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102 results
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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): 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): 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): 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): Suboxone sublingual tablets (buprenorphine / naloxone): inaccurate Braille information on the carton for HU/CZ/SK pack
Active substance: buprenorphine, naloxone, DHPC type: Quality defect, Last updated: 18/06/2020 -
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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): Insuman Implantable 400 IU/ml insulin solution for infusion: no new patients should be started due to discontinuation of MiniMed Implantable Pump
Active substance: insulin human, DHPC type: Type II variation, Last updated: 21/07/2020 -
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Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Batch-specific product recall
Active substance: alpha1-proteinase inhibitor (human), DHPC type: Quality defect, Last updated: 12/02/2021 -
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Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Sterility issue with the infusion device co-packed with Respreeza 4.000 mg and 5.000 mg
Active substance: Human alpha1-proteinase inhibitor, DHPC type: Medicine shortage, Last updated: 26/03/2021 -
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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: 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): 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): 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): 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): Nulojix (belatacept): Risk of medication errors due to change in maintenance dose from 5 mg/kg to 6 mg/kg
Active substance: belatacept, DHPC type: Medication error, Last updated: 12/09/2022 -
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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): 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): 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): 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): 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): 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): 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