Ontozry

Medicinal product

(Invented) name

Ontozry

Active substance (s)

Cenobamatas

Strength

50 mg

Pharmaceutical form

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

Film-coated tablet	1 vnt.
Cenobamatas	50 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
106307	92408	1092408	lizdinė plokštelė	N14		Receptinis	EU/1/21/1530/002	Netiekiama	-	-	No	-	-
106308	92409	1092409	lizdinė plokštelė	N28		Receptinis	EU/1/21/1530/003	Netiekiama	-	-	No	-	-
106309	92410	1092410	lizdinė plokštelė	N84		Receptinis	EU/1/21/1530/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas