Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Zeposia 0.23 mg hard capsules.
Zeposia 0.46 mg hard capsules.
Zeposia 0.92 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Zeposia 0.23 mg hard capsules: Light grey opaque hard capsule, 14.3 mm, imprinted in black ink with “OZA” on the cap and “0.23 mg” on the body. Zeposia 0.46 mg hard capsules: Light grey opaque body and orange opaque cap hard capsule, 14.3 mm, imprinted in black ink with “OZA” on the cap and “0.46 mg” on the body. Zeposia 0.92 mg hard capsules: Orange opaque hard capsule, 14.3 mm, imprinted in black ink with “OZA” on the cap and “0.92 mg” on the body. |
Zeposia 0.23 mg hard capsules: Each hard capsule contains ozanimod hydrochloride equivalent to 0.23 mg ozanimod.
Zeposia 0.46 mg hard capsules: Each hard capsule contains ozanimod hydrochloride equivalent to 0.46 mg ozanimod.
Zeposia 0.92 mg hard capsules: Each hard capsule contains ozanimod hydrochloride equivalent to 0.92 mg ozanimod.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ozanimod |
Ozanimod is a potent sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity to sphingosine 1-phosphate receptors 1 and 5. Ozanimod has minimal or no activity on S1P~2, S1P3, and S1P4. In vitro, ozanimod and its major active metabolites demonstrated similar activity and selectivity for S1P1 and S1P5. The mechanism by which ozanimod exerts therapeutic effects in MS and UC is unknown, but may involve the reduction of lymphocyte migration into the central nervous system (CNS) and intestine. |
| List of Excipients |
|---|
|
Capsule content: Microcrystalline cellulose Capsule shell: Zeposia 0.23 mg and 0.46 mg: Gelatin Zeposia 0.92 mg capsule: Gelatin Printing ink: Shellac (E904) |
Polyvinyl chloride (pVC)/polychlorotrifluoroethylene (PCTFE)/aluminium foil blisters.
Treatment initiation pack: Zeposia 0.23 mg and 0.46 mg
Pack size of 7 hard capsules (4 × 0.23 mg, 3 × 0.46 mg).
Maintenance pack: Zeposia 0.92 mg
Pack size of 28 or 98 hard capsules.
Not all pack sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Treatment initiation pack – Zeposia 0.23 mg/0.46 mg hard capsules:
EU/1/20/1442/001 (Pack size of 7 hard capsules)
Maintenance pack – Zeposia 0.92 mg hard capsules:
EU/1/20/1442/002 (Pack size of 28 hard capsules)
EU/1/20/1442/003 (Pack size of 98 hard capsules)
Date of first authorisation: 20 May 2020
| Drug | Countries | |
|---|---|---|
| ZEPOSIA | Austria, Australia, Canada, Estonia, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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