Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing...

Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring...

transformed into a marketing authorisation valid for the whole of the EU. A special type of approval is the paediatric-use marketing authorisation (PUMA), which...

Paediatric-use marketing authorisations (PUMA) are granted by the European Medicines Agency (EMA) for medical products that are intended exclusively for...

Court upheld PharmaMar's appeal and annulled the decision refusing marketing authorisation for Aplidin, and the European Commission then returned the application...

Retrieved 16 November 2020. "EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine" (Press release). European Medicines...

use in cattle throughout the European Union, via a centralised marketing authorisation. 2006: The first generic meloxicam product was approved. 2024 (January):...

of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system)...

abuse. In 2011, the European Medicines Agency (EMA) granted a marketing authorisation for a buccal application form of midazolam, sold under the brand...

received marketing authorisation for pediatric ADHD from the FDA, becoming "the first game-based therapeutic granted marketing authorisation by the FDA...

2017. Retrieved 28 March 2017. "Pegloticase: withdrawal of its EU marketing authorisation is welcome". Prescrire International. 26 (180): 71. March 2017...

Kingdom's (NHS as of September 2016[update]) after being given marketing authorisation by European Commission on the advice of the European Medicines...

conditional marketing authorisation within days. On 29 January 2021, the EMA recommended granting a conditional marketing authorisation for AZD1222 for...

conclusions and grounds for the variation to the terms of the marketing authorisation(s)" (PDF) (data sheet). European Medicines Agency. April 6, 2017...

Australia's Therapeutic Goods Administration (TGA) in 2021. A marketing authorisation application for 68Ga-PSMA-11 (INN Gallium (68Ga) gozetotide), under...

original marketing authorisation holder relating to (pre-) clinical testing is protected. Accordingly, in relation to marketing authorisation applications...

the European Medicines Agency recommended the refusal of the marketing authorisation for the medicinal product, intended for the treatment of anorexia...

a group recovery program aimed at marijuana addiction Marketing authorisation, an authorisation granted by a regulatory authority to market a new drug...

marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation as...

conclusions and grounds for the variation to the terms of the Marketing Authorisation(s)" (PDF). European Medicines Agency. August 2017. Retrieved 17...

2007 [Guideline on Excipients in the Dossier for Application for Marketing Authorisation of a Medicinal Product] Food: The Chemistry of Its Components....

which is in the public domain. "Kisqali - opinion on variation to marketing authorisation". European Medicines Agency (EMA). 17 October 2024. Retrieved 27...

Retrieved 7 April 2019. "Sepracor Pharmaceuticals Ltd withdraws its marketing authorisation application for Lunivia (eszopiclone)". European Medicines Agency...

In May 2000, the FDA withdrew marketing authorisation for trovafloxacin. Trovafloxacin received marketing authorisation in the European Union in October...

modulator of apoptosis (PUMA), a pro-apoptotic protein Paediatric-use marketing authorisation (PUMA), by the European Medicines Agency PUMA experiment, an experiment...

Medicines Agency - - Sepracor Pharmaceuticals Ltd withdraws its marketing authorisation application for Lunivia (eszopiclone)". www.ema.europa.eu. 17 September...

health, and is part of the regulatory requirements for obtaining a Marketing Authorisation (MA) for a medicinal (human or veterinary) product. The quality...

allergic reaction to it. When the drug's manufacturer has received a marketing authorisation from the government agency, then it is allowed to promote the drug...

responsible for: the assessment, issue and maintenance of all national Marketing Authorisations for veterinary medicines in accordance with European Community...

"Questions and answers on the recommendation for the refusal of the marketing authorisation for Milnacipran Pierre Fabre Médicament/Impulsor" (PDF). European...