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39 results
Medicine type
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Summary of opinion: Vildagliptin / Metformin hydrochloride Accord
vildagliptin / metformin hydrochloride, opinion date: 27/01/2022, Positive, Last updated: 28/01/2022 -
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Summary of opinion: Dimethyl fumarate Polpharma
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Amversio
betaine anhydrous, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Sitagliptin Accord
sitagliptin, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Dimethyl fumarate Neuraxpharm
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Dimethyl fumarate Mylan
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Cabometyx
cabozantinib, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
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Summary of opinion: Amifampridine SERB
amifampridine, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
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Summary of opinion: Pirfenidone AET (new)
pirfenidone, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Ertapenem SUN (new)
ertapenem, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Sugammadex Fresenius Kabi (new)
sugammadex, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Accord (new)
sitagliptin, metformin hydrochloride, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Ganirelix Gedeon Richter (new)
ganirelix, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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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): 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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Orphan designation: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide (ivacaftor) for: Treatment of cystic fibrosis
Date of designation: 08/07/2008, Positive, Last updated: 25/01/2022 -
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Orphan designation: velaglucerase alfa for: Treatment of Gaucher disease
Date of designation: 06/06/2010, Positive, Last updated: 24/09/2021 -
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Orphan designation: Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein (lanadelumab) for: Treatment of hereditary angioedema
Date of designation: 09/10/2015, Positive, Last updated: 20/09/2021 -
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Orphan designation: Chimeric anti-interleukin-6 monoclonal antibody (siltuximab) for: Treatment of Castleman's disease
Date of designation: 30/11/2007, Positive, Last updated: 26/08/2021 -
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Orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid for: Treatment of progressive familial intrahepatic cholestasis
Date of designation: 17/07/2012, Positive, Last updated: 28/07/2021 -
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Orphan designation: Risdiplam for: Treatment of spinal muscular atrophy
Date of designation: 26/02/2019, Positive, Last updated: 04/05/2021 -
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Orphan designation: Ketoconazole for: Treatment of Cushing's syndrome
Date of designation: 23/04/2012, Positive, Last updated: 22/09/2020 -
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Orphan designation: Eculizumab for: Treatment myasthenia gravis
Date of designation: 29/07/2014, Positive, Last updated: 20/11/2019 -
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Orphan designation: Recombinant human lysosomal acid lipase for: Treatment of lysosomal acid lipase deficiency
Date of designation: 17/12/2010, Positive, Last updated: 20/11/2019 -
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Orphan designation: Eculizumab for: Treatment of neuromyelitis optica spectrum disorders
Date of designation: 05/08/2013, Positive, Last updated: 20/11/2019