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NT002

Product Details
WHO Product ID
NT002
Status
Prequalified
INN, dosage form and strength
Diethylcarbamazine (citrate) Tablet 100mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Neglected tropical diseases
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Applicant organization
Eisai Co Ltd
4-6-10 Koishikawa, Bunkyo-Ku
Tokyo,
112-8088
Japan
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
1000x1
Shelf life (months)
60
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Saurav Chemicals Ltd
Derabassi-Barwala Road, Village Bhagwanpura, District Sahibzada Ajit Singh Nagar
Tehsil Derabassi,
Punjab
140 507
India
Diethylcarbamazine (citrate)
FPP Manufacturing Site(s)
Eisai Pharmatechnology and Manufacturing Pvt Ltd
Plot No 96, 97, 98, 124 & 126 Ramky Pharma City (SEZ), Parawada, Visakhapatnam District
Andhra Pradesh
531 019
India
WHO Public Assessment Reports


Part 1 - Abstract
Part 2a - All accepted presentations
Part 2b - Visual appearance of the product
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. 

Samples of the artworks of the SPC/PIL/labelling have not been submitted. Therefore, control of compliance with WHOPAR guidelines (contents and format) has not been possible.

Part 1 , Part 2a , Part 2b , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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