EN SV HOME THERAPEUTIC AREAS RESEARCH & DEVELOPMENT MANAGED ACCESS PROGRAMMES Managed Access Programmes There may be circumstances where no satisfactory alternatives exist for the treatment of a patient with a life threatening or seriously debilitating disease/condition and where enrolment in a clinical trial is not possible. In such circumstances, the treating physician may wish to provide their patients with an investigational medicine which has not yet been approved by regulatory authorities. Background Evaluation of medicinal products in clinical trials Before a medicinal product becomes available on the market, it must undergo a clinical trial programme to establish its safety and efficacy profile. Review of the clinical trial results by the relevant health authorities may then lead to approval and marketing authorization of the product. Please find a list of Sobi’s ongoing clinical programmes here. Managed Access There may be instances where a patient has a life threatening or seriously debilitating disease/condition and all available treatment options are exhausted and enrolment into a clinical trial is not possible. In such a situation, the patient’s treating physician may be able to request access to an investigational medicine prior to regulatory approval, provided this is permitted by applicable local laws and regulations. Sobi has a process in place, referred to as “Managed Access Programmes” through which certain treatments can be made available to eligible patients, provided specific criteria and requirements are met. There are several different terms that fall within Managed Access, these include Compassionate Use, Named Patient Use, Individual Patient Request amongst others. Terms used may differ from country to country depending on local laws and regulations. Types of Managed Access in Sobi Submit Managed Access request If you are a treating physician who would like to submit a Managed Access request for a Sobi investigational medicine for a patient, please use the Sobi Managed Access Portal. You will need to create a profile and upload your CV before you can submit your request. SOBI MANAGED ACCESS PORTAL SOBI MA PORTAL SUPPORT Sobi MA Portal Support 805 KB About us At a glance Rare diseases Therapeutic areas Haematology Immunology Specialty Care portfolio Investors Reports & presentations Share information Calendar Career Open positions Meet our employees Media Press releases Gallery Sobiplay Sitemap Cookie Policy Privacy Policy Terms of use Cookies Settings © Swedish Orphan Biovitrum AB (publ) Reg. no. 556038-9321