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RH050

Product Details
WHO Product ID
RH050
Status
Prequalified
INN, dosage form and strength
Oxytocin Solution for injection 10IU/mL
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Solution for injection
Applicant organization
PT Sanbe Farma
Jl. Taman Sari No 10
Bandung,
40116
Indonesia
Packaging details and storage conditions
Packaging Type
Ampoule, Type I glass
Configuration
1mLx10
Shelf life (months)
24
Storage conditions
Store in a refrigerator (2 °C to 8 °C), do not freeze, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
JSC Grindeks
53 Krustpils Street
Riga,
LV-1057
Latvia
Oxytocin
FPP Manufacturing Site(s)
PT Sanbe Farma
Sterile Preparation Plant, Unit 3, Jl. Industri Cimarene No. 8, Desa Cimareme, Kecamatan Ngamprah
Kabupaten Bandung Barat,
40553
Indonesia
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 2a , Part 2b , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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