Evrysdi

Medicinal product

(Invented) name

Evrysdi

Active substance (s)

Risdiplamas

Strength

5 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)

M09AX10, risdiplam

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2021-03-26

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

Tabletėje yra:	1 vnt.
Risdiplamas	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
117688	103792	1103792	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/21/1531/002	Tiekiama	2025-08-06	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas