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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Give your opinion on a genetically modified drug for the treatment of Duchenne muscular dystrophy
The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified drug PF-06939926 for the treatment of Duchenne muscular dystrophy. The public consultation will run from 23 September 2020 to 23 October 2020.
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.
The COVID-19 serological tests bought by the government are reliable
Recent articles in the media have once again questioned the reliability of the serological tests bought by the government, in particular the DiaSorin test. The FAMHP is clear: on the basis of current scientific knowledge, this test meets all requirements and can be used without any problems.
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.