Sifrol

Medicinal product

(Invented) name

Sifrol

Active substance (s)

Pramipeksolis

Strength

1,57 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

2010-06-14

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	1,57 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
42251	56016	1056016	lizdinė plokštelė	N10		Receptinis	EU/1/97/050/028	Netiekiama	-	-	No	-	-
42252	56017	1056017	lizdinė plokštelė	N30		Receptinis	EU/1/97/050/029	Netiekiama	-	-	No	-	-
42253	56018	1056018	lizdinė plokštelė	N100		Receptinis	EU/1/97/050/030	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-06-14	Registruotas