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TB299

WHO Product ID
TB299
Status
Prequalified
INN, dosage form and strength
Linezolid Tablet, Film-coated 600mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Hetero Labs Ltd
7-2-A2, Industrial Estates, Sanath Nagar
Hyderabad,
Telangana
500 018
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
20x1, 100x1
Shelf life (months)
36
Packaging Type
Blister, Alu/Alu
Configuration
10x10
Shelf life (months)
60
API Manufacturing Site(s)
By Organization
By Active Ingredient
Symed Labs Limited (Unit-I)
Survey No 353, 354 & 467 Domadugu (Village), Gummadidala (Mandal), Sanga Reddy (Dist)
Telangana
502 313
India
Linezolid
FPP Manufacturing Site(s)
Hetero Labs Ltd
Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District
Telangana
509 301
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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