Date: 2012-03-26
Type of information:
Product name: human anthrax monoclonal antibody
Compound: human anthrax monoclonal antibody
Therapeutic area:
Action mechanism:
Company: Emergent Sales and Marketing Germany GmbH (Germany)
Disease: inhalation anthrax disease
Latest news: *On January 11-12, 2011, the Committee for Orphan Medicinal Products (COMP) adopted a positive opinion recommending human anthrax monoclonal antibody for treatment of inhalation anthrax disease, for designation as orphan medicinal products to the European Commission.
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:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2011-04-15
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: