SAI - Detailed view

AMVUTTRA Inj Lös Fertspr 0.5 ml

Drug

Name

AMVUTTRA®, Injektionslösung in einer Fertigspritze

Field of application

Amvuttra wird zur Behandlung der hereditären Transthyretin-Amyloidose bei erwachsenen Patienten mit Polyneuropathie der Stadien 1 oder 2 (hATTR-PN) angewendet Amvuttra wird zur Behandlung der Wildtyp- oder hereditären Transthyretin-Amyloidose bei erwachsenen Patienten mit Kardiomyopathie (ATTR-CM) angewendet.

ATC

N07XX18 - VUTRISIRAN

01.99.0. – various

Use

HAM – Human medicine

pharmaceutical form

INJFS – Suspension for injection in pre-filled syringe

Remedy code

TGT – transplant product: gene therapy product

Dispensing categories

B – Dispensed on prescription by a physician or veterinarian (B)

Authorisation status

Z – approved

Authorisation number

69074

Initial registration date

6/23/2023

Expiry date

6/22/2028

Dosage strength

Name

AMVUTTRA®, Injektionslösung in einer Fertigspritze

Field of application

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680690740016

Trade status*

In trade from / since 6/23/2023

Status

A/R – Authorised / referenced

Package size

1 pre-filled syringe(s)

Application type

SUBC – Subcutaneous use

Package code

001

Authorisation status

Z – approved

Declaration

Component Suspension

Active substance

25 mg vutrisiranum natricum

Excipient

natrii dihydrogenophosphas dihydricus
dinatrii phosphas dihydricus
natrii chloridum
aqua ad iniectabile
acidum phosphoricum
natrii hydroxidum
< 23 mg/ml natrium