Specifikke, nationale krav, som er aftalt med den kompetente, nationale myndighed angående: o Distribuering af produktet o Sikkerhed for at alle passende foranstaltninger er blevet iværksat, inden at Revlimid ordineres.
The Educational Health Care Professional’ s Kit shall contain the following elements: • Brief background on lenalidomide and its licensed indication • Posology • The need to avoid foetal exposure due to teratogenicity of lenalidomide in animals and the expected teratogenic effect of lenalidomide in humans including a summary of the interim results of study CC-5013-TOX-004 • Obligations of the health care professional in relation to the prescribing of Revlimid