Siklos
hydroxycarbamide
Table of contents
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.
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List item
Siklos : EPAR - Summary for the public (PDF/79.25 KB)
First published: 10/08/2007
Last updated: 27/05/2014 -
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Siklos : EPAR - Risk-management-plan summary (PDF/296.17 KB)
First published: 01/10/2020
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Addmedica
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
29/06/2007
|
Contact address |
16 rue Montrosier |
Product information
27/01/2023 Siklos - EMEA/H/C/000689 - IAIN/0055
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.