Bonaxon

Medicinal product

(Invented) name

Bonaxon

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

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2022-11-18

Date of renewal

Documents

5071_Bonaxon.docx

5071_pakuotes lapelis_2022-11-18.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/3098/001/E/001

Marketing authorisation procedure

Kartotinė 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
109852	95959	1095959	lizdinė plokštelė	N28		Receptinis	LT/1/22/5071/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-27	Išregistruotas
2022-11-18	Registruotas