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RH083

Product Details
WHO Product ID
RH083
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
Steril-Gene Life Sciences (P) Ltd
No.15, Gopalakrishna Road, T. Nagar
Chennai,
600 017
India
Packaging details and storage conditions
Packaging Type
Ampoule, USP Type I glass
Configuration
1mLx5; 1mlx10; 1mlx100
Shelf life (months)
36
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
Piramal Pharma Limited
C-43 Off Thane Belapur Road MIDC, TTC Industrial Area Turbhe
Navi Mumbai, Thane,
Maharashtra
400703
India
Oxytocin
FPP Manufacturing Site(s)
Steril-Gene Life Sciences (P) Ltd.
45, Mangalam Main Road, Mangalam Village, Villianur Commune
Puducherry,
605 110
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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