Hirobriz Breezhaler (indacaterol)
- Region
- 🇪🇺 EU
- Active substance
- indacaterol
- Company
- Novartis Europharm Limited
- Status
- Withdrawn
- Therapeutic area
- Pulmonary Disease, Chronic Obstructive
- CHMP opinion
- Thu 24 Sep 2009
- EU approval
- Mon 30 Nov 2009
- Application
- EMEA/H/C/001211
- ATC
- R03AC18
- Official record
- www.ema.europa.eu
Indication
Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Oslif Breezhaler Withdrawn · Novartis Europharm Limited
- 🇪🇺 Atectura Breezhaler Authorised · Novartis Europharm Limited
- 🇪🇺 Enerzair Breezhaler Authorised · Novartis Europharm Limited
- 🇪🇺 Onbrez Breezhaler Authorised · Novartis Europharm Limited
- 🇪🇺 Zimbus Breezhaler Authorised · Novartis Europharm Limited
- 🇪🇺 Bemrist Breezhaler Authorised · Novartis Europharm Limited
- 🇪🇺 Xoterna Breezhaler Authorised · Novartis Europharm Limited
- 🇪🇺 Ultibro Breezhaler Authorised · Novartis Europharm Limited
- 🇪🇺 Ulunar Breezhaler Authorised · Novartis Europharm Limited
Follow Hirobriz Breezhaler
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.