Skip to main content

TD001

Product Details
WHO Product ID
TD001
Status
Prequalified
INN, dosage form and strength
Nicotine resinate (polacrilex) 20% Medicated chewing gum 2mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Disorders caused by tobacco use
Type
Finished Pharmaceutical Product
Dosage form
Medicated chewing gum
Reference authority
Swedish Medical Products Agency (MPA)
Applicant organization
McNeil Sweden AB
Box 4007
169 04 Solna,
Sweden
Packaging details and storage conditions
Packaging Type
Blister; PVC/PVDC/Alu
Configuration
12x1, 12x2, 12x4, 12x8, 12x17, 15x1, 15x2, 15x6, 15x7, 15x14
Shelf life (months)
24
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cambrex Charles City, Inc.
1205 11th Street
Charles City,
Iowa
50616
United States of America
Nicotine resinate (polacrilex) 20%
Siegfried Ltd.
Untere Brühlstrasse 4
4800 Zofingen
Switzerland
Nicotine resinate (polacrilex) 20%
FPP Manufacturing Site(s)
McNeil AB
Norrbroplatsen 2,
SE-251 09 Helsingborg,
Sweden
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 7

.