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Gardasil, vaccine against HPV (Human Papillomaviruses), is available again

After a period of limited availability, the Gardasil 9 vaccine, used to prevent Human Papillomaviruses (HPV), is available to everyone again.

PRAC September 2020 – Revocation of marketing authorisation of ulipristal acetate (Esmya) for uterine fibroids

During its meeting of September 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended the revocation of marketing authorisation of ulipristal acetate for uterine fibroids.

Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.

Nitrosamines in medicinal products: deadlines for submitting risk assessments, the results of confirmatory tests and the MA adaptation

Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked all marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The result of this risk assessments must be reported via the particular web form, before 31 March 2021 for chemical medicinal products and before 1 July 2021 for biological medicinal products. MA (marketing authorisation) variations must be submitted before 26 September 2022 (chemical medicinal products) and before 1 July 2023 (biological medicinal products).

Influenza vaccination 2020-2021: sequential approach with priority for at-risk groups

COVID-19 makes it important to be able to vaccinate at-risk groups to the maximum extent possible in order to avoid overburdening the healthcare sector. Therefore, influenza vaccination for 2020-2021 will be phased in, giving priority to those at risk.

Coronavirus – Evaluation of the use of saliva samples as an alternative to sampling via a deep nasal swab to detect SARS-CoV-2, the virus that causes COVID-19

Because of the benefits to both patients and healthcare professionals, a study on the use of saliva samples as an alternative to sampling via a deep nasal swab (nasopharyngeal) to detect SARS-CoV-2 using molecular detection tests (PCR) was launched on 28 May 2020.

Coronavirus - Derogation for COVID-19 clinical trials of medicinal products containing or consisting of genetically modified organisms

In the context of the COVID-19 crisis, the European Union adopted a regulation providing for a temporary derogation from European legislation on genetically modified organisms.

Nitrosamines in medicinal products: templates and web forms for submitting the results of confirmatory tests

Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked all marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The result of this risk assessments (step 1) must be reported via the particular web form before 1 October 2020. Another particular web form is available for submitting the results of the confirmatory tests (step 2).

Flash VIG-news: avoid errors in dosing oral liquid forms by using the dosing device supplied with the medicine

Dosing devices for liquid medicines are generally not interchangeable. To avoid dosing errors, the FAMHP recalls the importance of using the dosing device supplied with the medicine.

Coronavirus: further extension of the measures taken by the FAMHP to avoid medicinal product shortages

On 1 April 2020, the FAMHP took steps regarding a range of medicinal products in order to avoid any shortage. These measures have now been extended by one month.

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