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IN005

Product Details
WHO Product ID
IN005
Status
Prequalified
INN, dosage form and strength
Oseltamivir (phosphate) Capsules, hard 45mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Influenza
Type
Finished Pharmaceutical Product
Dosage form
Capsules, hard
Reference authority
European Medicines Agency
Applicant organization
Roche Registration GmbH
Emil-Barell-Strasse
Grenzach-Wyhlen,
79639
Germany
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PE/PVdC
Configuration
10x1
Shelf life (months)
48
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
F. Hoffmann - La Roche Ltd
Basel,
CH-4070
Switzerland
Oseltamivir (phosphate)
Patheon API Inc
6173 E Old Marion Highway
Florence,
29506
United States
Oseltamivir (phosphate)
FPP Manufacturing Site(s)
Delpharm Milano S.r.l
Via Carnevale, 1, Segrate
Milan,
20054
Italy
F Hoffmann - La Roche Ltd
Wurmisweg
Kaiseraugst,
CH-4303
Switzerland
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 7

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