SAI - Detailed view

GAVRETO Kaps 100 mg Fl 120 Stk

Drug

Name

Gavreto, Hartkapseln

Field of application

Nichtkleinzelliges Lungenkarzinom mit Rearrangement des RET (Rearranged during Transfection)-Gens; RET-Fusion-positives Schilddrüsenkarzinom

ATC

L01EX - OTHER PROTEIN KINASE INHIBITORS

07.16.1. – cytostatics

Use

HAM – Human medicine

pharmaceutical form

KAHA – Capsule, hard

Remedy code

S – synthetic products for human use

Dispensing categories

A – Dispensed once only on prescription by a physician or veterinarian (A)

Authorisation status

B – limited

Authorisation number

68182

Initial registration date

8/12/2021

Expiry date

11/12/2025

Dosage strength

Name

Gavreto 100 mg, Hartkapseln

Field of application

Nichtkleinzelliges Lungenkarzinom mit Rearrangement des RET (Rearranged during Transfection)-Gens; RET-Fusion-positives Schilddrüsenkarzinom

Dosage strength number

Authorisation status

B – limited

Package

GTIN**

7680681820017

Trade status*

Out of trade from / since 8/12/2023

Status

A/R – Authorised / referenced

Package size

120 capsule(s)

Package code

001

Authorisation status

B – limited

Declaration

Component

Active substance

100 mg pralsetinibum

Excipient

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

Spezialitätenliste***

Status

Date of deletion

Compulsory until

Public price (CHF)

6364.55

Limitation points

None

Limitation

Yes

SB Deductible

10%

Generic

Authorisation holder

GLN**

7601001010208

Address

Roche Pharma (Schweiz) AG
Gartenstrasse 9
4052 Basel (BS)

Date of revision of the text

10/4/2023

Information for prof.

Leaflet

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