Hemoprostol - opinion on medicine for use outside EU

misoprostol

Overview

The opinion for Hemoprostol for use outside the European Union has been withdrawn at the request of the opinion holder.

Hemoprostol : Medicine overview

Reference Number: EMA/51137/2014

Product information

Hemoprostol : Product information

Latest procedure affecting product information: H-W-2652-IAIN-0003

26/03/2015

Product information documents contain:

• 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

Hemoprostol : All presentations

Pharmacotherapeutic group

Other gynecologicals

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.

Opinion details

Product details

• Name of medicine:
  Hemoprostol
• EMA 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  Withdrawn opinion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

  Regents Place; 338 Euston Road; London NW1 3BT; United Kingdom

• Date of opinion:
  23/01/2014

Assessment history

Hemoprostol : Procedural steps taken and scientific information after opinion

Hemoprostol: Withdrawal of the Article 58 scientific opinion - Public statement

Reference Number: EMA/195172/2017

CHMP summary of positive opinion for Hemoprostol

AdoptedReference Number: EMA/CHMP/750274/2013

Hemoprostol : Public assessment report

AdoptedReference Number: EMA/CHMP/364824/2013