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Re: Jonjones325 post# 454805

Saturday, 03/23/2024 2:30:17 PM

Saturday, March 23, 2024 2:30:17 PM

Post# of 517128
Anavex had no choice in going with the Centralized Marketing Procedure. It is compulsory for drugs that treat neurodegenerative diseases.

That is not to minimize the importance of obtaining the go ahead.

1. Centralised authorisation procedure
This procedure results in a single marketing authorisation that is valid in all European Union countries, as well as in Iceland, Liechtenstein and Norway.

The centralised procedure is compulsory for new marketing-authorisation applications for medicines for human use in the following cases:

human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions, and viral diseases;
medicines derived from biotechnology processes, such as genetic engineering;
advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines;
officially designated 'orphan medicines' (medicines used for rare human diseases);


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