Ropitor

Medicinal product

(Invented) name

Ropitor

Active substance (s)

Ropinirolis

Strength

5 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)

N04BC04, Ropinirole

Marketing authorisation holder

Torrent Pharma GmbH, Vokietija

Date of authorisation

2008-12-30

Date of renewal

2014-01-24

Documents

1402_17-20 Ropitor_atn-01-24.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/0846/005/R/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Ropinirolis	5 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
21499	24378	1024378	buteliukas	N2		Receptinis	LT/1/08/1402/017	Netiekiama	-	-	No	-	-
33231	35601	1035601	buteliukas	N12		Receptinis	LT/1/08/1402/018	Netiekiama	-	-	No	-	-
33232	35602	1035602	buteliukas	N28		Receptinis	LT/1/08/1402/019	Netiekiama	-	-	No	-	-
33233	5031	1005031	buteliukas	N84		Receptinis	LT/1/08/1402/020	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-04-19	Išregistruotas
2014-01-24	Perregistruotas
2008-12-30	Registruotas