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Regulatory & Legal Archive
17-11-2017 EMA: CHMP adopted a positive opinion for Fasenra (benralizumab) 30-mg solution for injection in pre-filled syringes from AstraZeneca AB.
17-11-2017 EMA: CHMP adopted a positive opinion for Ocrevus (ocrelizumab) 300-mg concentrate for solution for infusion from Roche Registration Limited.
17-11-2017 MoH: Draft Order for completing the Order of the Minister of Health 449/2015 on the approval of the administration, financing and implementation of priority actions for the treatment of patients with acute myocardial infarction.
17-11-2017 EMA: CHMP adopted a positive opinion for Intrarosa (prasterone) 6.5 mg pessary from Endoceutics Ltd.
16-11-2017 MoH: Draft of Government` Emergency Ordinance amending and supplementing Law 95/2006 on Health Reform
13-11-2017 EMA: CHMP adopted a positive opinion recommending a change to terms of MA for Genvoya (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide) tablets (150 mg/ 150 mg/ 200 mg/ 10 mg) from Gilead Sciences International Ltd.
13-11-2017 EMA: CHMP adopted a positive opinion for Prevymis (letermovir) film-coated tablets (240 mg and 480 mg) from Merck Sharp & Dohme Limited.
03-11-2017 NMA: EMA press release on PRAC recommendation to introduce additional restrictions on the use of Zinbryta (daclizumab) in the treatment of multiple sclerosis due to the risk of serious liver injury.
03-11-2017 NMA: EMA press release on triggering re-evaluation of solutions for infusion containing hydroxyethyl-starch (HES)
02-11-2017 MoH: Order 1.212/979/2017 for amending and completing the MoH Order and of the President of NHIH Order 3/1/2015 on the contract model, the negotiation methodology, the conclusion and the monitoring of the implementation and execution of the cost-volume / cost-volume-result contracts.
02-11-2017 MoH: Order 1.203 of October 16, 2017 to amend the MoH Order 2.071 / 2008 approving the Procedure for notification of proficiency testing schemes for medical analysis laboratories
02-11-2017 MoH: Order 871/1.300/104/2017 for amending Annexes 1 and 2 of the Order of the Minister of Health, of the Minister of Environment and Forests and of the President of the National Sanitary Authority and Food Safety Authority 637/2.492/50/2012 regarding the approval of the members of the National Commission for Biocidal Products and its Regulation for organization and functioning.
02-11-2017 MoH: Order 1.202 of 16 October 2017 on the establishment, organization and functioning of the Specialized Committees and Subcommittees of the Ministry of Health
01-11-2017 EMA: On the 18 September 2017, the European Commission granted a Marketing Authorisation for Bavencio (avelumab), indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).The Marketing Authorization Holder for this medicinal product is Merck Serono Europe
01-11-2017 EMA: On the 27 September 2017, the European Commission granted a Marketing Authorisation for Dupixent (dupilumab), indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The Marketing Authorization Holder for this medicinal product is sanofi-aventis groupe.
01-11-2017 EMA: On the 18 September 2017, the European Commission granted a Marketing Authorisation for Rydapt (midostaurin), indicated: - in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive. - as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL). The Marketing Authorization Holder for this medicinal product is Novartis Europharm Ltd.
01-11-2017 EMA: On the 18 September 2017, the European Commission granted a Marketing Authorisation for Xermelo (telotristat ethyl), indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. The Marketing Authorization Holder for this medicinal product is Ipsen Pharma.
31-10-2017 EMA: Human medicines European public assessment report (EPAR): Viekirax (ombitasvir / paritaprevir / ritonavir) - Revision: 9 - Authorised
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