This brand name is authorized in Austria, Croatia, Estonia, Finland, France, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Spain, Turkey, UK.
The drug UCEDANE contains one active pharmaceutical ingredient (API):
1
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UNII
5L0HB4V1EW - CARGLUMIC ACID
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Carglumic acid is a carbamoyl phosphate synthetase 1 (CPS 1) allosteric modulator. CPS1 is found in the mitochondria and is the first enzyme of the urea cycle, which converts ammonia into urea. Carglumic acid acts as a replacement for N-acetylglutamate (NAG) in N-acetylglutamate synthase (NAGS) deficiency patients by activating CPS1 but it does not help to regulate the urea cycle. Carglumic acid indicated as adjunctive therapy for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme NAGS. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| UCEDANE Dispersible tablet | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| A16AA05 | Carglumic acid | A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AA Amino acids and derivatives |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| EE | Ravimiamet | 1748729, 1777844 |
| ES | Centro de información online de medicamentos de la AEMPS | 1171202001 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 044691, 194133 |
| FR | Base de données publique des médicaments | 69083564 |
| GB | Medicines & Healthcare Products Regulatory Agency | 347541, 373360 |
| IT | Agenzia del Farmaco | 045485012 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1083208, 1088299 |
| NL | Z-Index G-Standaard, PRK | 81205 |
| NZ | Medicines and Medical Devices Safety Authority | 21260 |
| PL | Rejestru Produktów Leczniczych | 100392149 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8682214521414 |
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