Hemoprostol: Opinion on medicine for use outside EU
misoprostol
Table of contents
Opinion on medicine for use outside the European Union
Withdrawn opinion
Overview
The opinion for Hemoprostol for use outside the European Union has been withdrawn at the request of the opinion holder.
Opinion details
Product details | |
---|---|
Name of medicinal product |
Hemoprostol
|
Agency opinion number |
H-W-2652
|
Opinion status |
Withdrawn opinion
|
Active substance |
misoprostol
|
International non-proprietary name (INN) or common name |
misoprostol
|
Therapeutic area (MeSH) |
Postpartum Hemorrhage
|
Anatomical therapeutic chemical (ATC) code |
G02AD06
|
Publication details | |
---|---|
Opinion holder |
Linepharma International Limited |
Date of opinion |
23/01/2014
|
Product information
26/03/2015 Hemoprostol H-W-2652-IAIN-0003
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturer responsible for batch release
- Annex IIB - Recommendations to the opinion holder - conditions of use
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Pharmacotherapeutic group
Other gynecologicals
Therapeutic indication
Therapeutic indication
Hemoprostol is indicated in women of childbearing age for treatment of Post Partum Haemorrhage due to uterine atony in situations where intravenous oxytocin is not available.
Assessment history
-
List item
Hemoprostol: Withdrawal of the Article 58 scientific opinion - Public statement (PDF/66.54 KB)
First published: 26/04/2017
Last updated: 26/04/2017
EMA/195172/2017 -
List item
Hemoprostol : Procedural steps taken and scientific information after opinion (PDF/972.48 KB)
First published: 21/07/2015
Last updated: 26/04/2017 -
List item
Hemoprostol : Public assessment report (PDF/3.43 MB)
Adopted
First published: 10/04/2014
Last updated: 26/04/2017
EMA/CHMP/364824/2013 -
List item
Hemoprostol : All presentations (PDF/930.36 KB)
First published: 10/04/2014
Last updated: 26/04/2017 -
List item
CHMP summary of positive opinion for Hemoprostol (PDF/1000.9 KB)
Adopted
First published: 24/01/2014
Last updated: 26/04/2017
EMA/CHMP/750274/2013