Rolpryna SR

Medicinal product

(Invented) name

Rolpryna SR

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2011-03-01

Date of renewal

2017-07-27

Documents

2346 Rolpryna SR PCS PL 2023 07 26.docx

2346 Pakuotės lapelis 2023 07 26.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SK/H/0117/003/DC

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
36892	50504	1050504	lizdinė plokštelė	N21		Receptinis	LT/1/10/2346/009	Netiekiama	-	-	No	-	-
45314	59113	1059113	lizdinė plokštelė	N28		Receptinis	LT/1/10/2346/010	Tiekiama	-	-	No	-	-	Download
45315	59114	1059114	lizdinė plokštelė	N42		Receptinis	LT/1/10/2346/011	Netiekiama	-	-	No	-	-
45316	59115	1059115	lizdinė plokštelė	N84		Receptinis	LT/1/10/2346/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-07-27	Perregistruotas
2011-03-01	Registruotas