Product Information is a key part of the marketing authorisation of all medicines authorised in the European UnionThe SmPC provides the basis of information for healthcare professionals to use a medicine safely, effectively and in the most appropriate manner. It is also a legal document, agreed between the Authorities and the relevant pharmaceutical company.The format and content of the SmPC is laid down in EU/national legislation and regulatory guidance documents. Use of a medicine outside the conditions/ recommendations described in the SmPC falls under the responsibility of the healthcare professional.