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PRAC July 2022 – New measures for medicinal products containing nomegestrol or chlormadinone and start of assessment of neurodevelopmental disorders when using topiramate

During its July 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone. The PRAC also starts the review on the risk of neurodevelopmental disorders with topiramate.

The online medicinal products database gets an update

The FAMHP online medicinal products database contains information on all medicinal products for human and veterinary use authorised in Belgium. Some new functions have been added in this new version. This makes it easier to search for new medicinal products or active ingredients.

Antibiotics: amoxicillin for injection/infusion again available under the trade name Delamoxyle

The availability of appropriate antimicrobial medicines is important to fight antimicrobial resistance. The FAMHP strives to keep or to bring essential antimicrobial products on the market and to keep healthcare professionals and patients well informed. Again, as a result of those efforts: amoxicillin for injection/infusion has been back on the market in Belgium since April.

The FAMHP launches the Medicinal Product Management database: updating data in existing medicinal product databases temporarily not possible

On 4th of July 2022, the FAMHP launches the Medicinal Product Management database, a new internal database for medicinal products. Due to the launch, it will be temporarily impossible to update the data in the existing medicinal product databases.

PRAC May 2022 – Discussion regarding a direct healthcare professional communication (DHPC) containing important information for Defitelio

During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) discussed a direct healthcare professional communication (DHPC) containing important information for Defitelio.

Impact of war in Ukraine on clinical trials

The current war in Ukraine has had a huge impact on clinical trials in Ukraine, Russia and Belarus. Due to the war, a large number of patients in these countries participating in clinical trials are no longer able to participate. There are also problems with the supply of medicinal products and other supplies for conducting clinical trials. The relevant authorities in countries within the European Union are making every effort to ensure the continuity of treatment for patients in ongoing clinical trials by providing the option to continue their treatment at trial sites abroad.

PRAC April 2022 – No causal association found between the COVID-19 vaccines Comirnaty and Spikevax and autoimmune hepatitis

During its April 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded that available evidence does not support a causal link between COVID-19 vaccines Comirnaty and Spikevax and very rare cases of autoimmune hepatitis.

Genotoxic medicines and contraception: recommendations for all genotoxic active substances, regardless of therapeutic indication

The European Medicines Agency's Safety Working Party clarifies its recommendations on genotoxic medicines and the duration of contraception to apply to any genotoxic active substance, regardless of its therapeutic indication. However, the recommendations should not apply to active substances whose mechanism of genotoxicity is known to have a threshold which is not expected to be reached in patients. Marketing authorisation holders should take these new clarifications into account when considering the need to update their package leaflets.

Iodine tablets : recommendations for citizens and pharmacists

Over the past few weeks, more than three hundred thousand citizens have obtained iodine tablets from their pharmacies as a result of the conflict in Ukraine. The FAMHP has listed a few recommendations.

The FAMHP encourages non-profit organisations and academia to apply for the pilot project for the repurposing of authorised medicines

The FAMHP takes part in the European pilot project for the repurposing of medicines to support non-profit organisations and academia. The project was launched by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).

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