![]() Requests to submit an application for a duplicate should be sent to the Commission (via Notice on handling of duplicate marketing authorisation applications (March 2021) However, in specific cases a company may apply for a duplicate marketing authorisation. Under the centralised procedure, a company may only obtain one marketing authorisation per medicinal product. For which an EU authorisation would be in the interest of patients.Constituting a significant therapeutic scientific or technical innovation, or.That contain an active substance not authorised before ,.It can also apply to all medicinal products: Medicinal products for human use which contain an active substance authorised in the Union after and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders or diabetes. ![]() The centralised procedure is laid down in Regulation (EC) No 726/2004 compulsory for: ![]() Such authorisation is granted by the European Commission following the scientific assessment of the application by the European Medicines Agency. While the drug is yet to be sold in the UK, the government announced last month that it was looking into making it more widely available than originally planned through a pilot program aimed at expanding weight loss services.Marketing authorisations granted under the "centralised procedure" allow the marketing-authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation. Wegovy is currently available in the US, Denmark and Norway and is scheduled to hit the market in Germany this month. Ozempic is approved for use by people with type 2 diabetes and uses the same active ingredient, semaglutide, as Wegovy, which is licensed for use. Saxenda, which uses the active ingredient liraglutide, is a weight loss medication that was first approved in 2014. “GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and to treat obesity for eight years, including Novo products such as semaglutide and liraglutide that have been on the market for more than 10 years,” a company spokesperson said. Novo said in a statement that patient safety is a “top priority” and that it takes all reports of adverse events very seriously. The European Medicines Agency said it would consider whether to expand its review to include other medicines in the same class, known as GLP-1 receptor agonists. The proliferation of medicines has led to shortages in supplies and delays in introducing medicines to new markets. Novo has exploded into the spotlight over the past two years after Wegovy and its sugar sister drug Ozempic were found to lead to significant weight loss for people, with celebrities and high-profile business figures openly discussing their use of them. The newer Novo weight loss drug Wegovy also contains semaglutide. ![]() The agency is investigating possible side effects in patients who have used drugs containing the active ingredients semaglutide or liraglutide for weight loss. An additional issue of thoughts of self-harm was raised in relation to Saxenda. The European Medicines Agency said in a statement on Monday that the European Medicines Agency is looking into the adverse events indicated by the Icelandic Medicines Agency, including two cases of suicidal thoughts linked to the drugs Saxenda and Ozempic. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |