Medicines/finished pharmaceutical products

Reference Number: 
RH025 (a)

Date of prequalification: 
29 September 2010
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Desogestrel/Ethinylestradiol + Placebo
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 0.150mg/0.030mg + 0mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Blister Alu/PVC: (21+7)x3
Applicant: 
NV Organon, Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands
FPP Manufacturing Site: 

NV Organon, Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Ethinylestradiol) Aspen Oss B.V., Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands
(Ethinylestradiol) Aspen Oss B.V., Site De Geer, Veersemeer 4, JN OSS, 5347 JN, Netherlands
(Desogestrel) Aspen Oss B.V., Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands
(Desogestrel) Aspen Oss B.V., Site De Geer, Veersemeer 4, JN OSS, 5347 JN, Netherlands

API WHO Public Inspection Reports: