Oprymea

Medicinal product

(Invented) name

Oprymea

Active substance (s)

Pramipeksolis+Pramipeksolis+Pramipeksolis

Strength

0,26 mg + 0,52 mg + 1,05 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)

N04BC05, Pramipexole

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2008-09-12

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Prolonged-release tablet (0,26 mg)	1 vnt.
Pramipeksolis	0,26 mg
Prolonged-release tablet (0,52 mg)	1 vnt.
Pramipeksolis	0,52 mg
Prolonged-release tablet (1,05 mg)	1 vnt.
Pramipeksolis	1,05 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
66330	80855	1080855	lizdinė plokštelė	N21 (7x0,26mg+7x0,52mg+7x1,05mg) (gydymo pradžios pakuotė)		Receptinis	EU/1/08/469/054	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-09-12	Registruotas