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48 results
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Summary of opinion: Lyumjev (previously Liumjev)
insulin lispro, opinion date: 13/10/2022, Positive, Last updated: 14/10/2022 -
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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: Imfinzi
durvalumab, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
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Summary of opinion: Imfinzi
durvalumab, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Imfinzi
durvalumab, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Xofluza
baloxavir marboxil, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
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Summary of opinion: Wakix
pitolisant, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Fintepla
fenfluramine, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Kerendia
finerenone, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Libtayo
cemiplimab, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Rinvoq
upadacitinib, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
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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: Comirnaty
tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified), opinion date: 19/10/2022, Positive, Last updated: 19/10/2022 -
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Direct healthcare professional communication (DHPC): Ozempic (semaglutide) solution for injection in pre-filled pen: supply shortage update (updated)
Active substance: semaglutide, DHPC type: Medicine shortage, Last updated: 13/03/2023 -
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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): 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): 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): Supply Constraint of Sarilumab [Kevzara®]
Active substance: sarilumab, DHPC type: Medicine shortage, Last updated: 09/11/2021 -
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Direct healthcare professional communication (DHPC): Systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence
Active substance: Delafloxacin, levofloxacin, DHPC type: Safety signal, Last updated: 29/10/2020 -
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Direct healthcare professional communication (DHPC): Rubraca (rucaparib): restriction of indication
Active substance: rucaparib camsylate, DHPC type: Referral - Article 20 procedure, Restriction of indication, Last updated: 08/08/2022 -
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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): Beovu ® (brolucizumab): Updated recommendations to minimise the known risk of intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion
Active substance: Brolucizumab, DHPC type: Type II variation, Last updated: 05/11/2021