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5-Aminolevulinic Acid Hydrochloride

Ameluz, Gliolan · ATC code L01XD04

Key facts
Active substance
5-Aminolevulinic Acid Hydrochloride
ATC code
L01XD04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Ameluz 78 mg/g gel · Gliolan 30 mg/ml powder for oral solution.
Marketing authorisation holder
Biofrontera Bioscience GmbH, Photonamic GmbH & Co. KG
Information as of
2026-10-27

Key facts

5-Aminolevulinic acid hydrochloride is a precursor of the photosensitive protoporphyrin IX. As a gel (Ameluz) it is used in photodynamic therapy of skin lesions; as an oral solution (Gliolan) it is used to visualise malignant tissue during glioma surgery.

What it is used for

  • Ameluz: actinic keratosis of mild to moderate severity (Olsen grade 1 to 2) and field cancerization in adults
  • Ameluz: superficial and/or nodular basal cell carcinoma in adults when surgery is unsuitable
  • Gliolan: visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV) in adults

Dosing

  • Ameluz, actinic keratosis: one session of photodynamic therapy (face/scalp with daylight or lamp; trunk, neck, extremities with red light); lesions are evaluated after three months and retreated if not resolved
  • Ameluz, basal cell carcinoma: two red-light sessions about one week apart; evaluation after three months
  • Ameluz is for cutaneous use under the guidance of professionals experienced in photodynamic therapy
  • Gliolan: 20 mg 5-ALA HCl per kilogram body weight, taken orally three hours (range 2-4 hours) before anaesthesia
  • Gliolan only by experienced neurosurgeons trained in fluorescence-guided surgery; use with caution in renal or hepatic impairment

Contraindications

  • Hypersensitivity to the active substance or porphyrins (Ameluz also: soya or peanuts)
  • Porphyria
  • Ameluz: known photodermatoses (e.g. polymorphic light reaction, xeroderma pigmentosum, lupus erythematosus)
  • Gliolan: pregnancy

Important warnings

  • Ameluz: photodynamic therapy may very rarely precipitate transient global amnesia; PDT must then be stopped immediately
  • Ameluz: concomitant immunosuppressants are not recommended; not to be used on bleeding lesions
  • Ameluz: avoid contact with eyes and mucous membranes
  • Gliolan: fluorescence gives no information on neurological function; tumours near eloquent areas carry a higher risk of critical neurological deficits

Side effects

  • Ameluz: local skin reactions in most patients, mainly application site irritation, erythema, pain and oedema
  • Ameluz: symptoms are usually mild or moderate and occur during or shortly after illumination
  • Gliolan: most serious effects include anaemia, thrombocytopenia, leukocytosis, neurological disorders and thromboembolism
  • Gliolan: frequently vomiting, nausea and increases in bilirubin, liver enzymes and amylase; uncommonly hypotension and photosensitivity

Interactions

  • Ameluz: no interaction studies have been performed
  • Gliolan: no other photosensitising agents for up to 2 weeks after administration

Pregnancy and breastfeeding

  • Ameluz: preferably avoided in pregnancy as a precaution; breast-feeding should be discontinued for 12 hours after treatment
  • Gliolan: contraindicated in pregnancy; breast-feeding should be interrupted for 24 hours

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • AmeluzBiofrontera Bioscience GmbH · EMEA/H/C/002204
  • GliolanPhotonamic GmbH & Co. KG · EMEA/H/C/000744

Source: European Medicines Agency (EMA), product information

Austria

  • AlacarePhotonamic Gmbh & Co. Kg · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • AlacarePhotonamic Gmbh & Co. Kg · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • GlioscanPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 15 more European countries
Belgium
Effala
Czechia
Alacare
Denmark
Alacare
Finland
Alacare
France
Effala
Iceland
Ameluz
Ireland
Alacare
Italy
Alacare
Liechtenstein
Ameluz
Netherlands
Alacare
Norway
Alacare, Ameluz
Poland
Alacare
Portugal
Alacare
Slovakia
Alacare
Sweden
Alacare

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Ameluz – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/ameluz-epar-product-information_en.pdf
  2. European Medicines Agency. Gliolan – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/gliolan-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.