Jakavi (ruxolitinib)
- Region
- 🇪🇺 EU
- Active substance
- ruxolitinib
- Company
- Novartis Europharm Limited
- Status
- Authorised
- Therapeutic area
- Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease
- CHMP opinion
- Thu 19 Apr 2012
- EU approval
- Thu 23 Aug 2012
- Application
- EMEA/H/C/002464
- ATC
- L01EJ01
- Official record
- www.ema.europa.eu
Indication
Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Acute GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).Chronic GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1). Myelofibrosis (MF)Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.Polycythaemia vera (PV)Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.Graft versus host disease (GvHD)Acute GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).Chronic GvHDJakavi is indicated for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ruxolitinib Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Ruxolitinib Krka Opinion · KRKA tovarna zdravil d.d. Novo mesto
- 🇺🇸 Jakafi Xr Approved · Incyte Corp
- 🇪🇺 Ruxolitinib Viatris Authorised · Viatris Limited
- 🇪🇺 Opzelura Authorised · Incyte Biosciences Distribution B.V.
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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.