Orkambi (lumacaftor;ivacaftor)
- Region
- 🇪🇺 EU
- Active substance
- lumacaftor;ivacaftor
- Company
- Vertex Pharmaceuticals (Ireland) Limited
- Status
- Authorised
- Therapeutic area
- Cystic Fibrosis
- CHMP opinion
- Wed 23 Sep 2015
- EU approval
- Thu 19 Nov 2015
- Application
- EMEA/H/C/003954
- ATC
- R07AX30
- Official record
- www.ema.europa.eu
Indication
Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the CFTR gene. Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.
Regulatory milestones
No milestones recorded in the last year.
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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.