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RH100

WHO Product ID
RH100
Status
Prequalified
INN, dosage form and strength
Levonorgestrel Intra-uterine system 52mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Intra-uterine system
Reference authority
Finnish Medicines Agency
Administration Device
inserter (T-body, a plunger, flange, body and slider)
Applicant organization
Bayer AG
Müllerstraße 178
Berlin,
13353
Germany
Packaging details and storage conditions
Packaging Type
Blister, PETG/PE films 1x1 plus inserter (T-body, a plunger, flange, body and slider)
Configuration
1x1 plus inserter (T-body, a plunger, flange, body and slider)
Shelf life (months)
36
API Manufacturing Site(s)
By Organization
By Active Ingredient
Bayer AG
Bergkamen Plant, Ernst Schering Strasse 14
Bergkamen,
59192
Germany
Levonorgestrel
FPP Manufacturing Site(s)
Bayer Oy
Pansiontie 47
Turku,
20210
Finland
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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