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 13/10/2021

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
21
Date of issue of marketing authorisation valid throughout the European Union
29/06/2007
Contact address

37 rue de Caumartin
75009 Paris
France

Product information

16/12/2021 Siklos - EMEA/H/C/000689 - IB/0049

Product information documents contain:

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.

Assessment history

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