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33 results
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8 mg vial: shortage and mitigation plan
Active substance: Metreleptin, DHPC type: Medicine shortage, Last updated: 14/03/2023 -
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Direct healthcare professional communication (DHPC): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy
Active substance: Onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021 -
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Direct healthcare professional communication (DHPC): ZOLGENSMA (onasemnogene abeparvovec) - Fatal cases of acute liver failure
Active substance: Onasemnogene abeparvovec, DHPC type: Adverse event, Last updated: 17/02/2023 -
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Direct healthcare professional communication (DHPC): Defitelio (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT)
Active substance: defibrotide, DHPC type: Lack of effect, Safety signal, Last updated: 13/06/2022 -
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Direct healthcare professional communication (DHPC): Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy
Active substance: Lomitapide, DHPC type: Post-authorisation measure, Last updated: 17/02/2021 -
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Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin) 140 mg powder for concentrate for solution for injection: Important information on plastic vial flip-off cap colour
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020 -
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Direct healthcare professional communication (DHPC): Pazenir® (paclitaxel formulated as albumin bound nanoparticles) 5 mg/ml powder for dispersion for infusion: temporary supply shortage
Active substance: paclitaxel, DHPC type: Medicine shortage, Last updated: 25/01/2023 -
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Direct healthcare professional communication (DHPC): Ocaliva (obeticholic acid): New contraindication for the treatment of primary biliary cholangitis (PBC) in patients with decompensated liver cirrhosis or a history of prior hepatic decompensation
Active substance: Obeticholic acid, DHPC type: New contraindication, Last updated: 09/06/2022