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RH042

Product Details
WHO Product ID
RH042
Status
Prequalified
INN, dosage form and strength
Ethinylestradiol/Levonorgestrel Tablet, Film-coated+Placebo Tablet 0.03mg/0.15mg+0mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet + Tablet, Film-coated
Reference authority
United States Food and Drug Administration
Applicant organization
Lupin Ltd.
Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East)
Mumbai,
Maharashtra
400 055
India
Packaging details and storage conditions
Packaging Type
Blister, PVC/Aclar
Configuration
(28x1)+(35x1) both blisters are sandwiched between one wallet carton
Shelf life (months)
24
Storage conditions
Do not store above 30°C, avoid excursions above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Lupin Limited
Unit 1, Plot No M-2 and M-2A, Special Economic Zone, Phase II SEZ, Misc Zone, Apparel Park, District Dhar
Pithampur,
Madhya Pradesh
454 774
India
Ethinylestradiol, Levonorgestrel
FPP Manufacturing Site(s)
Lupin Ltd
Unit 1, Plot No 2, Special Economic Zone, Phase II SEZ, District Dhar
Pithampur,
Madhya Pradesh
454 775
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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