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AI is ubiquitous in most areas nowadays but what good can it do for medicine and the healthcare industry? Atripla New medicine for hereditary rare disease PRAC confirms four-week limit for use of high-strength estradiol creams Omega-3 fatty acid medicines no longer considered effective in preventing heart disease
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Coronavirus disease (COVID-19)

EMA Healthcare Agency
General

Update on treatments and vaccines against COVID-19 under development

EMA Healthcare Agency
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EMA provides recommendations on compassionate use of remdesivir for COVID-19

EMA Healthcare Agency
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020

EMA Healthcare Agency
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  • Allgemein
    AI is ubiquitous in most areas nowadays but what good can it do for medicine and the healthcare industry?
  • HIV and AIDS
    Atripla
  • Neurodegenerative diseases
    New medicine for hereditary rare disease
  • cardiovascular disease
    PRAC confirms four-week limit for use of high-strength estradiol creams
  • General
    Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020
  • General
    EMA provides recommendations on compassionate use of remdesivir for COVID-19
  • General
    Update on treatments and vaccines against COVID-19 under development
  • General
    Coronavirus disease (COVID-19)
  • General
    Coronavirus disease (COVID-19)
  • General
    Update on treatments and vaccines against COVID-19 under development
  • General
    EMA provides recommendations on compassionate use of remdesivir for COVID-19
  • General
    Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020
General

Update on treatments and vaccines against COVID-19 under development

Apr 3, 2020 EMA Healthcare Agency

Supporting the rapid development and approval of effective and safe treatments for and vaccines against COVID-19 is EMA’s top priority…

Allgemein

AI is ubiquitous in most areas nowadays but what good can it do for medicine and the healthcare industry?

Sep 30, 2023 EMA Healthcare Agency

In the last few months, Artificial Intelligence started to become a big thing within many areas, e.g. the creative industry.…

HIV and AIDS

Atripla

Mar 1, 2022 EMA Healthcare Agency

Overview Atripla is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes…

Neurodegenerative diseases

New medicine for hereditary rare disease

Jun 1, 2021 EMA Healthcare Agency

Tegsedi addresses unmet medical need for treatment of hereditary transthyretin amyloidosis The European Medicines Agency’s (EMA) Committee for Medicinal Products…

cardiovascular disease

PRAC confirms four-week limit for use of high-strength estradiol creams

Jan 17, 2021 EMA Healthcare Agency

EMA’s safety committee (PRAC) has confirmed its recommendation to limit the use of high-strength creams containing 100 micrograms/gram (0.01%) of…

cardiovascular disease

Omega-3 fatty acid medicines no longer considered effective in preventing heart disease

Oct 4, 2020 EMA Healthcare Agency

EMA has concluded that omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in…

General

Coronavirus disease (COVID-19)

Apr 3, 2020 EMA Healthcare Agency

Table of contents What’s new Supporting the development of medicines and vaccines Advice on clinical trials Monitoring the impact on…

General

EMA provides recommendations on compassionate use of remdesivir for COVID-19

Apr 2, 2020 EMA Healthcare Agency

During an extraordinary virtual meeting held on 2 April 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the…

General

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020

Mar 13, 2020 EMA Healthcare Agency

PRAC starts review of certain ifosfamide cancer medicines At its monthly meeting, EMA’s safety committee (PRAC) has started a review…

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  • AI is ubiquitous in most areas nowadays but what good can it do for medicine and the healthcare industry?
  • Atripla
  • New medicine for hereditary rare disease
  • PRAC confirms four-week limit for use of high-strength estradiol creams
  • Omega-3 fatty acid medicines no longer considered effective in preventing heart disease
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  • Maximum residue limits (MRL)
  • Scientific advice on MRL classification of chemical-unlike biological substances considered as not requiring an MRL evaluation according to Regulation (EU) 2018/782
  • Business hours and holidays
  • Human medicines European public assessment report (EPAR): Capvaxive, pneumococcal polysaccharide conjugate vaccine (21-valent), Date of authorisation: 24/03/2025, Revision: 3, Status: Authorised
  • PRAC: Working parties and other groups of interest

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RSS News and press releases
  • EMA Management Board: highlights of October 2025 meeting
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 September - 2 October 2025
  • Advice on end-of-year submission dates for type I variations in 2025
  • A path to better include patients’ perspectives in the regulation of medicines
  • New co-chairs elected for working parties for healthcare professionals and for patients and consumers
RSS New medicines: Human
  • Human medicines European public assessment report (EPAR): Vivlipeg, pegfilgrastim, Date of authorisation: 18/08/2025, Status: Authorised
  • Human medicines European public assessment report (EPAR): Enflonsia, clesrovimab, Status: Opinion
  • Human medicines European public assessment report (EPAR): Imaavy, nipocalimab, Status: Opinion
  • Human medicines European public assessment report (EPAR): Zvogra, denosumab, Status: Opinion
  • Human medicines European public assessment report (EPAR): Xbonzy, denosumab, Status: Opinion
RSS Regulatory and Procedural Guidelines
  • Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements
  • List of centrally authorised products with safety-related changes to the product information
  • Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025
  • Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) dataload friendly file including deprecated terms
  • Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin

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