Date: 2012-01-27
Type of information:
Product name: Rebif®
Compound: interferon beta-1a
Therapeutic area:
Action mechanism:
Company: Merck KGaA (Germany)
Disease: early signs of multiple sclerosis
Latest news: * On November 17, 2011, the Committee for Medicinal Products for Human Use
(CHMP), gave a positive opinion for Merck's variation application to extend the indication of Rebif®. The positive CHMP opinion is for the use of Rebif 44 micrograms three times weekly in patients who have experienced a single demyelinating event, an early sign of the disease, and who are at high risk of converting to multiple sclerosis.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2012-01-25
Favourable opinion UE: 2011-11-17
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
