SAI - Detailed view

OSENVELT 120 mg/1.7 ml Inj Lös 120 mg 1 Durchstf

Drug

Name

Osenvelt, solution injectable

ATC

M05BX04 - DENOSUMAB

07.16.1. – cytostatics

Use

HAM – Human medicine

pharmaceutical form

LSINJ – Solution for injection

Remedy code

BT – biological medicines

Dispensing categories

A – Dispensed once only on prescription by a physician or veterinarian (A)

Authorisation status

Z – approved

Authorisation number

70196

Basic authorisation number

61865

Initial registration date

8/19/2025

Expiry date

8/18/2030

Dosage strength

Name

Osenvelt 120 mg/1.7 ml (70 mg/ml), solution injectable

Field of application

Métastases osseuses issues de turneurs solides; tumeurs à cellules géantes de l'os

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680701960013

Trade status*

In trade from / since 2/20/2026

Status

A/R – Authorised / referenced

Package size

1 vial(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

120 mg denosumabum

Excipient

acidum aceticum glaciale
natrii acetas trihydricus
0.5 mg natrium
79.9 mg sorbitolum
polysorbatum 20
aqua ad iniectabile

Authorisation holder

GLN**

7601001402683

Address

IQONE HEALTHCARE SWITZERLAND
route de Suisse 160-162
1290 Versoix (GE)

Date of revision of the text

2/1/2026

Information for prof.

Leaflet

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