Amvuttra

Medicinal product

(Invented) name

Amvuttra

Active substance (s)

Vutrisiranas

Strength

25 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX18, vutrisiran

Marketing authorisation holder

Alnylam Netherlands B.V., Nyderlandai

Date of authorisation

2022-09-15

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

Solution for injection in pre-filled syringe	0.5 ml
Vutrisiranas	25 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
109447	95553	1095553	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/22/1681/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-15	Registruotas