SAI - Detailed view

WAINZUA Inj Lös 45 mg/0.8ml Fertpen 0.8 ml

Drug

Name

WAINZUA, Injektionslösung

Field of application

Wainzua wird angewendet zur Behandlung erwachsener Patienten mit Polyneuropathie im Stadium 1 und 2 im Zusammenhang mit hereditärer Transthyretin-vermittelter Amyloidose (ATTRv).

ATC

N07XX21 - EPLONTERSEN

01.99.0. – various

Use

HAM – Human medicine

pharmaceutical form

INLFP – Solution for injection in pre-filled pen

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

69332

Initial registration date

2/14/2025

Expiry date

2/13/2030

Dosage strength

Name

WAINZUA, Injektionslösung

Field of application

Wainzua wird angewendet zur Behandlung erwachsener Patienten mit Polyneuropathie im Stadium 1 und 2 im Zusammenhang mit hereditärer Transthyretin-vermittelter Amyloidose (ATTRv).

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680693320017

Trade status*

In trade from / since 2/14/2025

Status

A/R – Authorised / referenced

Package size

1 Single-dose(s)

Application type

SUBC – Subcutaneous use

Package code

001

Authorisation status

Z – approved

Declaration

Component Solution

Active substance

56 mg/ml eplontersenum

Excipient

natrii dihydrogenophosphas dihydricus
dinatrii phosphas
natrii chloridum
acidum hydrochloridum
natrii hydroxidum
aqua ad iniectabile
< 1 mmol Natrium (23 mg) natrium