Urgent Drug Warning: Outdated Patient Leaflet for Olmesartan Medoxomil Tablets
Jubilant Pharmaceuticals NV has reported a packaging error involving certain batches of Olmesartan medoxomil 10mg film-coated tablets. According to the…
Europe
europe updates on medical device regulation and quality.
258 articles
258 articles in Europe
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July 2025 MHRA Safety Update: Essential Guidance for Medicines and Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has released its latest safety guidance aimed at users of medicines and…
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Fucidin 250 mg Tablets Recall Announced Due to Impurity Concerns
On September 30, 2025, LEO Pharma issued a recall notice for one batch of Fucidin 250 mg Tablets following routine…
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Critical Updates: Field Safety Notices for Medical Devices (28 July – 1 August 2025)
Between 28 July and 1 August 2025, healthcare teams were informed of updates to multiple Field Safety Notices (FSNs) related…
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Medical Alert: Label and Packaging Error Identified for Topiramate Zydus 20mg/ml Oral Solution
Zydus Pharmaceuticals UK Ltd has released a critical notification regarding an error on the packaging and patient information leaflet (PIL)…
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Critical Updates: Field Safety Notices Issued From 4 to 8 August 2025
Clinical, quality, and regulatory teams should note the latest field safety notices issued between 4 and 8 August 2025. These…
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Urgent Update: Safety Information Missing in Levetiracetam Accord Oral Solution Documents
Accord Healthcare Limited, UK has formally notified the Medicines and Healthcare products Regulatory Agency (MHRA) of a critical defect related…
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Critical Updates: Field Safety Notices Issued for Medical Devices (11–15 August 2025)
Healthcare professionals, regulatory experts, and clinical teams take note: field safety notices (FSNs) issued between 11 and 15 August 2025…
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IMDRF Unveils Affiliate Membership Opportunity for Global Regulatory Authorities
The International Medical Device Regulators Forum (IMDRF) has introduced an important update for medical device regulatory authorities worldwide. The announcement…
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Important Notification: Barcode Error on Fexofenadine Hydrochloride 120mg Tablets by Chanelle Medical
The Medicines and Healthcare products Regulatory Agency (MHRA) has been notified about a barcode error affecting specific batches of Fexofenadine…
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Regulatory Updates from the 23rd IMDRF Management Committee Meeting in Brussels
The 23rd Management Committee Meeting of the International Medical Device Regulators Forum (IMDRF) took place in Brussels, Belgium, from March…
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Critical Updates: Field Safety Notices for Medical Devices Issued from 5 to 9 May 2025
Medical device users and healthcare teams should note the publication of new Field Safety Notices (FSNs) from 5 to 9…
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