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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa
Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020 -
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization
Active substance: andexanet alfa, DHPC type: Adverse event, Last updated: 04/11/2020 -
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Direct healthcare professional communication (DHPC): Dexmedetomidine: Increased risk of mortality in intensive care unit (ICU) patients ≤65 years
Active substance: dexmedetomidine hydrochloride, DHPC type: Safety signal, Last updated: 16/06/2022 -
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Direct healthcare professional communication (DHPC): Picato (ingenol mebutate): Suspension of the marketing authorisation due to risk of skin malignancy
Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020 -
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Direct healthcare professional communication (DHPC): Strimvelis® (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase [ADA] cDNA sequence): first case of lymphoid T cell leukaemia after insertional oncogenesis
Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, DHPC type: Adverse event, Last updated: 22/03/2021 -
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Direct healthcare professional communication (DHPC): Visudyne (verteporfin): Information on the continuing supply restriction until end Q1/2022
Active substance: verteporfin, DHPC type: Medicine shortage, Last updated: 05/11/2021 -
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Direct healthcare professional communication (DHPC): Visudyne (verteporfin): Information on the continuing supply limitation until end of 2023
Active substance: verteporfin, DHPC type: Medicine shortage, Last updated: 12/08/2022 -
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Direct healthcare professional communication (DHPC): GLOBAL RECALL: Zerbaxa (ceftolozane / tazobactam) 1 g/0.5 g powder for concentrate for solution for infusion
Active substance: Ceftolozane, tazobactam, DHPC type: Quality defect, Last updated: 22/12/2020 -
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Direct healthcare professional communication (DHPC): Tepadina (thiotepa) 100 mg: possible risk of defective vials in batches n°1709192/1, n°1709192/2 and n°1709192/3 presenting a crimp seal not properly fixed on the vial
Active substance: thiotepa, DHPC type: Quality defect, Last updated: 02/06/2020 -
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Direct healthcare professional communication (DHPC): Important information on Gliolan (5-aminolevulinic acid, 5-ALA): What to do in case of delayed surgery and information on fluorescence in non high-grade glioma
Active substance: 5-aminolevulinic acid hydrochloride, DHPC type: Type II variation, Last updated: 01/12/2020 -
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Direct healthcare professional communication (DHPC): Xeljanz (tofacitinib): Initial clinical trial results of increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF— alpha inhibitors
Active substance: tofacitinib citrate, DHPC type: Safety signal, Last updated: 24/03/2021 -
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Direct healthcare professional communication (DHPC): Xeljanz (tofacitinib): increased risk of major adverse cardiovascular events and malignancies with use of tofacitinib relative to TNF-alpha inhibitors
Active substance: tofacitinib citrate, DHPC type: Safety signal, Last updated: 06/07/2021 -
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Direct healthcare professional communication (DHPC): Shortage of Nucala (mepolizumab) Pre-Filled Pen (EU/1/15/1043/003, EU/1/15/1043/004)
Active substance: Mepolizumab, DHPC type: Medicine shortage, Last updated: 27/01/2021 -
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Direct healthcare professional communication (DHPC): Mavenclad (cladribine) – risk of serious liver injury and new recommendations about liver function monitoring
Active substance: Cladribine, DHPC type: Adverse event, Last updated: 14/02/2022 -
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Direct healthcare professional communication (DHPC): RoActemra (tocilizumab): Temporary supply shortage for 162 mg solution for subcutaneous injection and RoActemra 20 mg/mL concentrate for solution for infusion (IV) & recommendations to manage potential risk of disease flare in patient
Active substance: tocilizumab, DHPC type: Medicine shortage, Last updated: 02/09/2021 -
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet
Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020 -
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Direct healthcare professional communication (DHPC): Nomegestrol and chlormadinone containing medicines: Measures to minimise the risk of meningioma
Active substance: nomegestrol, chlormadinone, DHPC type: Adverse event, Referral - Article 31, Last updated: 08/11/2022 -
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Direct healthcare professional communication (DHPC): Xagrid (anagrelide hydrochloride): Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation
Active substance: Anagrelide, DHPC type: Safety signal, Last updated: 22/02/2022 -
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Direct healthcare professional communication (DHPC): Briviact® (In Italy: Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck diameter
Active substance: Brivaracetam, DHPC type: Quality defect, Last updated: 20/12/2021 -
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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): 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): Ozempic (semaglutide) solution for injection in pre-filled pen: supply shortage
Active substance: semaglutide, DHPC type: Medicine shortage, Last updated: 19/10/2022 -
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Direct healthcare professional communication (DHPC): Imbruvica (ibrutinib): New risk minimisation measures, including dose modification recommendations, due to the increased risk for serious cardiac events
Active substance: Ibrutinib, DHPC type: Post-authorisation measure, Last updated: 03/11/2022 -
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Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
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Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter
Active substance: Letermovir, Last updated: 11/09/2020