Spectrila
asparaginase
Table of contents
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.
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List item
Spectrila : EPAR - Summary for the public (PDF/75.71 KB)
First published: 28/01/2016
Last updated: 28/01/2016
EMA/793954/2015 -
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List item
Spectrila : EPAR - Risk-management-plan summary (PDF/187.07 KB)
First published: 28/01/2016
Last updated: 18/06/2020
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Medac Gesellschaft fuer klinische Spezialpraeparate mbH
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Revision |
5
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Date of issue of marketing authorisation valid throughout the European Union |
14/01/2016
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Contact address |
Product information
24/09/2020 Spectrila - EMEA/H/C/002661 - R/0018
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
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.