SAI - Detailed view

OXLUMO 94.5 mg / 0.5 ml Inj Lös 94.5 mg 1 Stk

Drug

Name

Oxlumo, Injektionslösung

Field of application

Oxlumo wird zur Behandlung der primären Hyperoxalurie Typ 1 (PH1) in allen Altersgruppen angewendet

ATC

A16AX18 - LUMASIRAN

04.99.0. – various

Use

HAM – Human medicine

pharmaceutical form

LSINJ – Solution for injection

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

68239

Initial registration date

12/1/2021

Expiry date

11/30/2026

Dosage strength

Name

Oxlumo 94.5 mg / 0.5 ml, Injektionslösung

Field of application

Oxlumo wird zur Behandlung der primären Hyperoxalurie Typ 1 (PH1) in allen Altersgruppen angewendet

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680682390014

Trade status*

In trade from / since 3/28/2022

Status

A/R – Authorised / referenced

Package size

1 vial(s)

Application type

SUBC – Subcutaneous use

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

94.5 mg lumasiranum
lumasiranum natricum

Excipient

aqua ad iniectabile
acidum phosphoricum
natrii hydroxidum
nitrogenium

Authorisation holder

GLN**

7601001408906

Address

Alnylam Switzerland GmbH
Grafenauweg 4
6300 Zug (ZG)

Date of revision of the text

2/17/2026

Information for prof.

Leaflet

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Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.