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CARBAGLU Dispersible tablet (2019)

Active ingredients: Carglumic acid

Product Name and Form

Carbaglu 200 mg dispersible tablets.

Pharmaceutical form

Dispersible tablet.

The tablets are white and elongated with three score marks and engraved on one side.

The tablet can be divided into equal halves.

Qualitative and Quantitative Composition

Each tablet contains 200 mg of carglumic acid.

For a full list of excipients, see section 6.1.

Chemical substance
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
sodium laurilsulfate
hypromellose
croscarmellose sodium
silica colloidal anhydrous
sodium stearyl fumarate

Pack sizes and Marketing

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.

Marketing authorization holder
Authorization dates

Recordati Rare Diseases, Immeuble “Le Wilson”, 70, avenue du Général de Gaulle, F-92800, Puteaux, France

Date of first authorisation: 24 January 2003

Date of renewal: 20 May 2008

Marketing authorization number:

EU/1/02/246/001 (15 dispersible tablets)
EU/1/02/246/002 (60 dispersible tablets)
EU/1/02/246/003 (5 dispersible tablets)