Halaven was also studied in 143 patients with liposarcoma who had previously undergone at least two other treatments, which included an anthracycline. The main measures of effectiveness were overall survival and progression-free survival (how long the patients lived without their disease getting worse). The study compared Halaven with capecitabine (another cancer medicine). The second study involved 1,102 patients with advanced or metastatic breast cancer, with one or two previous treatments for advanced/metastatic cancer including an anthracycline and a taxane. The main measure of effectiveness was overall survival (how long the patients lived). The women were given either Halaven or another approved cancer medicine chosen by their doctor. In the first study, Halaven was compared with other treatments in 762 women with advanced or metastatic breast cancer, who had previously undergone at least two other treatments, which included an anthracycline and a taxane. 'Third party' refers to any natural or legal person, or any entity outside the Agency, including the Member States, other Community or non-Community institutions and bodies and third countries.In breast cancer, Halaven was studied in two main studies involving a total of 1,864 patients.'Redacted documents' are documents that, in their original form, contain sensitive information (such as CCI or PPD) and which information must be blacked out before access to these documents may be granted.'Protected Personal Data' (PPD) refers to protected data related to a living individual who can be identified from that data.' Commercially Confidential Information' (CCI) refers to the safeguarding of the privacy of sensitive information.'Public': information that is not classified as either restricted or confidential.Rules for the implementation of Regulation (EC) No 1049/2001 on Access to documents Documents are classified 'confidential' if they fall under any of the exceptions laid down in Article 3 of the 'Confidential': information whose unauthorised disclosure could harm the essential interests of the EU Institutions, the Member States and/or the Agency.Rules for the implementation of Regulation (EC) No 1049/2001Īnd their premature disclosure might be prejudicial to the interests of the Agency Documents are classified 'restricted' if they fall into any of the categories listed Article 3 of the 'Restricted': information whose unauthorised disclosure at the time of an access-to-documents request could be disadvantageous to the interests of the EU Institutions, the Member States and/or the Agency, but which may be made available to the public in the future.'Document' means any content regardless of its medium (a written document stored electronically or on paper, or an audio, video or audio-visual recording) concerning a matter relating to the policies, activities and decisions falling within the Agency's area of responsibility.Overview of comments on the output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use.Overview of comments received on the output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use.Overview of comments received on the European Medicines Agency draft policy on access to documents.The revised policy takes into account stakeholder recommendations provided during a public consultation held in 2017: Output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use.Output of the European Medicines Agency policy on access to documents related to medicinal products for human and veterinary use.The policy is accompanied by two output tables outlining access rules for specific document types: European Medicines Agency policy on access to documents.EMA's policy on access to documents describes the rules the Agency applies to grant access to the documents it holds on human and veterinary medicines and documents not related to medicines.ĮMA revised the policy in October 2018 based on its experience implementing the policy since it was introduced in 2010. The revisions update the provisions for medicines-related documents and also extend the policy's scope to documents that are not related to medicines:

Ema menu