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158 results
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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): Nomegestrol and chlormadinone containing medicines: Measures to minimise the risk of meningioma
Active substance: nomegestrol, chlormadinone, DHPC type: Adverse event, Referral - Article 31, Last updated: 08/11/2022 -
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Direct healthcare professional communication (DHPC): Kaletra (lopinavir/ritonavir) oral solution, 2 bottle pack containing 2-ml oral dosing syringes: Presence of amide particles in 2-ml oral dosing syringes
Active substance: lopinavir, ritonavir, DHPC type: Quality defect, Last updated: 04/01/2021 -
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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): Metalyse (tenecteplase) 8000 units (40 mg) and 10000 units (50 mg) powder and solvent for solution for injection: temporary supply shortage
Active substance: tenecteplase, DHPC type: Medicine shortage, Last updated: 23/09/2022 -
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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): 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 -
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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): Pazenir® (paclitaxel formulated as albumin bound nanoparticles) 5 mg/ml powder for dispersion for infusion: temporary supply shortage
Active substance: paclitaxel, DHPC type: Medicine shortage, Last updated: 25/01/2023 -
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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): 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): 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): 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): 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): 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): Tepadina (thiotepa) 100 mg: possible risk of defective vials in batches n°1709192/1, n°1709192/2 and n°1709192/3 presenting a crimp seal not properly fixed on the vial
Active substance: thiotepa, DHPC type: Quality defect, Last updated: 02/06/2020 -
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Direct healthcare professional communication (DHPC): INOmax (nitric oxide): Difficulties in closing the cylinder valves after use: precautions for use when disconnecting the cylinders from pressure regulators
Active substance: Nitric oxide, DHPC type: Quality defect, Last updated: 03/06/2021 -
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Direct healthcare professional communication (DHPC): Important information on Gliolan (5-aminolevulinic acid, 5-ALA): What to do in case of delayed surgery and information on fluorescence in non high-grade glioma
Active substance: 5-aminolevulinic acid hydrochloride, DHPC type: Type II variation, Last updated: 01/12/2020 -
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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): 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): 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): 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): 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): Dexmedetomidine: Increased risk of mortality in intensive care unit (ICU) patients ≤65 years
Active substance: Dexmedetomidine hydrochloride, DHPC type: Safety signal, Last updated: 16/06/2022