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 10/08/2022

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
Photonamic GmbH & Co. KG
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
07/09/2007
Contact address

photonamic GmbH & Co. KG,
Eggerstedter Weg 12,
25421 Pinneberg,
GERMANY

Product information

05/08/2022 Gliolan - EMEA/H/C/000744 - IAIN/0022/G

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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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