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  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2020, PRAC, 14/02/2020

    PRAC recommends restrictions in use of cyproterone due to meningioma riskFollowing a review of the risk of meningioma (a rare tumour of the membranes...

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  • Restrictions in use of cyproterone due to meningioma risk, PRAC, 14/02/2020

    EMA’s safety committee (PRAC) has recommended that medicines with daily doses of 10 mg or more of cyproterone should only be used for androgen-dependent...

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  • Public access to suspected side effect reports of veterinary medicines, , 12/02/2020

    For the first time, EMA is making suspected side effect reports of veterinary medicines authorised in the European Union publicly accessible through...

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  • EMA to support development of vaccines and treatments for novel coronavirus, , 04/02/2020

    To contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, EMA is taking concrete actions to accelerate the...

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  • EMA to support development of vaccines and treatments for novel coronavirus disease (COVID-19) , , 04/02/2020

    To contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, EMA is taking concrete actions to accelerate the...

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  • EU flags are up in EMA’s new building in Amsterdam, , 03/02/2020

    EMA’s staff gathered today to raise the EU flags in the lobby of its new and final building in Amsterdam.“A year ago, we lowered the flags in our...

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  • UK withdrawal from the EU on 31 January 2020, , 31/01/2020

    The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition...

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  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020, CHMP, 31/01/2020

    Fifteen new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended fifteen medicines for approval at its January 2020...

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  • First treatment for acute hepatic porphyria , CHMP, 31/01/2020

    EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Givlaari (givosiran), the first...

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  • First oral GLP-1 treatment for type 2 diabetes, CHMP, 31/01/2020

    EMA’s human medicines committee (CHMP) has recommended granting a marketing authorization in the European Union (EU) for Rybelsus (semaglutide) for the...

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  • Key principles for the use of electronic product information for EU medicines, , 29/01/2020

    EMA, the Heads of Medicines Agencies (HMA) of EU Member States and the European Commission (EC) have published today key principles outlining a...

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  • Categorisation of antibiotics used in animals promotes responsible use to protect public and animal health, CVMP, 28/01/2020

    Veterinarians are encouraged to check and consider EMA's updated scientific advice on the categorisation of antibiotics when prescribing these medicines...

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  • Martina Schüssler-Lenz re-elected as chair of Committee for Advanced Therapies, , 24/01/2020

    At its January meeting, EMA’s Committee for Advanced Therapies (CAT) re-electedDr Martina Schüssler-Lenz as its chair, for a second three-year mandate.Dr...

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  • Court of Justice upholds EMA’s approach to transparency, , 22/01/2020

    EMA welcomes today’s two appellate judgments by the Court of Justice1 that confirmed, in clear and unambiguous terms, the right of citizens for access to...

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  • Ten recommendations to unlock the potential of big data for public health in the EU, , 20/01/2020

    The joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposes ten priority actions for the European medicines regulatory...

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  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2020, PRAC, 17/01/2020

    EMA suspends Picato as a precaution while review of skin cancer risk continuesAt its January meeting, EMA’s safety committee (PRAC) recommended that...

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  • PRAC confirms four-week limit for use of high-strength estradiol creams, PRAC, 17/01/2020

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

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  • EMA suspends Picato as a precaution while review of skin cancer risk continues, PRAC, 17/01/2020

    EMA is recommending that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its...

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  • EMA welcomes new Head of Information Management Division , , 16/01/2020

    EMA is pleased to announce the appointment of Dr Hilmar Hamann as Head of the Information Management Division as of 16 January 2020.A German national...

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  • Mandatory use of international standard for the reporting of side effects to improve safety of medicines, , 15/01/2020

    At its December 2019 meeting, EMA's Management Board agreed to the mandatory use of a consistent international format, the ISO ICSR format, for reporting...

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