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You can download the European Medicines Agency's (EMA)?medicine-related data published on this website?in Excel table format from this page. EMA updates these medicine data tables once a day. For more information on what type of information?EMA publishes on medicines, see What we publish on medicines and when. European public assessment reports (EPAR) Pending EC decisions: summaries of opinion When a pharmaceutical company applies for marketing authorisation through the centralised authorisation procedure, the?CHMP?or?CVMP?gives a positive or negative recommendation, in the form of a scientific opinion, on whether a medicine should be authorised. Immediately after the opinion is adopted, EMA publishes a 'summary of opinion'. This summary is replaced by a full?European public assessment reports?once the European Commission has decided - taking the EMA opinion into consideration - whether to grant the?marketing authorisation. EMA also publishes summaries of opinion?when the?CHMP?or?CVMP?adopts scientific opinions on?important changes to an existing?marketing authorisation?applied for by the marketing authorisation holder. Download table of all summaries of opinions for human and veterinary medicines Alternatively, search for: Human medicines: summaries of opinion Veterinary medicines: summaries of opinion Paediatric investigation plans Rare disease (orphan) designations An?orphan designation?allows a pharmaceutical company to benefit from incentives from the European Union to develop a medicine for a rare disease, such as reduced fees and protection from competition once the medicine is placed on the market. Applications for?orphan designation?are examined by EMA's Committee for Orphan Medicinal Products?(COMP), which adopts an opinion that is forwarded to the European Commission. The European Commission then decides whether to grant an?orphan designation?for the medicine in question. Download table of all orphan designations Alternatively, you can search: Orphan?designations For more information, see Orphan designation. Periodic safety update report single assessments (PSUSAs) A periodic safety update report (PSUR) is a?pharmacovigilance?report submitted regularly by a marketing-authorisation holder at defined time points following a medicine's authorisation. A?single assessment of related PSURs?is carried out for medicines that contain the same?active substance?or combination of?active substances, as included in the?list of EU reference dates?(EURD list). EMA's scientific committees (PRAC?and?CHMP) and the?CMDh?together with the lead Member State assess the information in the related PSURs to determine whether the balance of benefits and risks has changed and whether any updates should be made to the?marketing authorisation. EMA publishes the lists of nationally authorised medicines involved in PSUR single assessments for?active substances?contained only in?nationally authorised?medicines, together with the outcomes of assessments that lead to a?variation?of?marketing authorisations. Download table of lists of nationally authorised medicines involved in PSUR single assessments and regulatory outcomes Alternatively, you can search: Periodic safety update reports single assessments The outcomes of PSUR assessments for?active substances?found only in centrally authorised?medicines are published as part of each medicine's?European public assessment report (EPAR). The outcome for nationally authorised?medicinal products?included in 'mixed' procedures where?centrally authorised products?were also involved can be found on the Community register maintained by the European Commission. For more information, see Periodic safety update reports: questions and answers. Regulatory outcomes When a PSUR single assessment procedure leads to a?variation?of?marketing authorisations, marketing-authorisation holders for?nationally authorised products?containing the?active substance(s) concerned should submit a?variation?to align their?marketing authorisation?with the single assessment outcome, even if their product was not in the direct scope of the procedure (such as a?generic medicine?or a medicine authorised on the basis of well established use). This is in line with Article 23 of Directive 2001/83/EC and Article 16 of regulation (EC) No 726/2004. Documents presenting 'CMDh?scientific conclusions and grounds for the?variation, amendments to the?product information?and timetable for the implementation' contain all language versions within a single PDF file if they were published before 17 October 2016. EMA's Committee on Herbal Medicinal Products (HMPC) compiles?and assesses?scientific data on herbal substances, preparations and combinations, to support the harmonisation of herbal products on the EU?market. Multiple documents may be associated with a herbal?substance, depending on?where it is in the assessment process. The?HMPC's conclusions on a substance at the end of the assessment process are included?in the final European Union herbal monographs and list?entries. Download table of herbal medicines Alternatively, you can search: Herbal medicines (for searching substances assessed in combination, include?'combination' in the Latin name of the genus or the botanical name of the plant) For more information, see Herbal medicinal products.
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Download Full emma daumas. Emma right after she wakes up: “bitchhh. I need a nap”. Like si Emma canta hermoso?? Happy happy?. Download full mame romset. Download Full emmaus. Research and development Pharmaceutical and biotechnology companies, doctors and academics research new medicines. READ MORE + Who does initial research on medicines? Tens of thousands of substances are investigated every year by pharmaceutical and biotechnology companies, as well as doctors and academics, for their potential to treat diseases. Only a small number will ever be promising enough to be tested in patients and just a fraction of these will ever have study results good enough to reach the market. Developers of innovative treatments can discuss the scientific, legal and regulatory aspects of their medicine with EMA early in the development through the Innovation Task force. In 2018, 9 of 22 such requests for early discussions came from university-based or academic groups. Read more about how potential new medicines are tested Can EMA influence which medicines should be developed? EMA cannot compel companies to research particular medicines for a particular condition. However, EMA does publicise areas where there is a need for new medicines to encourage interested parties to research them. Read more.
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