← Drug database

Quinsair (levofloxacin)

Region
🇪🇺 EU
Active substance
levofloxacin
Company
Chiesi Farmaceutici S.p.A
Status
Authorised
Therapeutic area
Cystic Fibrosis; Respiratory Tract Infections
CHMP opinion
Thu 18 Dec 2014
EU approval
Wed 25 Mar 2015
Application
EMEA/H/C/002789
ATC
J01MA12
Official record
www.ema.europa.eu

Indication

Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Regulatory milestones

No milestones recorded in the last year.

Follow Quinsair

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.