Evrysdi

Medicinal product

(Invented) name

Evrysdi

Active substance (s)

Risdiplamas

Strength

0,75 mg/ml

Pharmaceutical form

milteliai geriamajam tirpalui

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

Evrysdi laiškas gydytojams 2025.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

Powder for oral solution	1 ml
Risdiplamas	0,75 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
106218	92319	1092319	buteliukas	buteliuko adapteris, 4 geriamieji švirkštai (2x6 ml ir 2x12 ml) N1		Receptinis	EU/1/21/1531/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-26	Registruotas