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RH036

Product Details
WHO Product ID
RH036
Status
Prequalified
INN, dosage form and strength
Etonogestrel Implant 68mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Implant
Reference authority
Medicines Evaluation Board
Applicant organization
NV Organon
Kloosterstraat 6, Moleneind
AB Oss,
5349 AB
Netherlands
Packaging details and storage conditions
Packaging Type
Blister, PETG/HDPE
Configuration
5 x 1 (implant in a cannula of a disposable sterile)
Shelf life (months)
60
Storage conditions
Do not store above 30°C. Store in the original blister package
Packaging Type
Blister, PETG/HDPE
Configuration
1x1 (implant in a cannula of a disposable sterile)
Shelf life (months)
60
Storage conditions
Do not store above 30°C. Store in the original blister package
API Manufacturing Site(s)
By Organization
By Active Ingredient
Aspen Oss B.V.
Veersemeer 4, 5347 JN
Oss,
Netherlands
Etonogestrel
Aspen Oss B.V.
Kloosterstraat 6, 5349 AB
Oss,
Netherlands
Etonogestrel
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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