Gliolan (5-aminolevulinic acid hydrochloride)
- Region
- 🇪🇺 EU
- Active substance
- 5-aminolevulinic acid hydrochloride
- Company
- Photonamic GmbH & Co. KG
- Status
- Authorised
- Therapeutic area
- Glioma
- CHMP opinion
- Thu 21 Jun 2007
- EU approval
- Fri 07 Sep 2007
- Application
- EMEA/H/C/000744
- ATC
- L01XD04
- Official record
- www.ema.europa.eu
Indication
Gliolan is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (World Health Organization grade III and IV).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ameluz Authorised · Biofrontera Bioscience GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.