Hemoprostol H-W-2652

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Name of the medicinal productHemoprostol
Opinion holderLinepharma International Limited
Regents Place
338 Euston Road
London NW1 3BT
United Kingdom
Active substance

misoprostol

International non-proprietary name or common name

misoprostol

Pharmaco-therapeutic group

Other gynecologicals

ATC codeG02AD06
Therapeutic indicationHemoprostol 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.
Orphan medicinal product designation dateNot applicable

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Document(s) Language Status First published Last updated Effective Date
Hemoprostol: Withdrawal of the Article 58 scientific opinion - Public statement (English only)   2017-04-26    
Hemoprostol : Summary for the public (English only)   2014-04-10 2017-04-26  
Hemoprostol : Procedural steps taken and scientific information after the authorisation (English only)   2015-07-21 2017-04-26  
Hemoprostol : Risk-management-plan summary (English only)   2014-04-10 2017-04-26  
Hemoprostol : All presentations (English only)   2014-04-10 2017-04-26  
Hemoprostol : Public assessment report (English only) adopted 2014-04-10 2017-04-26  
CHMP summary of positive opinion for Hemoprostol (English only) adopted 2014-01-24 2017-04-26  

Product Information* 26/03/2015 Hemoprostol-H-W-2652-IAIN-0003

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Document(s) Language Status First published Last updated Effective Date
Hemoprostol : Product Information (English only)   2014-04-10 2017-04-26  

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*This document includes:

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.
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