Xadago

Medicinal product

(Invented) name

Xadago

Active substance (s)

Safinamidas

Strength

50 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BD03, Safinamide

Marketing authorisation holder

Zambon S.p.A., Italija

Date of authorisation

2015-02-24

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

Film-coated tablet	1 vnt.
Safinamidas	50 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
61489	75828	1075828	lizdinė plokštelė	N14		Receptinis	EU/1/14/984/001	Netiekiama	-	-	No	-	-
61490	75829	1075829	lizdinė plokštelė	N28		Receptinis	EU/1/14/984/002	Netiekiama	-	-	No	-	-
61491	75830	1075830	lizdinė plokštelė	N30		Receptinis	EU/1/14/984/003	Tiekiama	-	-	No	-	-
61492	75831	1075831	lizdinė plokštelė	N90		Receptinis	EU/1/14/984/004	Netiekiama	-	-	No	-	-
61493	75832	1075832	lizdinė plokštelė	N100		Receptinis	EU/1/14/984/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-02-24	Registruotas