Tag: Ema

The World Health Organization (WHO) defines pharmacovigilance, or drug safety monitoring, as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem. It is a continuous process that safeguards public health by ensuring the benefits of a medication outweigh its risks throughout its entire lifecycle.

According to a 2023 study of melatonin supplements in Canada, product content varied wildly, from 83% less to 478% more than the labeled dose. This severe lack of quality control is a primary reason why melatonin is not available over-the-counter in most of Europe, where it is classified as a medicine rather than a dietary supplement.

While major depressive disorder affects millions in Europe, the antidepressant Pristiq is notably absent from the EU-wide market. Contrary to common belief, the answer to 'Why is Pristiq banned in Europe?' is that it isn't—its market application was voluntarily withdrawn by the manufacturer [1.4.1].

Wegovy received marketing authorization valid throughout the European Union on January 6, 2022, following a positive assessment by the European Medicines Agency (EMA). Despite this blanket approval, the question "**Is Wegovy banned in Europe for weight loss?**" frequently arises due to significant variations in national launches, reimbursement policies, and persistent supply challenges across the continent.

Approximately one-third of people with depression do not respond to initial antidepressant medications, highlighting a critical need for new treatments. The latest wave of **new antidepressants in Europe** focuses on novel mechanisms to address this unmet need, moving beyond the traditional serotonin and norepinephrine pathways to offer faster and more effective options, particularly for difficult-to-treat cases.

An estimated 5-10% of adults globally suffer from chronic cough, defined as a cough lasting longer than eight weeks [1.6.6]. For those with this persistent condition, a key question has emerged: **is gefapixant available on prescription** as a potential treatment?

The United States Prescribing Information (USPI) serves a similar function to the EU's Summary of Product Characteristics (SmPC), providing vital drug information for healthcare professionals. While both documents detail a drug's approved usage, safety, and effectiveness, significant differences in format, content, and regulatory oversight mean they are not identical. This article clarifies what is the US equivalent of SmPC and explores the distinctions that affect prescribers and manufacturers alike.

Since 2013, all EU countries have used a black inverted triangle on medicine information leaflets to signify that a drug is under additional monitoring. But **what does the black triangle mean on drugs** and why is this symbol so important for patient safety and ongoing pharmacovigilance efforts?

A 2023 study confirmed that combining thiocolchicoside with an NSAID is effective for acute low back pain. So, **what is the drug Muscoril used for**, and what are the critical safety considerations from regulatory bodies like the European Medicines Agency (EMA)?

N-acetylcysteine (NAC) is on the World Health Organization's List of Essential Medicines, yet its status as a dietary supplement is complex. The question 'Is NAC banned in Europe?' doesn't have a simple yes or no answer, as it depends on a patchwork of national and EU-level regulations.