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Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.
As of 2016, the EMA was roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA), [53] but without centralisation. [54] The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate a product. [55]
Still used as veterinary drug and as a human antihelminthic in many markets; listed on the WHO List of Essential Medicines. In humans, it was used to treat melanoma before it was withdrawn for agranulocytosis. [29] [30] [31] Levomethadyl acetate: 2003 US Cardiac arrhythmias and cardiac arrest. [2] Lorcaserin (Belviq) 2020 US Increased risk of ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
It was approved for medical use in the European Union in September 2023. [5] The EMA granted orphan drug designation to epcoritamab in both February and June 2022. [ 15 ] [ 16 ] [ 17 ]
Many drugs have more than one name and, therefore, the same drug may be listed more than once. Brand names and generic names are differentiated by capitalizing brand names. See also the list of the top 100 bestselling branded drugs , ranked by sales.
List of Antiviral Drugs Antiviral Use Manufacturer Component Type Year approved Abacavir: HIV: ViiV Healthcare: Nucleoside analogue reverse transcriptase inhibitor (NRTI) 1998 Acyclovir (Aciclovir) Herpes Simplex, chickenpox, [2] varicella zoster virus: GSK: guanosine analogue RTI 1981 Adefovir: Hepatitis B [3] Gilead Sciences RTI 2002 , 2003 ...
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