Sifrol

Medicinal product

(Invented) name

Sifrol

Active substance (s)

Pramipeksolis

Strength

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

Boehringer Ingelheim International GmbH, Vokietija

Date of authorisation

1997-10-14

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Prolonged-release tablet	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
37710	51351	1051351	lizdinė plokštelė	N10		Receptinis	EU/1/97/050/019	Netiekiama	-	-	No	-	-
37716	51357	1051357	lizdinė plokštelė	N30		Receptinis	EU/1/97/050/020	Netiekiama	-	-	No	-	-
37717	51358	1051358	lizdinė plokštelė	N100		Receptinis	EU/1/97/050/021	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1997-10-14	Registruotas