|
SMC2750
|
09/06/2025
|
ruxolitinib (Jakavi)
|
Full
|
Treatment of patients aged 12 years and older with acute graft versus host disease who have inadequate response to corticosteroids.
|
|
|
SMC2636
|
10/06/2024
|
momelotinib (Omjjara)
|
Abbreviated
|
For the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.
|
|
|
SMC2634
|
13/05/2024
|
ruxolitinib (Opzelura)
|
Full
|
For treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age
|
|
|
SMC2498
|
13/06/2022
|
ruxolitinib (Jakavi®)
|
Non submission
|
for the treatment of:
- patients aged 12 years and older with acute graft versus host disease who have inadequate response to corticosteroids
- patients aged 12 years and older with chronic graft versus host disease who have inadequate response to corticosteroids
|
|
|
SMC2462
|
11/04/2022
|
fedratinib (Inrebic)
|
Abbreviated
|
For treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are JAK inhibitor naïve or who have been treated with ruxolitinib.
|
|
|
SMC2213
|
09/12/2019
|
ruxolitinib (Jakavi)
|
Full
|
The treatment of adult patients with polycythaemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).
|
|
|
867/13
|
09/03/2015
|
ruxolitinib (Jakavi)
|
Full
|
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.
|
|
