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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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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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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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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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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12.01.2024
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Valproate: risk of congenital malformations and developmental problems associated with use during pregnancy
Active substance: valproate
Educational material on medicinal products containing valproate
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12.01.2024
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Valproate: Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines
Active substance: valproate
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends precautionary measures for the treatment of male patients with valproate-containing medicinal products.
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26.01.2024
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Valproate: Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines
Active substance: valproate
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines.
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15.02.2024
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Direct Healthcare Professional Communication (DHPC) on pseudoephedrine: risks of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome
Active substance: pseudoephedrine
Few cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine-containing medicinal products.
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16.02.2024
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Contrast agents containing gadolinium: deposits in the brain and other tissues
Active substance: gadolinium
For contrast agents containing gadolinium, the suspension of marketing authorisations has been extended until 28 February 2026.
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19.02.2024
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Direct Healthcare Professional Communication (DHPC) on valproate-containing medicines: potential risk of neurodevelopmental disorders in children of fathers treated with valproate
Active substance: valproate
The marketing authorisation holders of valproate-containing medicinal products would like to inform you about new measures regarding an increased risk of neurodevelopmental disorders in children born to men treated with valproate.
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23.02.2024
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Direct Healthcare Professional Communication (DHPC) on combined hormonal contraceptives with chlormadinone acetate/ethinyl estradiol: Slightly increased risk of venous thromboembolism
Active substance: chlormadinone acetate, ethinyl estradiol
The marketing authorization holders of combined hormonal contraceptives containing chlormadinone acetate and ethinyl estradiol provide information about a slightly increased risk of venous thromboembolism.
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01.03.2024
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Information Letter on Spiolto Respimat: Possibly defective dose indicator
Active substance: tiotropium bromide/olodaterol hydrochloride
The company Boehringer Ingelheim Pharma GmbH & Co. KG informs about possibly defective dose indicators in two batches of the medicinal product Spiolto Respimat 2.5 micrograms/2.5 micrograms.
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21.03.2024
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Direct Healthcare Professional Communication (DHPC) on Paxlovid (nirmatrelvir, ritonavir): drug interactions with certain immunosuppressants, including tacrolimus
Active substance: nirmatrelvir, ritonavir
Pfizer reminds of already known drug interactions of paxlovid with certain immunosuppressants, including tacrolimus, with potentially life-threatening and fatal consequences.
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25.03.2024
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Start of a review concerning the conduct of studies at Synapse Labs Pvt. Ltd., India
Active substance: various
On 21 March 2024, EMA’s human medicines committee (CHMP) confirmed its recommendation to suspend or not grant the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd., a contract research organisation (CRO) located in Pune, India.
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04.04.2024
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Direct Healthcare Professional Communication (DHPC) on Atropinsulfat 100 mg solution for injection: Risk of visible particles in the solution, use of a filter
Active substance: Atropine sulfate
The company Dr. Franz Köhler Chemie GmbH informs about particle detected during the ongoing stability studies in the medicinal product Atropinsulfat 100 mg solution for injection, 5 x 10 ml and 25 x 10 ml.
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04.04.2024
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Pseudoephedrine: risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
Active substance: pseudoephedrine
With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/EC on medicinal products containing pseudoephedrine has been completed.
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19.04.2024
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Information Letter on Aptivus 250 mg soft capsules: Missing or barely readable capsule imprint
Active substance: tipranavir
The company Boehringer Ingelheim Pharma GmbH & Co. KG informs that batch 308715 of the medicinal product Aptivus 250 mg soft capsules (120 capsules per bottle) may contain capsules with only a faint imprint “TPV 250” or without this imprint at all.
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02.05.2024
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Direct Healthcare Professional Communication (DHPC) on oral retinoids (acitretin, alitretinoin and lsotretinoin): Reminder of existing restrictions to prevent exposure during pregnancy
Active substance: acitretin, alitretinoin, isotretinoin
The marketing authorisation holders of acitretin-, alitretinoin- and isotretinoin-containing medicinal products remind you of the pregnancy prevention program for oral retinoids.
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08.05.2024
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Direct Healthcare Professional Communication (DHPC) on Irenate (sodium perchlorate) drops from Austria: Risk of incorrect dosing due to a different dosage (number of drops per millilitre)
Active substance: sodium perchlorate
Irenate (sodium perchlorate) drops from Austria: Risk of incorrect dosing due to a different dosage a different dosage (number of drops per millilitre).
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