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RH099

Product Details
WHO Product ID
RH099
Status
Prequalified
INN, dosage form and strength
Misoprostol Tablet, vaginal 25μg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet, vaginal
Reference authority
Agencia Española de Medicamentos y Productos Sanitorios
Applicant organization
BIAL-Portela & Ca. SA
A Av. da Siderurgia Nacional
Coronado,
4745-457
Portugal
Packaging details and storage conditions
Packaging Type
Blister, Alu/Alu
Configuration
8x1
Shelf life (months)
36
Storage conditions
Do not store above 25°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Everlight Chemical Industrial Corp
Factory 12, Industrial Third Road, Kuanyin Industrial District, Kuanyin Hsiang
Taoyuan Hsien,
China, Province of Taiwan
Misoprostol - 1% dispersion in HPMC
FPP Manufacturing Site(s)
Everlight Chemical Industrial Corp
Factory 12, Industrial Third Road, Kuanyin Industrial District, Kuanyin Hsiang
Taoyuan Hsien,
China, Province of Taiwan
INDUSTRIA QUIMICA Y FARMACEUTICA VIR S A
Laguna 66 68 70 Poligono Industrial Urtinsa II, Alcorcon
Madrid,
28923
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 7

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