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109 results
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Direct healthcare professional communication (DHPC): Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) suspension for injection in pre-filled syringe: Important information regarding the potential for breakage of Vaxneuvance pre-filled syringes (updated)
Active substance: Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed), DHPC type: Quality defect, Last updated: 20/09/2023 -
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Direct healthcare professional communication (DHPC): Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab)
Active substance: tocilizumab, Emicizumab, trastuzumab, trastuzumab emtansine, rituximab, pertuzumab, trastuzumab, atezolizumab, DHPC type: Quality defect, Last updated: 17/08/2023 -
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Direct healthcare professional communication (DHPC): Replacement BAXJECT II / BAXJECT II Hi-Flow Reconstitution Devices co-packaged with Advate/Feiba/Rixubis
Active substance: octocog alfa, Factor VIII Inhibitor Bypassing Activity, nonacog gamma, DHPC type: Quality defect, Last updated: 14/08/2023 -
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Direct healthcare professional communication (DHPC): Simponi (golimumab) 50 mg and 100 mg: important changes to the injection instructions for the SmartJect Pre-filled Pen
Active substance: Golimumab, DHPC type: Quality defect, Last updated: 10/08/2023 -
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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): 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): Systemic and inhaled fluoroquinolone antibiotics – reminder on restrictions of use
Active substance: fluoroquinolones, DHPC type: Post-authorisation measure, Last updated: 08/06/2023 -
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Direct healthcare professional communication (DHPC): Arti-Cell® Forte and RenuTend® market recall of select product batches
Active substance: Equine allogeneic mesenchymal stem cells, DHPC type: Quality defect, Last updated: 04/05/2023 -
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Direct healthcare professional communication (DHPC): SIMULECT (basiliximab): Do not use WFI ampoules co-packed with vials of sterile freeze-dried powder of Simulect 10mg and 20mg
Active substance: basiliximab, DHPC type: Quality defect, Last updated: 21/04/2023 -
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Direct healthcare professional communication (DHPC): Menopur (menotropins’ for injection) – quality defect leading to supply shortage
Active substance: menotropin, DHPC type: Medicine shortage, Last updated: 17/04/2023 -
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Direct healthcare professional communication (DHPC): Updated recommendations to minimise the risks of malignancy, major adverse cardiovascular events, serious infections, venous thromboembolism and mortality with use of Janus kinase inhibitors (JAKi)
Active substance: Abrocitinib, filgotinib, Baricitinib, upadacitinib, Tofacitinib, DHPC type: Referral - Article 20 procedure, Last updated: 30/03/2023 -
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Direct healthcare professional communication (DHPC): Pholcodine-containing medicinal products no longer available on the EU market
Active substance: pholcodine, DHPC type: Referral - Article 107i procedure, Last updated: 27/03/2023 -
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8 mg vial: shortage and mitigation plan
Active substance: Metreleptin, DHPC type: Medicine shortage, Last updated: 14/03/2023 -
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Direct healthcare professional communication (DHPC): Ozempic (semaglutide) solution for injection in pre-filled pen: supply shortage update
Active substance: semaglutide, DHPC type: Medicine shortage, Last updated: 13/03/2023 -
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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): Xalkori (crizotinib): Vision disorders, including risk of severe visual loss, need for monitoring in paediatric patients
Active substance: crizotinib, DHPC type: Adverse event, Last updated: 21/02/2023 -
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Direct healthcare professional communication (DHPC): Spikevax bivalent Original/Omicron BA.1, pre-filled syringe - Labelling deviation
Active substance: CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), DHPC type: Adverse event, Last updated: 21/02/2023 -
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Direct healthcare professional communication (DHPC): Terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS)
Active substance: terlipressin, DHPC type: Referral - Article 31, Last updated: 17/02/2023 -
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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): Neofordex 40 mg (dexamethasone): removal of the score-line and the associated 20 mg posology
Active substance: dexamethasone, DHPC type: Change in dosing recommendation, Last updated: 17/02/2023 -
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Direct healthcare professional communication (DHPC): Supply shortage of Fasturtec (rasburicase) 7.5 mg/5 ml powder and solvent for concentrate for solution for infusion (EU/1/00/170/002)
Active substance: rasburicase, DHPC type: Medicine shortage, Last updated: 17/02/2023 -
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Direct healthcare professional communication (DHPC): CYSTAGON (mercaptamine bitartrate)
Active substance: mercaptamine bitartrate, DHPC type: Quality defect, Last updated: 15/02/2023 -
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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): Amfepramone-containing medicines will no longer be available on the EU market, as marketing authorisations will be revoked
Active substance: amfepramone, DHPC type: Referral - Article 31, Last updated: 08/02/2023 -
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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: 31/01/2023