Ontilyv

Medicinal product

(Invented) name

Ontilyv

Active substance (s)

Opikaponas

Strength

50 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	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
108185	94289	1094289	lizdinė plokštelė	N10		Receptinis	EU/1/21/1578/005	Netiekiama	-	-	No	-	-
108186	94290	1094290	lizdinė plokštelė	N30		Receptinis	EU/1/21/1578/006	Netiekiama	-	-	No	-	-
108187	94291	1094291	lizdinė plokštelė	N90		Receptinis	EU/1/21/1578/007	Netiekiama	-	-	No	-	-
108188	94292	1094292	buteliukas	N10		Receptinis	EU/1/21/1578/008	Netiekiama	-	-	No	-	-
108189	94293	1094293	buteliukas	N30		Receptinis	EU/1/21/1578/009	Netiekiama	-	-	No	-	-
108190	94294	1094294	buteliukas	N90		Receptinis	EU/1/21/1578/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-02-21	Registruotas