Leganto

Medicinal product

(Invented) name

Leganto

Active substance (s)

Rotigotinas+Rotigotinas+Rotigotinas+Rotigotinas

Strength

2 mg/24 h + 4 mg/24 h + 6 mg/24 h + 8 mg/24 h

Pharmaceutical form

transderminis pleistras

Route (s) of administration

vartoti per odą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BC09, Rotigotine

Marketing authorisation holder

UCB Pharma S.A., Belgija

Date of authorisation

2011-06-16

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Transdermal patch (2 mg/24 h)	1 vnt.
Rotigotinas	2 mg/24 h
Transdermal patch (4 mg/24 h)	1 vnt.
Rotigotinas	4 mg/24 h
Transdermal patch (6 mg/24 h)	1 vnt.
Rotigotinas	6 mg/24 h
Transdermal patch (8 mg/24 h)	1 vnt.
Rotigotinas	8 mg/24 h

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
47485	61302	1061302	paketėlis	N28 (7 x 2 mg/24h, 7 x 4 mg/24h, 7 x 6 mg/24h, 7 x 8 mg/24h)		Receptinis	EU/1/11/695/055	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-13	Išregistruotas
2011-06-16	Registruotas