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RH054

Product Details
WHO Product ID
RH054
Status
Prequalified
INN, dosage form and strength
Estradiol valerate/Norethisterone enantate Solution for injection 5mg/50mg/mL
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Solution for injection
Applicant organization
Bayer AG
Müllerstraße 178
Berlin,
13353
Germany
Packaging details and storage conditions
Packaging Type
Ampoule, Type I Glass, brown
Configuration
1mlx1, 1mlx100
Shelf life (months)
60
Storage conditions
Do not store above 30°C, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
Bayer AG
Bergkamen Plant, Ernst Schering Strasse 14
Bergkamen,
59192
Germany
Estradiol valerate, Norethisterone enantate
FPP Manufacturing Site(s)
Bayer de México S.A. de C.V.
Reforma Avenue No. 46 Col Potrerillo, 94450 Ixtaczoquitlán
Veracruz de Ignacio de la Llave,
Mexico
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 6 , Part 7 , Part 8

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