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RH098

Product Details
WHO Product ID
RH098
Status
Prequalified
INN, dosage form and strength
Levonorgestrel Tablet 1.5mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet
Reference authority
Swedish Medical Products Agency (MPA)
Applicant organization
Naari BV
Kanaalstraat 12B
Oss,
Noord-Brabant
5347KM
Netherlands
Packaging details and storage conditions
Packaging Type
Blister, Alu-PVC
Configuration
1x1
Shelf life (months)
48
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Bayer AG (Suspended)
Charlottenburg Plant, Max-Dohrn-Strasse 8
Berlin,
10589
Germany
Levonorgestrel
Bayer AG
Bergkamen Plant, Ernst Schering Strasse 14
Bergkamen,
59192
Germany
Levonorgestrel
Industriale Chimica s.r.l.
Via E. H. Grieg 13, 21047
Saronno (Varese),
Italy
Levonorgestrel
FPP Manufacturing Site(s)
NAARI Pharma Private Limited
Plot No. 14-16 & 55-57, Sector-5, IIE, Pantnagar, Dist. - Udham Singh Nagar
Rudrapur,
Uttarakhand
263153
India
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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