ORSERDU cpr pell 86 mg 28 pce

7680694170017 CH-69417 L02BA04 07.16.2.
ORSERDU cpr pell 86 mg 28 pce
ORSERDU cpr pell 86 mg 28 pce
ORSERDU cpr pell 86 mg 28 pce
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Details

Product number
6941701
CPT
-
Packaging group
28
Unit
Tablette(n)
Composition
Filmtablette: elacestrantum 86 mg ut elacestranti dihydrochloridum, cellulosum microcristallinum, crospovidonum, magnesii stearas, silica colloidalis anhydrica, Überzug: poly(alcohol vinylicus), E 171, macrogolum 3350, talcum, E 133, pro compresso obducto.

Articles (1)

Orserdu 86 mg, Filmtabletten
Filmtabletten
28
View

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
Professional SmPC
Allemand
21/06/2024
Professional SmPC
Français
21/06/2024
Professional SmPC
Italien
21/06/2024

Detailed composition

Substance Quantity Type Category
FTAB
86.0 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 2434.55
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
Dispensation 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.

Packaging details

Description (FR)
ORSERDU cpr pell 86 mg 28 pce
Description (DE)
ORSERDU Filmtabl 86 mg 28 Stk
Market launch
04/06/2024
Narcotic (BTM)
No

Other packaging sizes

ORSERDU cpr pell 345 mg 28 pce
28 TABL
View