Zeposia

Medicinal product

(Invented) name

Zeposia

Active substance (s)

Ozanimodas+Ozanimodas

Strength

0,23 mg + 0,46 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AE02, ozanimod

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2020-05-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Ozanimodas	0,23 mg
Hard capsule	1 vnt.
Ozanimodas	0,46 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
104219	90323	1090323	lizdinė plokštelė	N7 (0,23 mg N4 + 0,46 mg N3)	pakuotė gydymui pradėti	Receptinis	EU/1/20/1442/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-05-20	Registruotas