Date: 2012-03-21
Type of information:
Product name: Astepro®
Compound: azelastine
Therapeutic area:
Action mechanism: Astepro® is an antihistamine formulated as a metered-spray solution for intranasal administration.
Company: Meda (Sweden)
Disease: allergic rhinitis
Latest news: * On March 20, 2012, Meda has announced the approval of Astepro® in Europe. The product has received registration approval in Europe via the decentralized procedure. Astepro is a new nasal spray for the treatment of allergic rhinitis. National registration processes, including price and reimbursement, will now follow in each country. Launch is expected next year. The product was launched on the US market in October 2009
.
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: 2012-03-20
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
