Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: SpringWorks Therapeutics Ireland Limited, Hamilton House, 28 Fitzwilliam Place, Dublin 2, D02 P283, Ireland
Ezmekly 1 mg hard capsules.
Ezmekly 2 mg hard capsules.
| Pharmaceutical Form |
|---|
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Hard capsule (capsule). Ezmekly 1 mg hard capsules: Size 3 (approximately 16 mm × 6 mm) capsule comprised of a light green opaque body and cap with 'MIR 1 mg' printed in white ink on the cap. Ezmekly 2 mg hard capsules: Size 1 (approximately 19 mm × 7 mm) capsule comprised of a white opaque body and a blue‑green opaque cap with 'MIR 2 mg' printed in white ink on the cap. |
Ezmekly 1 mg hard capsules: Each hard capsule contains 1 mg of mirdametinib.
Ezmekly 2 mg hard capsules: Each hard capsule contains 2 mg of mirdametinib.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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Mirdametinib is a selective, non‑competitive inhibitor of mitogen‑activated protein kinase kinases 1 and 2 (MEK1/2). Mirdametinib blocks MEK activity and the rat sarcoma (RAS)‑rapidly accelerated fibrosarcoma (RAF)‑MEK pathway. Therefore, MEK inhibition blocks proliferation and survival of tumour cells in which the RAF‑MEK‑extracellular related kinase (ERK) pathway is activated. |
| List of Excipients |
|---|
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Capsule content: Microcrystalline cellulose (E460) Capsule shell: Gelatin (E441) Printing ink: Potassium hydroxide (E525) |
High‑density polyethylene (HDPE) bottle, secured with child‑resistant closure and aluminium foil induction seal.
1 mg hard capsules are provided in a carton containing one bottle of 42 capsules.
2 mg hard capsules are provided in a carton containing one bottle of 42 or 84 capsules.
Not all pack sizes may be marketed.
SpringWorks Therapeutics Ireland Limited, Hamilton House, 28 Fitzwilliam Place, Dublin 2, D02 P283, Ireland
EU/1/25/1950/003
EU/1/25/1950/004
EU/1/25/1950/005
Date of first authorisation: 17 July 2025
| Drug | Countries | |
|---|---|---|
| EZMEKLY | Austria, Estonia, Italy, Lithuania, Romania |
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