Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Omjjara 100 mg film-coated tablets.
Omjjara 150 mg film-coated tablets.
Omjjara 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Omjjara 100 mg film-coated tablets: Brown, round tablets, of approximately 8.7 mm diameter, with an underlined “M” debossed on one side and “100” on the other side. Omjjara 150 mg film-coated tablets: Brown, triangle shaped tablets, approximately 10.5 × 10.9 mm, with an underlined “M” debossed on one side and “150” on the other side. Omjjara 200 mg film-coated tablets: Brown, capsule shaped tablets, approximately 7.3 × 15.4 mm, with an underlined “M” debossed on one side and “200” on the other side. |
Each film-coated tablet contains momelotinib dihydrochloride monohydrate equivalent to 100 mg momelotinib.
Excipient with known effect: 50.8 mg lactose monohydrate per tablet.
Each film-coated tablet contains momelotinib dihydrochloride monohydrate equivalent to 150 mg momelotinib.
Excipient with known effect: 76.1 mg lactose monohydrate per tablet.
Each film-coated tablet contains momelotinib dihydrochloride monohydrate equivalent to 200 mg momelotinib.
Excipient with known effect: 101.5 mg lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Momelotinib |
Momelotinib and its major human circulating metabolite (M21), are inhibitors of wild type Janus Kinase 1 and 2 (JAK1/JAK2) and mutant JAK2V617F, which contribute to signalling of a number of cytokines and growth factors that are important for haematopoiesis and immune function. Momelotinib inhibits cytokine-induced STAT3 phosphorylation in whole blood from patients with myelofibrosis and inhibits hepcidin. Additionally, momelotinib and M21 are direct inhibitors of ACVR1, which further down regulates liver hepcidin expression resulting in increased iron availability and red blood cell production. |
| List of Excipients |
|---|
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Tablet core: Microcrystalline cellulose Tablet coating: Polyvinyl alcohol |
Each carton contains one white, high-density polyethylene (HDPE) bottle with a child-resistant polypropylene cap and induction-sealed, aluminium faced liner. Each bottle contains 30 film-coated tablets, a silica gel desiccant, and polyester coil.
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Omjjara 100 mg tablets: EU/1/23/1782/001
Omjjara 150 mg tablets: EU/1/23/1782/002
Omjjara 200 mg tablets: EU/1/23/1782/003
| Drug | Countries | |
|---|---|---|
| OMJJARA | Austria, Estonia, France, Croatia, Ireland, Lithuania |
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