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Medicine
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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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Referral: Synapse (updated)
Article 31 referrals
Status: Procedure started, Last updated: 07/09/2023 -
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Referral: Pseudoephedrine-containing medicinal products (updated)
pseudoephedrine, Article 31 referrals
Status: Under evaluation, Last updated: 05/09/2023 -
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Referral: Topiramate (updated)
topiramate, Article 31 referrals
Status: Recommendation provided by Pharmacovigilance Risk Assessment Committee, Last updated: 01/09/2023 -
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Referral: Adakveo (updated)
crizanlizumab, associated names: Adakveo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/05/2023, EC decision date: 03/08/2023, Last updated: 29/08/2023 -
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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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Referral: Quinolone- and fluoroquinolone-containing medicinal products
nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin, associated names: Quinsair, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 11/03/2019, Last updated: 08/06/2023 -
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Referral: Janus kinase inhibitors (JAKi)
tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/01/2023, EC decision date: 10/03/2023, Last updated: 22/05/2023 -
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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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Referral: Pholcodine-containing medicinal products
pholcodine, Article 107i procedures
Status: European Commission final decision, opinion/position date: 14/12/2022, EC decision date: 06/03/2023, Last updated: 29/03/2023 -
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Referral: Gelisia and associated names
timolol maleate, associated names: Genoptol, Gelisia, Timolol sifi 1 mg/g gel oftalmico, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 27/02/2023, Last updated: 16/03/2023 -
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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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Referral: Rambis and associated names
ramipril, bisoprolol fumarate, associated names: Ralbior, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 15/02/2023, Last updated: 08/03/2023 -
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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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Referral: Amfepramone-containing medicinal products
amfepramone, associated names: Regenon, Tenuate Retard, Amfepramon-Hormosan, Regenon Retard, Article 31 referrals
Status: European Commission final decision, opinion/position date: 10/11/2022, EC decision date: 13/01/2023, Last updated: 20/01/2023 -
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Direct healthcare professional communication (DHPC): Insuman rapid / insuman basal / insuman comb 25 (insulin human): temporary supply shortage and marketing cessation
Active substance: insulin human, DHPC type: Medicine shortage, Last updated: 16/01/2023 -
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Referral: Synchron
Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/05/2022, EC decision date: 28/11/2022, Last updated: 16/12/2022 -
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Referral: Nomegestrol and chlormadinone
nomegestrol, chlormadinone, associated names: Zoely, Article 31 referrals
Status: European Commission final decision, opinion/position date: 01/09/2022, EC decision date: 28/11/2022, Last updated: 14/12/2022 -
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Referral: Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome
terlipressin, Article 31 referrals
Status: CMDh final position, opinion/position date: 10/11/2022, Last updated: 22/11/2022 -
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Referral: Rubraca
rucaparib, associated names: Rubraca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 21/07/2022, EC decision date: 21/09/2022, Last updated: 17/10/2022 -
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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): Direct healthcare professional communication (DHPC): NULOJIX (belatacept): Further extension of the temporary restriction in supply up until 3Q 2023
Active substance: belatacept, DHPC type: Medicine shortage, Last updated: 28/09/2022 -
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Direct healthcare professional communication (DHPC): Cetrorelix acetate - Cetrotide 0.25 mg Powder and solvent for injection: Temporary Shortage
Active substance: cetrorelix (as acetate), DHPC type: Medicine shortage, Last updated: 09/08/2022