European Commission
Public Health
Accessibility tools
Service tools
Language selector
- Current languageen
Navigation path
- European Commission
- Public health
- Reference documents
- Register
- Orphan products
- Carglumic acid
Community Register of medicinal products
Community register of orphan medicinal products | GRANTED |
Product information |
Carglumic acid
| EU orphan designation number: | EU/3/08/576
|
| Active ingredient: | Carglumic acid |
| Indication: | Treatment of methylmalonic acidaemia |
| Sponsor: | Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France |
| EU Centralised marketing authorisation: | A centralised EU marketing authorisation has been obtained under the name Carbaglu on 24/01/2003 with the number EU/1/02/246 |
Public summary of scientific opinion
EPAR
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 13/11/2008 | Centralised Orphan - Designation | EMEA/OD/045/08 | (2008)6861 of 07/11/2008 |