Pramipexole Orion

Medicinal product

(Invented) name

Pramipexole Orion

Active substance (s)

Pramipeksolis

Strength

0,18 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BC05, Pramipexole

Marketing authorisation holder

Orion Corporation, Suomija

Date of authorisation

2009-09-08

Date of renewal

2014-07-01

Documents

1683 Pramipexole Orion PCS PL 2024 08 15.docx

1683 Pakuotės lapelis 2024 08 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/0811/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Pramipeksolis	0,18 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
29079	5490	1005490	lizdinė plokštelė	N30		Receptinis	LT/1/09/1683/003	Tiekiama	2025-04-24	-	No	-	-	Download
36647	38979	1038979	lizdinė plokštelė	N100		Receptinis	LT/1/09/1683/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-07-01	Perregistruotas
2009-09-08	Registruotas