Calmolan

Medicinal product

(Invented) name

Calmolan

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

G.L. Pharma GmbH, Austrija

Date of authorisation

2013-09-24

Date of renewal

Documents

3369_1_15 Calmolan tab PCS 160415.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1307/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	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
53094	67035	1067035	lizdinė plokštelė	N10		Receptinis	LT/1/13/3369/007	Netiekiama	-	-	No	-	-
57132	71246	1071246	lizdinė plokštelė	N30		Receptinis	LT/1/13/3369/008	Netiekiama	-	-	No	-	-
57133	71247	1071247	lizdinė plokštelė	N100		Receptinis	LT/1/13/3369/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-31	Išregistruotas
2013-09-24	Registruotas