Spectrila

RSS

asparaginase

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

Overview

This is a summary of the European public assessment report (EPAR) for Spectrila. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Spectrila.

For practical information about using Spectrila, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 08/05/2019

Authorisation details

Product details
Name
Spectrila
Agency product number
EMEA/H/C/002661
Active substance
asparaginase
International non-proprietary name (INN) or common name
asparaginase
Therapeutic area (MeSH)
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anatomical therapeutic chemical (ATC) code
L01XX02
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Medac Gesellschaft fuer klinische Spezialpraeparate mbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
14/01/2016
Contact address
Theaterstrasse 6
22880 Wedel
Germany

Product information

26/04/2019 Spectrila - EMEA/H/C/002661 - PSUSA/00010445/201807

Contents

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

Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.

Assessment history

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