ZEPOSIA Hard capsule Ref.[10643] Active ingredients: Ozanimod

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

Product name and form

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.

Qualitative and quantitative composition

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 sphingosine 1-phosphate (S1P) receptor modulator, which binds selectively to sphingosine 1-phosphate receptor subtypes 1 and 5. Ozanimod causes lymphocyte retention in lymphoid tissues.

List of Excipients

Capsule content:

Microcrystalline cellulose
Silica, colloidal anhydrous
Croscarmellose sodium
Magnesium stearate

Capsule shell:

Zeposia 0.23 mg and 0.46 mg:

Gelatin
Titanium dioxide (E171)
Yellow iron oxide (E172)
Black iron oxide (E172)
Red iron oxide (E172).

Zeposia 0.92 mg capsule:

Gelatin
Titanium dioxide (E171)
Yellow iron oxide (E172)
Red iron oxide (E172).

Printing ink:

Shellac (E904)
Iron oxide black (E172)
Propylene glycol (E1520)
Ammonia solution, concentrated (E527)
Potassium hydroxide (E525)

Pack sizes and marketing

Polyvinyl chloride (pVC)/polychlorotrifluoroethylene (PCTFE)/aluminium foil blisters.

Treatment initiation pack: Zeposia 0.23 mg and 0.46mg: 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.

Marketing authorization holder

Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

Marketing authorization dates and numbers

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

Drugs

Drug Countries
ZEPOSIA Austria, Australia, Canada, Estonia, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States

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