Ontilyv

Medicinal product

(Invented) name

Ontilyv

Active substance (s)

Opikaponas

Strength

25 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)

N04BX04, Opicapone

Marketing authorisation holder

BIAL-Portela & C, SA, Portugalija

Date of authorisation

2022-02-21

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Opikaponas	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
108181	94285	1094285	lizdinė plokštelė	N10		Receptinis	EU/1/21/1578/001	Netiekiama	-	-	No	-	-
108182	94286	1094286	lizdinė plokštelė	N30		Receptinis	EU/1/21/1578/002	Netiekiama	-	-	No	-	-
108183	94287	1094287	buteliukas	N10		Receptinis	EU/1/21/1578/003	Netiekiama	-	-	No	-	-
108184	94288	1094288	buteliukas	N30		Receptinis	EU/1/21/1578/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-02-21	Registruotas