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3023 results
Keyword cancer Remove keyword
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Direct healthcare professional communication (DHPC): Lymphoseek (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life (new)
Active substance: tilmanocept, DHPC type: Medicine shortage, Last updated: 31/01/2023adult patients with breast cancer, melanoma, or localised squamous … -
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Withdrawn application: Imbruvica (new)
ibrutinib, date of withdrawal: 13/12/2022, Post-authorisation, Last updated: 27/01/2023mantle cell lymphoma (MCL, a cancer of a type of white blood … used to treat certain blood cancers involving B cells: MCL in … on its own or with other cancer medicines (bendamustine and … -
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Summary of opinion: Nubeqa (new)
darolutamide, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023hormone- sensitive prostate cancer (mHSPC). For information … castration resistant prostate cancer (nmCRPC) who are at high … hormone-sensitive prostate cancer (mHSPC) in combination with … -
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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 (new)
Active substance: paclitaxel, DHPC type: Medicine shortage, Last updated: 25/01/2023treatment of metastatic breast cancer in adult patients who have … treatment of non-small cell lung cancer in adult patients who are … treatment of metastatic breast cancer in adult patients who have … -
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Orphan designation: 2,4,6,7,8,9-hexahydro-4-((2-methylphenyl)methyl)-7-(phenylmethyl)imidazo(1,2-a)pyrido(3,4-e)pyrimidin-5(1H)-one for: Treatment of glioma (new)
Date of designation: 18/07/2022, Positive, Last updated: 25/01/2023patients with glioma by killing cancer cells and disrupting tumour … -
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Orphan designation: Humanised IgG4 monoclonal antibody against active complement component 1, subcomponent s for: Treatment of autoimmune haemolytic anaemia (new)
Date of designation: 18/07/2022, Positive, Last updated: 25/01/2023 -
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Orphan designation: zilucoplan for: Treatment of myasthenia gravis (new)
Date of designation: 18/07/2022, Positive, Last updated: 25/01/2023 -
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Orphan designation: Odronextamab for: Treatment of follicular lymphoma (new)
Date of designation: 18/07/2022, Positive, Last updated: 25/01/2023immune system) including the cancer cells. It also attaches to … kill the CD20-expressing cancer cells, thereby eliminating … -
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Orphan designation: Odronextamab for: Treatment of diffuse large B-cell lymphoma (new)
Date of designation: 18/07/2022, Positive, Last updated: 25/01/2023immune system) including the cancer cells. It also attaches to … kill the CD20-expressing cancer cells, thereby eliminating … -
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Orphan designation: Adeno-associated viral vector serotype 9 containing the human ABCD1 gene for: Treatment of adrenoleukodystrophy (new)
Date of designation: 11/11/2022, Positive, Last updated: 25/01/2023 -
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Orphan designation: Autologous naive regulatory T cells transduced with a lentiviral vector encoding for a chimeric antigen receptor to recognise the HLA-A*02 antigen for: Treatment in solid organ transplantation (new)
Date of designation: 18/07/2022, Positive, Last updated: 25/01/2023 -
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Orphan designation: Crofelemer for: Treatment of microvillus inclusion disease (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023 -
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Orphan designation: Autologous T cells transduced with a lentiviral vector expressing a chimeric antigen receptor against CLL-1 for: Treatment of acute myeloid leukaemia (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023binds to CLL-1-expressing cancer cells. Studies demonstrated … -
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Orphan designation: Velusetrag for: Treatment of intestinal pseudo-obstruction (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023 -
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Orphan designation: Inaxaplin for: Treatment of apolipoprotein L1-mediated kidney disease (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023 -
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Orphan designation: Adeno‐associated viral vector serotype 8 containing the 3' human otoferlin coding sequence, adeno‐associated viral vector serotype 8 containing the 5' human otoferlin coding sequence for: Treatment of otoferlin gene-mediated hearing loss (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023 -
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Orphan designation: Aglatimagene besadenovec for: Treatment of glioma (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023tumour, it instructs the cancer cells to make thymidine kinase … a medicine that kills the cancer cells. Additionally, the … the body, to also fight the cancer cells … -
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Orphan designation: Eculizumab for: Treatment of Guillain-Barré syndrome (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023 -
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Orphan designation: Adeno-associated viral vector serotype rh.10 encoding the CLN2 gene for: Treatment of neuronal ceroid lipofuscinosis (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023 -
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Orphan designation: isotretinoin for: Treatment of autosomal recessive congenital ichthyosis (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023 -
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Orphan designation: Human IgG4k monoclonal antibody against CD89 for: Treatment of linear IgA bullous dermatosis (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023 -
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Orphan designation: Etidronate disodium for: Treatment of pseudoxanthoma elasticum (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023 -
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Orphan designation: Sodium ({(2S)-1,4-bis[2-(4-chloro-3-fluorophenoxy)acetamido]bicyclo[2.2.2]octan-2-yl}oxy)methyl hydrogen phosphate-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1/1) for: Treatment of vanishing white matter disease (new)
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023