SAI - Detailed view

NALTREXIN Filmtabl 50 mg 28 Stk

Drug

Name

Naltrexin, Filmtabletten

Field of application

Opiat-Antagonist zur Entwöhnung nach erfolgter Entgiftung von Opiatabhängigen, von Alkoholabhängigen.

ATC

N07BB04 - NALTREXONE

15.01.1. – morphine antagonists

Use

HAM – Human medicine

pharmaceutical form

FILM – Film-coated tablet

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

56109

Initial registration date

4/22/2003

Expiry date

12/31/9999

Dosage strength

Name

Naltrexin, Filmtabletten

Field of application

Opiat-Antagonist zur Entwöhnung nach erfolgter Entgiftung von Opiatabhängigen, von Alkoholabhängigen.

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680561090028

Trade status*

In trade from / since 4/22/2003

Status

A/R – Authorised / referenced

Package size

28 tablet(s)

Package code

002

Authorisation status

Z – approved

Declaration

Component

Active substance

50.000 mg naltrexoni hydrochloridum
45.2 mg naltrexonum

Excipient

123.155 mg lactosum monohydricum
cellulosi pulvis
cellulosum microcristallinum
silica colloidalis anhydrica
crospovidonum
magnesii stearas
3.600 mg lactosum monohydricum
hypromellosum
E 171
macrogolum 4000
E 172 (nigrum)
E 172 (rubrum)
E 172 (flavum)