Date: 2011-12-19
Type of information: Granting of a Market Authorisation in the EU
Product name: Edarbi® (Ipreziv®)
Compound: azilsartan medoxomil
Therapeutic area: Cardiovascular diseases
Action mechanism: azilsartan medoxomil is an angiotensin II receptor blocker.
Company: Takeda Pharmaceutical (Japan)
Disease: essential hypertension in adults
Latest news: * On 22 September 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Edarbi, 20 mg, 40 mg, 80 mg, tablet intended for the treatment of essential hypertension in adults.
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: 2011-12-07
Favourable opinion UE: 2011-09-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
