News FAMHP

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Warning against the use of illegal TKTX ointment after applying tattoos

The FAMHP wants to warn consumers in Belgium not to use TKTX ointment, an illegal pain-relieving cream. It is mainly used to alleviate pain when applying a tattoo, permanent make-up ... TKTX ointment is not licensed in Belgium or Europe and therefore no guarantees can be given with regard to the composition, safety, quality or efficiency of this illegal medicine.

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.

Be careful of your pets when you use hormonal medicinal products on the skin.

In many European countries, side effects have been reported in pets whose owners use transdermal oestrogen-containing medicinal products. The pets came into contact with or licked the area where the medicinal product was applied, usually the upper arm.

Give your opinion on a genetically modified medicine for the treatment of Duchenne muscular dystrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SRP-9001 for the treatment of Duchenne muscular dystrophy. The public consultation runs from 17 January 2022 to 16 February 2022.

Warning against online sales of counterfeit medicine Seresto®, an anti-flea and anti-tick collar for cats and dogs

A counterfeit version of the medicine Seresto® collar for cats and dogs is being sold through Dutch online stores. The FAMHP warns against pet health hazards.

Limited availability of RoActemra (Roche): recommendations for (hospital) pharmacists, general practitioners and physician specialists.

The stock of RoActemra, a medicinal product used for certain rheumatological and haematological disorders, is currently limited worldwide. The Federal Agency for Medicines and Health Products (FAMHP) therefore issues recommendations.

PRAC June 2021 – EMA advises on Vaxzevria (COVID-19 Vaccine AstraZeneca) and update on ongoing evaluation of COVID-19 vaccines

During its June 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) advises against use of Vaxzevria in people with history of capillary leak syndrome. The PRAC is also continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines.

Killapods is considered to be a medicinal product

Based on the risk to the consumer, the Joint Commission’s Chamber for products for human considers Killapods nicotine pouches medicinal product by function.

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).

Coronavirus and the fight led by the FAMHP: the FAMHP carries out hundreds of controls and inspections to ensure the compliance and safety of medicines and health products

Since the start of the coronavirus pandemic, the FAMHP teams have been working relentlessly and have devoted a lot of resources to monitoring medical devices delivered to Belgium and imported medicinal products.

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