SAI - Detailed view

CRESEMBA Kaps 100 mg 14 Stk

Drug

Name

Cresemba, Hartkapseln

Field of application

Antimykotikum

ATC

J02AC05 - ISAVUCONAZOLE

08.06.0. – antifungals

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

Z – approved

Authorisation number

66172

Initial registration date

10/20/2017

Expiry date

12/31/9999

Dosage strength

Name

Cresemba 100 mg, Hartkapseln

Field of application

Antimykotikum

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680661720016

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

14 capsule(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

100 mg isavuconazonium
isavuconazonii sulfas

Excipient

magnesii citras
cellulosum microcristallinum
talcum
silica colloidalis anhydrica
acidum stearicum
hypromellosum
E 172 (rubrum)
E 171
gellani gummi
kalii acetas
dinatrii edetas
natrii laurilsulfas
lacca
propylenglycolum
ammoniae solutio concentrata
E 172 (nigrum)
kalii hydroxidum
ca. 0.2 mg natrium