Ontozry

Medicinal product

(Invented) name

Ontozry

Active substance (s)

Cenobamatas

Strength

150 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	150 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
106313	92414	1092414	lizdinė plokštelė	N14		Receptinis	EU/1/21/1530/008	Netiekiama	-	-	No	-	-
106314	92415	1092415	lizdinė plokštelė	N28		Receptinis	EU/1/21/1530/009	Netiekiama	-	-	No	-	-
106315	92416	1092416	lizdinė plokštelė	N84		Receptinis	EU/1/21/1530/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas