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HA636

Product Details
WHO Product ID
HA636
Status
Prequalified
INN, dosage form and strength
Morphine hydrochloride Tablets, Prolonged release 10mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablets, Prolonged release
Reference authority
Austrian Agency for Health and Food Safety
Applicant organization
GL Pharma GmbH
Schlossplatz 1
Lannach,
A- 8502
Austria
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC
Configuration
10x1, 10x2, 10x3, 10x5, 10x6, 10x10
Shelf life (months)
36
Storage conditions
Do not store above 25°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Alcaliber S.A.U.
Av. Rio Ventalomar, 1, Poligono Industrial
Toledo
45007
Spain
Morphine hydrochloride
Johnson Matthey Macfarlan Smith
10 Wheatfield Road
Edingburgh,
EH11 2QA
United Kingdom of Great Britain and Northern Ireland
Morphine hydrochloride
S.A.L.A.R.S. SpA
Via San Francesco, 5
Como,
22100
Italy
Morphine hydrochloride
FPP Manufacturing Site(s)
G.L. Pharma GmbH
Arnethgasse 3, A-1160
Vienna,
Austria
GL Pharma GmbH
Schlossplatz 1
Lannach,
A- 8502
Austria
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 7

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