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RH025

Product Details
WHO Product ID
RH025
Status
Prequalified
INN, dosage form and strength
Desogestrel/Ethinylestradiol Tablet + Placebo Tablet, coated 0.150mg/0.030mg + 0mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet + Tablet, coated
Reference authority
Swedish Medical Products Agency (MPA)
Applicant organization
NV Organon
Kloosterstraat 6, Moleneind
AB Oss,
5349 AB
Netherlands
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC
Configuration
28x3; 28x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Aspen Oss B.V.
Veersemeer 4, 5347 JN
Oss,
Netherlands
Desogestrel, Ethinylestradiol
Aspen Oss B.V.
Kloosterstraat 6, 5349 AB
Oss,
Netherlands
Desogestrel, Ethinylestradiol
FPP Manufacturing Site(s)
NV Organon
Kloosterstraat 6, Moleneind
AB Oss,
5349 AB
Netherlands
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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