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SAI - Detailed view

NUBEQA Filmtabl 300 mg 112 Stk

Drug

NUBEQA, Filmtabletten
nicht-metastasiertes, kastrationsresistentes Prostatakarzinom (nmCRPC); metastasiertes, hormon-sensitives Prostatakarzinom (mHSPC)
07.16.2. – hormones

HAM – Human medicine
FILM – Film-coated tablet
S – synthetic products for human use
B – Dispensed on prescription by a physician or veterinarian (B)

Z – approved
6/19/2020
6/18/2025

Dosage strength

NUBEQA 300 mg, Filmtabletten
nicht-metastasiertes, kastrationsresistentes Prostatakarzinom (nmCRPC); metastasiertes, hormon-sensitives Prostatakarzinom (mHSPC)
01
Z – approved

Package

7680675210015
No information made available
A/R – Authorised / referenced 

112 tablet(s)

001
Z – approved

Declaration

Component

300 mg darolutamidum
calcii hydrogenophosphas
carmellosum natricum conexum
2.7 mg natrium
lactosum monohydricum
magnesii stearas
povidonum K 30
hypromellosum
lactosum monohydricum
macrogolum 3350
E 171
186 mg lactosum monohydricum

Spezialitätenliste***

SL
-
-
3392.05
None
Yes
10%
No

Authorisation holder

7601001002593
Bayer (Schweiz) AG
Uetlibergstrasse 132
8045 Zürich (ZH)

Date of revision of the text

1/4/2024

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