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87 results
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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): Venclyxto - (venetoclax) film coated tablets: Updated recommendations on tumour lysis syndrome (TLS) in CLL patients
Active substance: Venetoclax, DHPC type: Type II variation, Last updated: 10/06/2021 -
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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): 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): 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): 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): 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): 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): 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): 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 -
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Direct healthcare professional communication (DHPC): Tecfidera (dimethyl fumarate): Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia
Active substance: dimethyl fumarate, DHPC type: Type II variation, Last updated: 12/11/2020 -
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Direct healthcare professional communication (DHPC): Rucaparib (Rubraca® ): interim data from Study CO-338-043 (ARIEL4) show a decrease in overall survival compared to standard of care
Active substance: rucaparib camsylate, DHPC type: Referral - Article 20 procedure, Last updated: 06/05/2022 -
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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): 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 -
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Direct healthcare professional communication (DHPC): Lymphoseek® (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life
Active substance: tilmanocept, DHPC type: Medicine shortage, Last updated: 07/12/2021 -
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Direct healthcare professional communication (DHPC): Lymphoseek® (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life
Active substance: tilmanocept, DHPC type: Medicine shortage, Last updated: 30/05/2022 -
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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): 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): Nulojix (belatacept): Extension of the temporary restriction in supply up until 4Q 2021 (initiated in March 2017)
Active substance: belatacept, DHPC type: Medicine shortage, Last updated: 23/09/2020 -
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Direct healthcare professional communication (DHPC): Nulojix (belatacept): Further extension of the temporary restriction in supply up until 3Q 2022
Active substance: belatacept, DHPC type: Medicine shortage, Last updated: 17/01/2022 -
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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): Imlygic (talimogene laherparepvec): Special considerations to minimize the potential occurrence of adverse events in HSV-1 seronegative patients receiving vials from affected lots: Injections from Imlygic 106 PFU/mL vials from the affected lot numbers ...
Active substance: talimogene laherparepvec, DHPC type: Adverse event, Quality defect, Last updated: 16/06/2022 -
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Direct healthcare professional communication (DHPC): Forxiga (dapagliflozin) 5mg should no longer be used for the treatment of Type 1 Diabetes Mellitus
Active substance: dapagliflozin propanediol monohydrate, DHPC type: Type II variation, Last updated: 11/11/2021 -
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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