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16 results
Medicine
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Summary of opinion: Jemperli
dostarlimab, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Elrexfio
elranatamab, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Ayvakyt (new)
avapritinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Krazati (new)
adagrasib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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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): 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): 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): Caprelsa (vandetanib): Restriction of indication
Active substance: Vandetanib, DHPC type: Restriction of indication, Last updated: 28/02/2023 -
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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): ADAKVEO (crizanlizumab): Phase III study (CSEG101A2301) shows no superiority of crizanlizumab over placebo
Active substance: Crizanlizumab, DHPC type: Referral - Article 20 procedure, Last updated: 14/02/2023 -
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Direct healthcare professional communication (DHPC): ADAKVEO (crizanlizumab): revocation of EU marketing authorisation due to lack of therapeutic efficacy
Active substance: Crizanlizumab, DHPC type: Lack of effect, Referral - Article 20 procedure, Last updated: 15/06/2023 -
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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): Gavreto (pralsetinib): Increased risk for tuberculosis and measures to minimise this risk
Active substance: pralsetinib, DHPC type: Adverse event, Post-authorisation measure, Last updated: 16/06/2023 -
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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