Fingolimod Olpha

Medicinal product

(Invented) name

Fingolimod Olpha

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

Olpha AS, Latvija

Date of authorisation

2025-06-10

Date of renewal

Documents

Fingolimod Olpha pacientes kortele.pdf

Fingolimod Olpha mokomoji medziaga pacientui_tevams_globejams.pdf

5799_Fingolimod Olpha.docx

5799_pakuotes lapelis_2025-06-10.docx

Fingolimod Olpha gydytojo kontrolinis sarasas.pdf

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3536/001/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
117715	103819	1103819	lizdinė plokštelė	N14		Receptinis	LT/1/25/5799/001	Netiekiama	-	-	No	-	-
117716	103820	1103820	lizdinė plokštelė	N28		Receptinis	LT/1/25/5799/002	Netiekiama	-	-	No	-	-
117717	103821	1103821	lizdinė plokštelė	N98		Receptinis	LT/1/25/5799/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-10	Registruotas