Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Gliolan   
Auth. number : EU/1/07/413
Active substance : 5-aminolevulinic acid hydrochloride
Orphan market exclusivity for "Intra-operative photodynamic diagnosis of residual glioma" (based on designation EU/3/02/121) started on 12/09/2007
   10 years of market exclusivity
   This orphan market exclusivity has ended on 12/09/2017
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XD - Sensitizers used in photodynamic/radiation therapy
Chemical substance: L01XD04 - aminolevulinic acid
(See WHO ATC Index)
Indication: Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV).
Marketing Authorisation Holder: medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
11/09/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/744 (2007)4239 of 07/09/2007
12/09/2007 Centralised - Authorisation EMEA/H/C/744 (2007)4237 of 07/09/2007
06/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/744/IA/1
16/08/2011 Centralised - Variation EMEA/H/C/744/IA/2
Updated with Decision(2012)1192 of 17/02/2012
22/02/2012 Centralised - Variation (2012)1192 of 17/02/2012
04/09/2012 Centralised - Renewal EMEA/H/C/744/R/3 (2012)6168 of 30/08/2012
17/01/2014 Centralised - Variation EMEA/H/C/744/IB/7
Updated with Decision(2015)283 of 19/01/2015
17/03/2014 Centralised - Variation EMEA/H/C/744/IAIN/8/G
Updated with Decision(2015)283 of 19/01/2015
21/01/2015 Centralised - Yearly update (2015)283 of 19/01/2015
12/09/2017 Centralised - (orphan status)