21.12.2023
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Information Letter on Leqvio 284 mg solution for injection in a pre-filled syringe: Important information regarding instructions for use before injection
Active substance: Inclisiran
The company Novartis informs about difficulties in moving the syringe plunger resulting in the inability to inject Leqvio.
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14.12.2023
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Direct Healthcare Professional Communication (DHPC) on miltefosine (Impavido 10 mg/50 mg capsules): Updated warning on ocular changes, including keratitis
Active substance: miltefosine
The company Paesel und Lorei GmbH & Co. KG informs about an updated warning regarding ocular changes.
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14.12.2023
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Direct Healthcare Professional Communication (DHPC) on etoposide (not etoposide phosphate): hypersensitivity reactions with the use of inline filters
Active substance: etoposide
The marketing authorization holders of medicinal products containing etoposide (not etoposide phosphate) inform that there is an increased risk of infusion-related hypersensitivity reactions when using inline filters.
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12.12.2023
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Direct Healthcare Professional Communication (DHPC) on Furosemid-hameln 10 mg/ml (250 mg in 25 ml; 10 x 25 ml ampoules; PZN 16833989): visible particles
Active substance: furosemide
Furosemide-hameln ampoules may contain isolated visible particles. The batches mentioned should be checked visually before use.
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01.12.2023
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Topiramate-containing medicinal products: risks associated with the use of topiramate during pregnancy and in women of childbearing age.
Active substance: Topiramate
In a decision dated 22 November 2023, the Federal Institute for Drugs and Medical Devices (BfArM) implements the unanimous decision of the Coordination Group for Mutual Recognition Procedures and Decentralized Procedures - Human (CMDh) of 11 October 2023 on medicinal products containing topiramate.
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