Ongentys

Medicinal product

(Invented) name

Ongentys

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

2016-06-24

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

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
66118	80640	1080640	lizdinė plokštelė	N10		Receptinis	EU/1/15/1066/001	Netiekiama	-	-	No	-	-
66119	80641	1080641	lizdinė plokštelė	N30		Receptinis	EU/1/15/1066/008	Netiekiama	-	-	No	-	-
66120	80642	1080642	buteliukas	N10		Receptinis	EU/1/15/1066/009	Netiekiama	-	-	No	-	-
66121	80643	1080643	buteliukas	N30		Receptinis	EU/1/15/1066/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-06-24	Registruotas