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Medicine
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Direct healthcare professional communication (DHPC): CHAMPIX (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the acceptable intake limit
Active substance: varenicline, DHPC type: Medicine shortage, Last updated: 30/09/2021 -
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Direct healthcare professional communication (DHPC): Tecentriq (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)
Active substance: atezolizumab, DHPC type: Adverse event, Last updated: 25/03/2021 -
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Direct healthcare professional communication (DHPC): Brivudine: potentially fatal toxicity of fluoropyrimidines if administered shortly before or at the same time with brivudine or used within 4 weeks after the end of treatment with brivudine
Active substance: Brivudine, DHPC type: Periodic safety update single assessment, Last updated: 12/05/2020 -
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Direct healthcare professional communication (DHPC): Metamizole: Risk of drug-induced liver injury
Active substance: metamizole, DHPC type: Periodic safety update report, Last updated: 15/12/2020 -
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Direct healthcare professional communication (DHPC): Restrictions in use of cyproterone acetate due to risk of meningioma
Active substance: cyproterone, DHPC type: Referral - Article 31, Last updated: 29/04/2020 -
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Direct healthcare professional communication (DHPC): Flucytosine: Updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency
Active substance: Flucytosine, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
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Direct healthcare professional communication (DHPC): Leuprorelin-containing depot products: need to strictly follow instructions for reconstitution and administration to reduce the risk of handling errors that may result in lack of efficacy
Active substance: leuprorelin, DHPC type: Referral - Article 31, Last updated: 02/10/2020 -
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Direct healthcare professional communication (DHPC): Risks associated with systemic exposure to estradiol creams
Active substance: estradiol, DHPC type: Referral - Article 31, Last updated: 20/02/2020 -
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Direct healthcare professional communication (DHPC): Ecalta 100mg powder for concentrate for solution for infusion (anidulafungin) - Solution for infusion must no longer be frozen
Active substance: anidulafungin, DHPC type: Quality defect, Last updated: 14/02/2020 -
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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): 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 -
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Direct healthcare professional communication (DHPC): Risk of acute adrenal insufficiency when switching from crushed or compounded oral hydrocortisone formulations to Alkindi (hydrocortisone granules in capsules for opening)
Active substance: hydrocortisone, DHPC type: Safety signal, Last updated: 04/02/2021 -
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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): Eylea 40 mg/mL (aflibercept solution for intravitreal injection): Higher risk of intraocular pressure increase with the pre-filled syringe
Active substance: aflibercept, DHPC type: Adverse event, Last updated: 15/04/2021 -
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Direct healthcare professional communication (DHPC): Gilenya (fingolimod): Updated recommendations to minimise the risk of drug-induced liver injury (DILI)
Active substance: Fingolimod, DHPC type: Periodic safety update report, Last updated: 10/11/2020 -
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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): 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): 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): 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): 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