Posted by Michael Wonder on 07 Jul 2016
Shire receives extension of market authorization in Europe for Revestive (teduglutide) for the treatment of paediatric patients with short bowel syndrome
7 July 2016 - First therapy indicated in the EU for use in patients aged one year and above with short bowel syndrome, a rare gastro-intestinal condition.
Shire today announced that the European Commission has granted extension of market authorization for Revestive (teduglutide) 5 mg powder and solvent for solution for injection for the treatment of patients aged one year and above with short bowel syndrome (SBS). Patients should be stable following a period of intestinal adaptation after surgery.
The European Commission decision to grant extension of Market Authorization for Revestive in the treatment of paediatric patients with SBS follows a positive opinion adopted by the CHMP in May 2016.
