Gliolan

RSS

5-aminolevulinic acid hydrochloride

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 24/08/2018

Authorisation details

Product details
Name
Gliolan
Agency product number
EMEA/H/C/000744
Active substance
5-aminolevulinic acid hydrochloride
International non-proprietary name (INN) or common name
5-aminolevulinic acid hydrochloride
Therapeutic area (MeSH)
Glioma
Anatomical therapeutic chemical (ATC) code
L01XD04
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Medac GmbH
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
06/09/2007
Contact address
Fehlandtstrasse 3
D-20354 Hamburg
Germany

Product information

19/07/2018 Gliolan - EMEA/H/C/000744 - II/0016/G

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

Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (World Health Organization grade III and IV).

Assessment history

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