Ropinirole Orion

Medicinal product

(Invented) name

Ropinirole Orion

Active substance (s)

Ropinirolis

Strength

8 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BC04, Ropinirole

Marketing authorisation holder

Orion Corporation, Suomija

Date of authorisation

2012-11-16

Date of renewal

2015-08-06

Documents

3132 Ropinirole Orion RPP 2024 01 19.docx

3132 Pakuotės lapelis 2024 01 19.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/0854/003

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ropinirolis	8 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
44148	57939	1057939	lizdinė plokštelė	N21		Receptinis	LT/1/12/3132/009	Netiekiama	-	-	No	-	-
54360	68352	1068352	lizdinė plokštelė	N28		Receptinis	LT/1/12/3132/010	Netiekiama	2024-11-28	2025-10-06	No	-	-
54361	68353	1068353	lizdinė plokštelė	N84		Receptinis	LT/1/12/3132/011	Netiekiama	-	-	No	-	-
54362	68354	1068354	buteliukas	N84		Receptinis	LT/1/12/3132/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-08-06	Perregistruotas
2012-11-16	Registruotas