Ameluz (5-aminolevulinic acid hydrochloride)
- Region
- 🇪🇺 EU
- Active substance
- 5-aminolevulinic acid hydrochloride
- Company
- Biofrontera Bioscience GmbH
- Status
- Authorised
- Therapeutic area
- Keratosis, Actinic; Carcinoma, Basal Cell
- CHMP opinion
- Thu 20 Oct 2011
- EU approval
- Tue 13 Dec 2011
- Application
- EMEA/H/C/002204
- ATC
- L01XD04
- Official record
- www.ema.europa.eu
Indication
Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2; see section 5.1) and of field cancerization in adults. Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.
Regulatory milestones
Ameluz: PDUFA target action date (superficial basal cell carcinoma (sBCC))
Biofrontera Inc. (BFRI); sNDA; status: set; "Recent Operational Highlights ● Announced FDA’s completion of its filing review and filing acceptance of the Company’s supplemental New Drug Application (sNDA) for Ameluz ® PDT for the treatment of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September 28, 2026."; filed 2026-05-14 · source
Same substance in other markets
- 🇪🇺 Gliolan Authorised · Photonamic GmbH & Co. KG
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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.