SAI - Detailed view

ABIRATERON Accord Filmtabl 500 mg 56 Stk

Drug

Name

Abirateron Accord, Filmtabletten

Field of application

Prostatakarzinom

ATC

L02BX03 - ABIRATERONE

07.16.2. – hormones

Use

HAM – Human medicine

pharmaceutical form

FILM – Film-coated tablet

Remedy code

S – synthetic products for human use

Dispensing categories

B – Dispensed on prescription by a physician or veterinarian (B)

Authorisation status

Z – approved

Authorisation number

67950

Initial registration date

1/14/2022

Expiry date

1/13/2027

Dosage strength

Name

Abirateron Accord 500 mg, Filmtabletten

Field of application

Prostatakarzinom

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680679500013

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

56 tablet(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

500 mg abirateroni acetas
446 mg abirateronum

Excipient

253.2 mg lactosum monohydricum
cellulosum microcristallinum
carmellosum natricum conexum
hypromellosum
natrii laurilsulfas
silica colloidalis anhydrica
magnesii stearas
poly(alcohol vinylicus)
E 171
macrogolum 3350
talcum
E 172 (rubrum)
E 172 (nigrum)
12.24 mg natrium