Ontozry

Medicinal product

(Invented) name

Ontozry

Active substance (s)

Cenobamatas+Cenobamatas

Strength

12,5 mg + 25 mg

Pharmaceutical form

tabletės+plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N03AX25, cenobamate

Marketing authorisation holder

Angelini Pharma S.p.A., Italija

Date of authorisation

2021-03-26

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

Tablet	1 vnt.
Cenobamatas	12,5 mg
Film-coated tablet	1 vnt.
Cenobamatas	25 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
106306	92407	1092407	lizdinė plokštelė	N28 (14×12,5 mg + 14×25 mg)		Receptinis	EU/1/21/1530/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas