Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands
Ucedane 200 mg dispersible tablets.
| Pharmaceutical Form |
|---|
|
Dispersible tablet. The tablets are rod-shaped, white and biconvex with three score lines on both sides and engraving “L/L/L/L” on one side. The tablet can be divided into four equal doses. |
Each tablet contains 200 mg of carglumic acid.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Carglumic acid |
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. |
| List of Excipients |
|---|
|
Microcrystalline cellulose |
Blister (ALU/ALU) packed in cartons.
Pack size of 12 or 60 dispersible tablets.
Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands
EU/1/17/1202/001
EU/1/17/1202/002
Date of first authorisation: 23 June 2017
| Drug | Countries | |
|---|---|---|
| UCEDANE | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Turkey, United Kingdom |
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