5-aminolevulinic acid hydrochloride

This medicine is authorised for use in the European Union.


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 28/04/2023

Authorisation details

Product details
Agency product number
Active substance
5-aminolevulinic acid hydrochloride
International non-proprietary name (INN) or common name
5-aminolevulinic acid hydrochloride
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Photonamic GmbH & Co. KG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

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

Product information

28/04/2023 Gliolan - EMEA/H/C/000744 - IB/0025

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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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