Indehaveren af markedsføringstilladelsen (MAH) skal inden lanceringen sikre, at alle læger, der forventes at ordinere Siklos, får udleveret en informationspakke, der indeholder følgende: • Behandlingsvejledning for læger • Patientinformationspakke.
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe Siklos are provided with a physician information pack containing the following: • Treatment guide for physicians • Patient information pack