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RH096

Product Details
WHO Product ID
RH096
Status
Prequalified
INN, dosage form and strength
Ethinylestradiol/Levonorgestrel Tablet, Film-coated 30mcg/150mcg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
HLL Lifecare Limited
Unipill Block, Kanagala, Belgaum
Karnataka
591225
India
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVDC
Configuration
21x10
Shelf life (months)
24
Storage conditions
Do not store above 30°C, protect from light. Avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Qinhuangdao Zizhu Pharmaceutical Co Ltd
No. 10 Longhai Road, Economic & Technological Development Zone
Qinhuangdao City,
Hebei
066 004
China
Ethinylestradiol, Levonorgestrel
FPP Manufacturing Site(s)
HLL Lifecare Limited
Unipill Block, Kanagala, Belgaum
Karnataka
591225
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 6 , Part 7 , Part 8

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