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TB367

Product Details
WHO Product ID
TB367
Status
Prequalified
INN, dosage form and strength
Ethambutol hydrochloride Tablet, Dispersible 50mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Applicant organization
Micro Labs Limited
31 Race Course Road
Bangalore,
Karnataka
560 001
India
Packaging details and storage conditions
Packaging Type
Strip, Alu/Alu
Configuration
10x10, 28x24
Shelf life (months)
48
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Micro Labs Limited
API - Division (ML-15), Plot No.43-45, KIADB, Jigani-Bommasandra Link Road, Anekal Taluk
Bengaluru,
Karnataka
560 105
India
Ethambutol hydrochloride
FPP Manufacturing Site(s)
Micro Labs Limited
Unit 3, 92 Sipcot Industrial Complex
Hosur,
Tamil Nadu
635 126
India
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 6 , Part 7 , Part 8

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