# Ruxolitinib

Ruxolitinib (Jakavi, Ruxolitinib Viatris) has 2 EU-approved indications in 1 tumour type.

## Approved indications

### Myeloproliferative neoplasms

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | Polycythaemia vera only; Resistant to or intolerant of hydroxyurea |
| None | Monotherapy | Any line | Myelofibrosis only; Disease-related splenomegaly or symptoms |

## Products

### Ruxolitinib Viatris

- Company: Viatris Limited
- Target: JAK1 and JAK2 inhibitor
- Class: Janus-associated kinase (JAK) inhibitors
- ATC: L01EJ01
- EU approval: 18 Sep 2026
- Label revised: 24 Sep 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/ruxolitinib-viatris-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/ruxolitinib-viatris-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/ruxolitinib-viatris

Mechanism (SmPC section 5.1): Ruxolitinib selectively inhibits the Janus Associated Kinases JAK1 and JAK2, blocking downstream JAK-STAT signalling and cell proliferation.

### Jakavi

- Company: Novartis Europharm Limited
- Target: JAK1 and JAK2 inhibitor
- Class: Janus-associated kinase (JAK) inhibitors
- ATC: L01EJ01
- EU approval: 23 Aug 2012
- Label revised: 10 Nov 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/jakavi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/jakavi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/jakavi

Mechanism (SmPC section 5.1): Ruxolitinib selectively inhibits JAK1 and JAK2, blocking downstream JAK-STAT signaling and the proliferation of cytokine-dependent malignant cells.

## Label wording

- **Ruxolitinib** (Jakavi, Ruxolitinib Viatris), Myeloproliferative neoplasms, any line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/jakavi-epar-product-information_en.pdf)
- **Ruxolitinib** (Jakavi, Ruxolitinib Viatris), Myeloproliferative neoplasms, 2nd line: “Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/jakavi-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/ruxolitinib