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RH070

Product Details
WHO Product ID
RH070
Status
Prequalified
INN, dosage form and strength
Ethinylestradiol/Levonorgestrel Tablet, Film-coated 0.03mg/0.15mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Laboratorios León Farma SA
C/La Vallina s/n, Polígono Industrial Navatejera, Villaquilambre
León,
24008
Spain
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PVDC
Configuration
21x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Aspen Oss B.V.
Veersemeer 4, 5347 JN
Oss,
Netherlands
Ethinylestradiol
Aspen Oss B.V.
Kloosterstraat 6, 5349 AB
Oss,
Netherlands
Ethinylestradiol
Industriale Chimica s.r.l.
Via E. H. Grieg 13, 21047
Saronno (Varese),
Italy
Levonorgestrel
FPP Manufacturing Site(s)
Laboratorios León Farma SA
C/La Vallina s/n, Polígono Industrial Navatejera, Villaquilambre
León,
24008
Spain
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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