Product Details
WHO Product ID
RH066
Status
Prequalified
INN, dosage form and strength
Desogestrel/Ethinylestradiol Tablet, Film-coated + Placebo Tablet, Film-coated 0.15mg/0.03mg + 0mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated + Tablet, Film-coated
Applicant organization
Laboratorios León Farma SA
C/La Vallina s/n, Polígono Industrial Navatejera, Villaquilambre
León,
24008
Spain
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC-PVdC
Configuration
28x1 (21 - active tablets, 7 - placebo tablets)
Shelf life (months)
24
Storage conditions
Do not store above 25°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Aspen Oss B.V.
Veersemeer 4, 5347 JN
Oss,
Netherlands
Ethinylestradiol
Aspen Oss B.V.
Kloosterstraat 6, 5349 AB
Oss,
Netherlands
Ethinylestradiol
Industriale Chimica s.r.l.
Via E. H. Grieg 13, 21047
Saronno (Varese),
Italy
Desogestrel
FPP Manufacturing Site(s)
Laboratorios León Farma SA
C/La Vallina s/n, Polígono Industrial Navatejera, Villaquilambre
León,
24008
Spain