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RH082

Product Details
WHO Product ID
RH082
Status
Prequalified
INN, dosage form and strength
Ethinylestradiol/Levonorgestrel Tablet, Sugar coated + Placebo Tablet, Sugar coated 30mcg/150mcg + 0mcg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Sugar coated + Tablet, Sugar coated
Reference authority
Federal Institute for Drugs & Medical Devices (BfArM)
Applicant organization
Jenapharm GmbH & Co. KG
Otto-Schott-Str. 15, 07745
Jena,
Germany
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PE/PCTFE
Configuration
28 (21 Active + 7 Placebo) x1, 28x3, 28x6
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Bayer AG
Bergkamen Plant, Ernst Schering Strasse 14
Bergkamen,
59192
Germany
Ethinylestradiol, Levonorgestrel
FPP Manufacturing Site(s)
Bayer AG
Müllerstraße 178
Berlin,
13353
Germany
Bayer Weimar GmbH & Co KG
Doebereinerstrasse 20
Weimar,
99427
Germany
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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