24.04.2025
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Direct Healthcare Professional Communication on Opzelura 15 mg/g cream: Important information regarding presence of particles in Opzelura cream
Active substance: Ruxolitinib phosphate
The company Incyte Biosciences Distribution B.V. informs about possible particles in Opzelura 15 mg/g cream, which may form during production from the active substance.
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22.04.2025
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Direct Healthcare Professional Communication (DHPC) on Livopan (Nitrous Oxide/Oxygen) 50 %/50 % gas for medical use, compressed: Risk of gas leakage and interruption of gas supply to patients when the flow rate is above 8 l/min
Active substance: Nitrous Oxide, Oxygen
The company Linde Sverige AB informs about a quality defect of the medicinal product Livopan when used with a Fir Tree connector for direct connection with O2/N2O breathing systems.
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31.03.2025
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Mysimba: potential long-term cardiovascular risk
Active substance: naltrexone, bupropion
EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), regarding the potential long-term cardiovascular risk (affecting the heart and blood circulation).
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21.03.2025
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Metamizole-containing medicinal products: risk of agranulocytosis - referral
Active substance: metamizole
With the publication of the European Commission's decision, the risk assessment procedure on the medicinal products containing metamizole has been completed.
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27.02.2025
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Direct Healthcare Professional Communication on Emblaveo 1.5 g/0.5 g powder for concentrate for solution for infusion: risk of cracked or broken vials
Active substance: Aztreonam, Avibactam
The company Pfizer Europe MA EEIG informs about the risk of broken or cracked glass vials of Emblaveo 1.5 g/0.5 g powder for concentrate for solution for infusion.
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17.02.2025
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Information letter on Kisqali 200 mg film tablets: change to storage conditions and shelf life
Active substance: ribociclib
The company Novartis Pharma GmbH informs about a change to storage condtions and shelf life of Kisqali 200 mg film tablets.
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13.01.2025
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Direct Healthcare Professional Communication (DHPC) on Veoza (fezolinetant): risk of drug-induced liver injury and new recommendations on monitoring of liver function before and during treatment
Active substance: fezolinetant
The marketing authorisation holder of Veoza (fezolinetant) would like to inform about the risk of drug-induced liver injury.
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19.12.2024
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Oxbryta (voxelotor): EMA recommends suspension of sickle cell disease medicine Oxbryta
Active substance: voxelotor
The European Commission has decided to suspend the marketing authorization for the medicinal product Oxbryta (voxelotor) for sickle cell disease. This is a precautionary measure during the review of new data.
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09.12.2024
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Direct Healthcare Professional Communication (DHPC) on metamizole-containing medicines: important measures to minimise the serious outcomes of known risk of agranulocytosis
Active substance: metamizole
The marketing authorisation holders of metamizole-containing medicinal products provide information on the early symptoms of agranulocytosis.
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09.12.2024
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Direct Healthcare Professional Communication (DHPC) on Cyanokit 5 g powder for solution for infusion: Potential microbial contamination of certain batches
Active substance: Hydroxycobalamin
The company SERB SA informs about a potential microbial contamination and a possible resulting risk of infection.
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22.11.2024
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Information letter on Airbufo Forspiro 160 µg/4,5 mg and 320 µg/9 mg: possible failure of dose delivery from the first use
Active substance: Budesonide and Formoterole
The company Sandoz GmbH informs about a possible failure of dose delivery in several batches of Airbufo Forspiro.
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