Fingolimod Grindeks

Medicinal product

(Invented) name

Fingolimod Grindeks

Active substance (s)

Fingolimodas

Strength

0,5 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

AS Grindeks, Latvija

Date of authorisation

2021-02-10

Date of renewal

Documents

4674_Fingolimod_Grindeks_kiet-kaps.doc

4674_pakuotes lapelis_2021-02-10.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2383/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Fingolimodas	0,5 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
105819	91919	1091919	lizdinė plokštelė	N28		Receptinis	LT/1/21/4674/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-28	Išregistruotas
2021-02-10	Registruotas