Active ingredients: Carglumic acid
Carbaglu 200 mg dispersible tablets.
The tablets are white and elongated with three score marks and engraved on one side.
The tablet can be divided into equal halves.
Each tablet contains 200 mg of carglumic acid.
For a full list of excipients, see section 6.1.
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.
silica colloidal anhydrous
sodium stearyl fumarate
5-, 15- or 60- high density polyethylene tablet containers closed by a child resistant polypropylene cap with a desiccant unit.
Not all pack sizes may be marketed.
Recordati Rare Diseases, Immeuble “Le Wilson”, 70, avenue du Général de Gaulle, F-92800, Puteaux, France
EU/1/02/246/001 (15 dispersible tablets)
EU/1/02/246/002 (60 dispersible tablets)
EU/1/02/246/003 (5 dispersible tablets)
Date of first authorisation: 24 January 2003
Date of renewal: 20 May 2008