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TD005

Product Details
WHO Product ID
TD005
Status
Prequalified
INN, dosage form and strength
Nicotine Patch 25mg/16 hours
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Disorders caused by tobacco use
Type
Finished Pharmaceutical Product
Dosage form
Patch
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
Laminated pouch: Paper/PET/Alu/cyclo olefin copolymer coextrudate
Configuration
7,14,21,28 patches
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Siegfried Ltd.
Untere Brühlstrasse 4
4800 Zofingen
Switzerland
Nicotine
FPP Manufacturing Site(s)
LTS Lohmann Therapie-Systeme AG (LTS)
Lohmannstr. 2
D-56626 Andernach
Germany
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

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