Medicines/finished pharmaceutical products

Reference Number: 
HA638 (a)

Date of prequalification: 
12 December 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Morphine hydrochloride
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablets, Prolonged release 60mg
Storage condition: 
Do not store above 25°C
Shelf life (months): 
60
Packaging: 
Blister Alu/PVC: 10x1, 10x2, 10x3, 10x5, 10x6, 10x10
Applicant: 
GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria
FPP Manufacturing Site: 

GL Pharma GmbH, Schlossplatz 1, Lannach, A- 8502, Austria
G.L. Pharma GmbH, Arnethgasse 3, A-1160, Vienna, Austria

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Morphine hydrochloride) S.A.L.A.R.S. SpA, Via San Francesco, 5, Como, Lombardy, 22100, Italy
(Morphine hydrochloride) Johnson Matthey Macfarlan Smith, 10 Wheatfield Road, Edingburgh, Scotland, EH11 2QA, United Kingdom of Great Britain and Northern Ireland

API WHO Public Inspection Reports: