Category: Pharmaceutical regulations

According to the European Medicines Agency (EMA), manufacturer Wyeth voluntarily withdrew its applications for Pristiq (desvenlafaxine) in Europe in 2008 after regulators expressed concerns over the drug's efficacy and risk-benefit profile. This was a withdrawal of applications for marketing authorization, not a ban, and it is the key reason **why did Europe ban Pristiq** is a misconception.

Established in the early 1990s to harmonize pharmaceutical oversight, EudraLex is the official compilation of rules governing medicinal products within the European Union (EU). This extensive collection of legislation and guidelines is mandatory for any company seeking market access in the EU pharmaceutical ecosystem, ensuring products meet stringent safety, efficacy, and quality standards.