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; Schilddrüsenkarzinome mit RET-Fusion oder RET-Mutation

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

9/12/2023

Dosage strength

Name

Gavreto 100 mg, Hartkapseln

Field of application

Nichtkleinzelliges Lungenkarzinom mit Rearrangement des RET (Rearranged during Transfection)-Gens; Schilddrüsenkarzinome mit RET-Fusion oder RET-Mutation

Dosage strength number

Authorisation status

B – limited

Package

GTIN**

7680681820017

Trade status*

Out of trade from / since 8/12/2023

Status

NA – No longer authorised

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