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NT011

WHO Product ID
NT011
Status
Prequalified
INN, dosage form and strength
Praziquantel Tablet, Film-coated 600mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Neglected tropical diseases
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
Blister, Alu/Alu
Configuration
6x1, 10x10
Shelf life (months)
24
Packaging Type
Bottle, HDPE
Configuration
6x1, 100x1, 500x1, 1000x1
Shelf life (months)
24
API Manufacturing Site(s)
By Organization
By Active Ingredient
Solara Active Pharma Sciences Ltd
120 A & B, 36, 120P & 121 Industrial Area, Baikampady
New Mangalore,
Karnataka
575 011
India
Praziquantel
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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