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ArjoHuntleigh Tenor Mobile Hoist Safety Alert
The French National Agency for the Safety of Medicines and Health Products (ANSM) has announced a product recall for the ArjoHuntleigh Tenor mobile hoist. This action, registered under number R2606757, is being implemented by the manufacturer ArjoHuntleigh AB.
ANSM Safety Alert for Manosplint Cushionfoam Medical Device
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Manosplint Cushionfoam medical device, identified by safety action number R2606620. This alert concerns a safety action initiated by the manufacturer, Kinetec SAS.
Spinal Plug Safety Alert for Pharmacies
The French ANSM has been informed of a lot recall action for spinal plugs (Airplug T10-T12) by Groupe Lépine, registered under action number R2607057. Pharmacies are directed to consult the provided letter from the manufacturer for details.
Safety alert for DermaGenius 3.0 reagent
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the DermaGenius 3.0 Complete Multiplex real-time PCR reagent. This alert, registered under number R2607183, informs medical biology analysis laboratories of a security action implemented by PathoNostics.
ANSM Safety Information: Mobile Hoist and Bath Elevator
The French National Agency for Medicines and Health Products Safety (ANSM) has issued safety information regarding a mobile hoist and bath elevator from Mangar International. This notice, registered under number R2607055, alerts home healthcare providers and retailers to a safety action implemented by the manufacturer.
ANSM Recalls Risks of Varicose Vein Sclerosing Agents
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a notice recalling the serious cardiovascular risks associated with varicose vein sclerosing agents. The agency emphasizes adherence to recommendations and provides new tutorials for reporting adverse events.
ANSM Warns of Significant Risks from Off-Label Isotretinoin Use
The French National Agency for Medicines and Health Products Safety (ANSM) has issued a warning regarding the off-label promotion and use of isotretinoin-based medications for aesthetic purposes on social media. The agency emphasizes that these drugs are strictly indicated for severe acne and carry significant risks, including psychiatric disorders and birth defects.
ANSM Ensures Continuity of Emend 125 mg Oral Suspension for Children
The ANSM has announced measures to ensure the continuity of treatment for children using Emend 125 mg oral suspension due to supply difficulties. Prescribers are advised to reserve the oral suspension for specific pediatric cases and explore alternative formulations for older children and adults. Importations are being arranged to cover demand.
PRAC Recommends EU Market Withdrawal of Levamisole Medicines
The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of marketing authorizations for medicines containing levamisole from the EU market. This decision is based on a re-evaluation of safety data, concluding that the risks associated with these drugs outweigh their benefits for treating parasitic worm infections.
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