This brand name is authorized in Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom
The drug GLIOLAN contains one active pharmaceutical ingredient (API):
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1
Aminolevulinic acid
UNII V35KBM8JGR - AMINOLEVULINIC ACID HYDROCHLORIDE
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5-Aminolevulinic acid (5-ALA) is a natural biochemical precursor of heme that is metabolised in a series of enzymatic reactions to fluorescent porphyrins, particularly PPIX. 5-ALA synthesis is regulated by an intracellular pool of free heme via a negative feedback mechanism. Administration of excess exogenous 5-ALA avoids the negative feedback control, and accumulation of PPIX occurs in target tissue. In the presence of visible light, fluorescence of PPIX (photodynamic effect) in certain target tissues can be used for photodynamic diagnosis. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| GLIOLAN Powder for oral solution | European Medicines Agency (EU) | MPI, EU: SmPC | |
| Gliolan 30mg/ml powder for oral solution | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L01XD04 | Aminolevulinic acid | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01X Other antineoplastic agents → L01XD Sensitizers used in photodynamic/radiation therapy |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: EE | Ravimiamet | Identifier(s): 1347184, 1347195, 1347207 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 07413001 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 026045 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 63389433 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 198663 |
| Country: HK | Department of Health Drug Office | Identifier(s): 62756 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 046649012, 046649024, 046649036 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1028660, 1028661, 1028662 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 95826 |
| Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 17280 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100021358 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W69482001, W69482002, W69482003 |
| Country: SG | Health Sciences Authority | Identifier(s): 15244P |
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