It will be routinely updated at least once a year as new or amended SPCs are produced. First antibody-drug conjugate for multiple myeloma patients with limited treatment options. Presumably, the company should point this out to the EMA at the email listed for correspondence (Are there any implications for the Investigator Brochure if the approved drug is being used in clinical trials also?Can companies “ignore” or not use this database if they so choose?Should it be used in the preparation of RMPs and PSURs/PBRERs? Might a company now have more cases that are expedited in the EMA and not in the US or vice versa?Should a company now match up this database with their own? This complements information on medicines published on EMA's website, which only includes medicines EMA evaluates. This site uses cookies so that we can provide you with better user experiences, analyze the traffic to our website, and assist with our marketing efforts. Use the MHRA Yellow Card scheme to report any suspected problems or incidents with healthcare products and devices, as well as reporting side effects to medicines. For help on how to get the results you want, see our Apply European public assessment reports (EPAR) filter Apply Periodic safety update report single assessments filter Apply Direct healthcare professional communication filter This page searches the Orphan Drug Product designation database. It may be a large effort for a big company to check their own list vs the EMA’s.If this is now a “semi-official” database and it differs from how a company has done expected/unexpected this may produce problems. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Click for detailed instructions. Access the database. This field is for validation purposes and should be left unchanged. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. Search by disease name: Enter your requested disease name to access the list of medicinal products for this disease. The EMA operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Unionand its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. EMA is in the process of making appropriate changes to this website. © 2020 C3i. See: It is called the Protect Database and was developed by the EMA and some partners. If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. Results can be displayed as a condensed list, detailed list, or an Excel spreadsheet. Are some cases which were considered by the company to be expected now considered unexpected based on this database? Searches may be run by entering the product name, orphan designation, and dates.

Staying Up to Date is Vital. Active ingredients, ATC levels, administration routes, strength, trade names, MA holder information, real manufacturer information, leaflets in PDF format and much more. The Experience Matters. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. The EMA operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. The decision on the relocation was made on 20 November 2017, during the EU It is unclear what future arrangements the United Kingdom proposes to make for its own medicinal evaluation after leaving the EU. Search the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. The biggest issue will occur when there was not a direct mapping of the SPC ADR to MedDRA.So what should a company do? In February 2013 the EMA released a new Adverse Drug Reaction (ADR) database. Search dm+d browser . Under this legislation, all applications for A seventh committee, the Pharmacovigilance Risk Assessment Committee (PRAC) has come into function in 2012 with the implementation of the new EU pharmacovigilance legislation (Directive 2010/84/EU).The Agency carries out a number of activities, including: * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). For more information on the different medicine authorisation routes in the EU, see Please note that the information in these national registers may not be available in English. It consists of all ADRs listed in section 4.8 (Undesirable Effects) of the Summary of Product Characteristics (SPC) for all centrally approved products. The likelihood of this is small but with tens of thousands of terms that are drug specific, this will undoubtedly occur. Additional updates will be done to correct errors.It is based on MedDRA PTs though LLTs may also be used if further precision is required.