Regulatory & Legal Archive
24-07-2017 EMA: On the 23 June 2017, the European Commission granted a Marketing Authorization for Skilarence (dimethyl fumarate), indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. The applicant for this medicinal product is Almirall S.A.
24-07-2017 EMA: On the 29 June 2017, the European Commission granted a Marketing Authorization for Besponsa (inotuzumab ozogamicin), indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI). The applicant for this medicinal product is Pfizer Limited.
12-07-2017 MoH: Draft Order for the amendment and completion of Annex 2 of the MoH and NHIH Order 1.605 / 875/2014 approving the calculation method, the list of the trade names and the settlement prices of the medicinal products granted to the patients under the National Health Programs and the methodology for their calculation
06-07-2017 EMA: On 23 June 2017, the European Commission granted a Marketing Authorization for Kevzara (sarilumab) in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). The applicant for this medicinal product is sanofi-aventis groupe.
06-07-2017 EMA: On 22 May 2017, the European Commission granted a Marketing Authorization for Axumin (fluciclovine (18F)), indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. The applicant for this medicinal product is Blue Earth Diagnostics Ltd.
03-07-2017 MoH: GD on the completion of the GD 720 of2008 for the approval of the list of INNs for medicinal products benefited by insured persons, with or without a personal contribution, on a medical prescription, in the Health Insurance System, as well as the INNs of medicinal products granted under the National Health Programs.
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