Gilenya

Medicinal product

(Invented) name

Gilenya

Active substance (s)

Fingolimodas

Strength

0,25 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AE01, Fingolimod

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2011-03-17

Date of renewal

Documents

Gilenya mokomoji medziaga pacientui_tevams_globejams.pdf

Gilenya gydytojo kontrolinis sarasas.pdf

Gilenya pacientes kortele.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Fingolimodas	0,25 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
100706	86816	1086816	dalomoji lizdinė plokštelė	N7x1		Receptinis	EU/1/11/677/007	Netiekiama	-	-	No	-	-
100707	86817	1086817	lizdinė plokštelė	N28		Receptinis	EU/1/11/677/008	Netiekiama	-	-	No	-	-
109937	96044	1096044	lizdinė plokštelė	N7		Receptinis	EU/1/11/677/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-03-17	Registruotas