29.07.2024
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Mysimba (naltrexone/bupropion): EMA advises about risks of using weight loss medicine Mysimba with opioids
Active substance: naltrexon, bupropion
The European Medicines Agency (EMA) draws attention to the risks of using the weight loss medication Mysimba in combination with opioids.
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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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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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16.08.2023
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Valproate: Evaluation of data on paternal exposure by the PRAC
Active substance: Valproat
The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is currently evaluating data on the potential risk of neurodevelopmental disorders in children born to men taking valproate-containing medicines.
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30.03.2023
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Methotrexate-containing medicinal products: improving risk awareness by changing risk-minimising measures - results of a study commissioned by the EMA
Active substance: methotrexate
The study commissioned by the EMA to review the effectiveness of mandated measures to minimise medication errors in therapy with methotrexate-containing medicinal products has been completed. The study results and possible resulting safety measures will be described and discussed in detail in the next PSUSA procedure for methotrexatehaleradministered by the BfArM.
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12.07.2022
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Azido impurity in losartan
Active substance: losartan
Azido impurity in losartan
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27.11.2020
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Hydroxychloroquine and Chloroquine: psychiatric disorders
Active substance: hydroxychloroquine, chloroquine
Current information about psychiatric disorders for Chloroquine and Hydroxychloroquine.
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16.10.2020
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EU regulators request nitrosamine testing of metformin medicines (CHMP meeting highlights 12-15 October 2020)
Active substance: metformin
EU regulators request nitrosamine testing of metformin medicines
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06.10.2020
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Remdesivir (Veklury®): PRAC checks signal for kidney damage
Active substance: remdesivir
PRAC has begun reviewing a safety signal for acute renal damage in some COVID-19 patients treated with Veklury® (Remdesivir).
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02.06.2020
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Hydroxychloroquine: renewed warning of risks when used to treat COVID-19
Active substance: hydroxychloroquine, chloroquine
The European Medicines Agency (EMA) again warns about the risks of using hydroxychloroquine (and chloroquine) to treat COVID-19.
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15.05.2020
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Hormone replacement therapy: PRAC completes review of new information on known breast cancer risk
Active substance: substances for hormone replacement therapy
The Committee for Pharmacovigilance Risk Assessment (PRAC) of the EMA recommends updating the current safety information of medicinal products for HRT, in relation to the known increased risk of breast cancer.
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29.04.2020
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Hydroxychloroquine: risk of serious side effects when used to treat COVID-19
Active substance: hydroxychloroquine, chloroquine
The BfArM informs about the risk of serious side effects when using hydroxychloroquine for the treatment of COVID-19.
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01.04.2020
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Increased ring fractures with vaginal rings
Active substance: ethinylestradiol/etonogestrel
The BfArM has received a large number of reports of breaks in the vaginal rings GinoRing® (Exeltis Germany GmbH), Cyclelle® (Hexal AG), VeriAristo® (Aristo Pharma GmbH) and Setlona® (Mylan Germany GmbH), which are used for hormonal contraception. These reports indicate a quality defect.
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26.03.2020
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COVID-19: beware of falsified medicines from unregistered websites
Active substance: diverse
The BfArM and the EMA advise the public not to purchase medicines from unauthorised websites or other vendors trying to take advantage of the fears and concerns of the public.
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17.09.2019
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Ranitidine: Recall of ranitidine containing drugs
Active substance: Ranitidin
The Federal Institute for Drugs and Medical Devices (BfArM) informs that in the European Union there is a recall of drugs containing the active substance ranitidine produced by the active substance manufacturer Saraca Laboratories Limited.
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