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24 results
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Summary of opinion: Vegzelma
bevacizumab, opinion date: 23/06/2022, Positive, Last updated: 21/06/2022 -
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Summary of opinion: Kauliv
teriparatide, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
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Summary of opinion: Enhertu
trastuzumab deruxtecan, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
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Summary of opinion: Libtayo
cemiplimab, opinion date: 13/10/2022, Positive, Last updated: 14/10/2022 -
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Summary of opinion: Dimethyl fumarate Accord
dimethyl fumarate, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Enhertu
trastuzumab deruxtecan, opinion date: 15/12/2022, Positive, Last updated: 14/12/2022 -
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Summary of opinion: Hemgenix
etranacogene dezaparvovec, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Dapagliflozin Viatris (new)
dapagliflozin, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Tolvaptan Accord (new)
tolvaptan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun (new)
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone): Discontinuation of manufacturing at the end of 2024 and update on 100mcg shortage
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 04/10/2022 -
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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): 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): 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): 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): 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): 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): 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 -
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Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone) 100 micrograms/dose powder and solvent for solution for injection: expected shortage from June 30th, 2022
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 29/04/2022 -
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020 -
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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 (new)
Active substance: paclitaxel, DHPC type: Medicine shortage, Last updated: 25/01/2023 -
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Direct healthcare professional communication (DHPC): Infliximab (Remicade, Flixabi, Inflectra, Remsima and Zessly): Use of live vaccines in infants exposed in utero or during breastfeeding
Active substance: infliximab, DHPC type: New contraindication, Last updated: 07/03/2022