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SAI - Detailed view
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GAVRETO Kaps 100 mg Fl 120 Stk
Drug
Gavreto, Hartkapseln
Nichtkleinzelliges Lungenkarzinom mit Rearrangement des RET (Rearranged during Transfection)-Gens; Schilddrüsenkarzinome mit RET-Fusion oder RET-Mutation
07.16.1. – cytostatics
HAM – Human medicine
KAHA – Capsule, hard
S – synthetic products for human use
A – Dispensed once only on prescription by a physician or veterinarian (A)
B – limited
8/12/2021
9/12/2023
Dosage strength
Gavreto 100 mg, Hartkapseln
Nichtkleinzelliges Lungenkarzinom mit Rearrangement des RET (Rearranged during Transfection)-Gens; Schilddrüsenkarzinome mit RET-Fusion oder RET-Mutation
01
B – limited
Package
7680681820017
Out of trade from / since 8/12/2023
NA – No longer authorised
120 capsule(s)
001
B – limited
Declaration
Component
100 mg pralsetinibum
hypromellosum
cellulosum microcristallinum
natrii hydrogenocarbonas
22.3 mg natrium
acidum citricum
magnesii stearas
amylum pregelificatum
hypromellosum
E 171
E 133
lacca
propylenglycolum
ammonii hydroxidum
kalii hydroxidum
E 171
cellulosum microcristallinum
natrii hydrogenocarbonas
22.3 mg natrium
acidum citricum
magnesii stearas
amylum pregelificatum
hypromellosum
E 171
E 133
lacca
propylenglycolum
ammonii hydroxidum
kalii hydroxidum
E 171
Spezialitätenliste***
SL
-
-
7839.80
None
Yes
10%
No
Authorisation holder
7601001010208
Roche Pharma (Schweiz) AG
Gartenstrasse 9
4052 Basel (BS)
Gartenstrasse 9
4052 Basel (BS)
Date of revision of the text
9/1/2023
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Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.