Sobi Submits Application for Orfadin to EMA

September 3, 2013

Sobi's application for Orfadin oral suspension has been validated by EMA.

Sobi announced that the company's application for Orfadin oral suspension has been validated by EMA. This new dosage form has been developed to facilitate the accuracy in administration of the desired Orfadin dose to pediatric patients and to increase expediency for the patients and their caregivers.
 
The oral suspension is included in a Paediatric Investigation Plan agreed with EMA in March 2012.

Source: Sobi