Siklos

RSS

hydroxycarbamide

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Siklos. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Siklos.

This EPAR was last updated on 12/06/2018

Authorisation details

Product details
Name
Siklos
Agency product number
EMEA/H/C/000689
Active substance
hydroxycarbamide
International non-proprietary name (INN) or common name
hydroxycarbamide
Therapeutic area (MeSH)
Anemia, Sickle Cell
Anatomical therapeutic chemical (ATC) code
L01XX05
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Addmedica
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
29/06/2007
Contact address
101 rue Saint Lazare
FR-75009 Paris
France

Product information

31/05/2018 Siklos - EMEA/H/C/000689 - IA/0038

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • 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

Antineoplastic agents

Therapeutic indication

Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic sickle-cell syndrome.

Assessment history

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