Orserdu 345 mg, Filmtabletten

7680694170024 CH-69417 Filmtabletten
Orserdu 345 mg, Filmtabletten
Orserdu 345 mg, Filmtabletten
Orserdu 345 mg, Filmtabletten
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Article details

Package size
28
Selling units
28
Measure
Tablette(n)
Galenic form
Filmtabletten
Galenic group
Tabletten

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
21/06/2024
Patient information leaflet
Français
21/06/2024
Patient information leaflet
Italien
21/06/2024
Summary of Product Characteristics
Allemand
21/06/2024
Summary of Product Characteristics
Français
21/06/2024
Summary of Product Characteristics
Italien
21/06/2024

Detailed composition

Substance Quantity Type Category
FTAB
345.0 MG Substance Wirkstoff (Principe actif)
FTAB
- Substance WIZUS
FTAB
- Substance HNIDK
FTAB
- Substance HNIDK
FTAB
- Substance HNIDK
FTAB
- Substance HNIDK
FTAB
- Substance HNIDK
FTAB
- Substance FNIDK
FTAB
- Substance HNIDK
FTAB
- Substance HNIDK
FTAB
- Substance FIMDK

Reimbursement information

Public price
CHF 7608.30
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/09/2025

Authorization holder

Stemline Therapeutics Switzerland GmbH

6300 Zug

Authorization information

Swissmedic authorization number
69417
Drug name
Orserdu, Filmtabletten
Galenic form
FILM
ATC Code
L02BA04
Authorization status
Z
Dispensing category
B
First authorization
04/06/2024
Authorization expiration date
03/06/2029
IT Number
07.16.2.
Domain
Human medicine
Field of application
Als Monotherapie zur Behandlung von postmenopausalen Frauen mit Estrogenrezeptor (ER) positivem, HER2-negativem, lokal fortgeschrittenem oder metastasiertem Brustkrebs mit einer aktivierenden ESR1-Mutation, deren Erkrankung nach mindestens einer endokrinen Therapielinie, kombiniert mit einem CDK 4/6-Inhibitor, fortgeschritten ist.

Package details

Description (FR)
ORSERDU cpr pell 345 mg 28 pce
Description (DE)
ORSERDU Filmtabl 345 mg 28 Stk
Market launch
04/06/2024
Narcotic (BTM)
No

Other package sizes (1)

ORSERDU cpr pell 86 mg 28 pce
28 TABL
GTIN: 7680694170017
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