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SAI - Detailed view
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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
12/31/9999
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
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
-
-
3203.20
None
Yes
10%
No
Authorisation holder
7601001002593
Bayer (Schweiz) AG
Uetlibergstrasse 132
8045 Zürich (ZH)
Uetlibergstrasse 132
8045 Zürich (ZH)
Date of revision of the text
10/4/2024
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Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.