Fasturtec

RSS

rasburicase

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

Overview

This is a summary of the European public assessment report (EPAR) for Fasturtec. 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 Fasturtec.

This EPAR was last updated on 18/01/2018

Authorisation details

Product details
Name
Fasturtec
Agency product number
EMEA/H/C/000331
Active substance
rasburicase
International non-proprietary name (INN) or common name
rasburicase
Therapeutic area (MeSH)
Hyperuricemia
Anatomical therapeutic chemical (ATC) code
V03AF07
Publication details
Marketing-authorisation holder
Sanofi-aventis groupe 
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
23/02/2001
Contact address
Sanofi-aventis groupe
54, rue La Boétie
F-75008 Paris
France

Product information

23/11/2017 Fasturtec - EMEA/H/C/000331 - N/0054

Contents

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Pharmacotherapeutic group

ALL OTHER THERAPEUTIC PRODUCTS

Therapeutic indication

Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in adults, children and adolescents (aged 0 to 17 years) with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.

Assessment history

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