Gliolan
5-aminolevulinic acid hydrochloride
Table of contents
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).
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Medac GmbH
|
Revision |
5
|
Date of issue of marketing authorisation valid throughout the European Union |
07/09/2007
|
Contact address |
Product information
27/10/2020 Gliolan - EMEA/H/C/000744 - II/0018/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).