25x1, 300x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C. Store in the original package in order to protect from
API Manufacturing Site(s)
By Organization
By Active Ingredient
Biochemical & Synthetic Products Pvt Ltd
Synthetic Section - Unit 1, Plot No 11/6/2029, Phase 2, Sri Venkateshwara Cooperative, Industrial Estate, Balanagar, Medak District
Hyderabad,
Telangana
500 037
India
Para-aminosalicylate (sodium)
FPP Manufacturing Site(s)
OlainFarm JSC
5 Rupnicu Street
Olaine,
2114
Latvia
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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