132 results
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Orphan designation: Florilglutamic acid (18F) for: Diagnosis of glioma
Date of designation: 21/03/2016, Positive, Last updated: 02/05/2016the European Commission to Piramal Imaging GmbH, Germany, for … the European Commission to Piramal Imaging GmbH, Germany, for … -
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Orphan designation: Florilglutamic acid (18F) for: Diagnosis of hepatocellular carcinoma
Date of designation: 21/03/2016, Positive, Last updated: 02/05/2016the European Commission to Piramal Imaging GmbH, Germany, for … the European Commission to Piramal Imaging GmbH, Germany, for … -
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Human medicine European public assessment report (EPAR): Yargesa
miglustat, Gaucher Disease
Date of authorisation: 22/03/2017,
, Revision: 4, Authorised, Last updated: 02/03/2022
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National expert: Donald Walker, European Medicines Agency (updated)
- Declaration of interests - 82.43 KB | PDF
- Curriculum Vitae - 28.21 KB | PDF
and NASH 02/2013-02/2017 Piramal (via The Research Network … consultancy service provided to Piramal and Kalvista as mentioned … -
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National expert: Emiliano Gemma, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 17.53 KB | PDF
Manufacturing Technician Piramal Healthcare UK Ltd. (United … -
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National expert: Jens Sonksen, European Medicines Agency (updated)
- Declaration of interests - 84.27 KB | PDF
- Curriculum Vitae - 52.99 KB | PDF
cancer 01/2013-02/2014 Orexo alfentanil pain control during prostate … -
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National expert: Stefan Teipel, European Medicines Agency (updated)
- Declaration of interests - 83.72 KB | PDF
- Curriculum Vitae - 18.53 KB | PDF
Disease 01/2017-12/2019 Piramal Imaging Ltd., UK NeuraCeqTM … -
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Human medicine European public assessment report (EPAR): Rezolsta
darunavir, cobicistat, HIV Infections
Date of authorisation: 19/11/2014, Revision: 13, Authorised, Last updated: 14/01/2022 -
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Human medicine European public assessment report (EPAR): Vfend
voriconazole, Candidiasis; Mycoses; Aspergillosis
Date of authorisation: 19/03/2002, Revision: 51, Authorised, Last updated: 06/05/2022 -
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Human medicine European public assessment report (EPAR): Imatinib Teva (updated)
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 18, Authorised, Last updated: 09/06/2022
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Human medicine European public assessment report (EPAR): Voriconazole Accord
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,, Revision: 16, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira)
voriconazole, Bacterial Infections and Mycoses; Aspergillosis; Candidiasis
Date of authorisation: 27/05/2015,, Revision: 11, Authorised, Last updated: 25/04/2022
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Human medicine European public assessment report (EPAR): Imatinib Accord (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 23, Authorised, Last updated: 23/06/2022
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Human medicine European public assessment report (EPAR): Alunbrig
brigatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 22/11/2018,
, Revision: 8, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, 
, Revision: 17, Authorised, Last updated: 22/06/2022
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Human medicine European public assessment report (EPAR): Kisqali (updated)
ribociclib succinate, Breast Neoplasms
Date of authorisation: 22/08/2017, Revision: 9, Authorised, Last updated: 09/06/2022 -
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 4, Authorised, Last updated: 12/04/2022
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , 
, Revision: 6, Authorised, Last updated: 28/04/2022
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Human medicine European public assessment report (EPAR): Xalkori (updated)
crizotinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 23/10/2012, Revision: 32, Authorised, Last updated: 27/06/2022 -
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Human medicine European public assessment report (EPAR): Vitrakvi
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 5, Authorised, Last updated: 09/02/2022
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Human medicine European public assessment report (EPAR): Dexdor
dexmedetomidine hydrochloride, Conscious Sedation
Date of authorisation: 15/09/2011, Revision: 14, Authorised, Last updated: 05/01/2022 -
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Human medicine European public assessment report (EPAR): Symtuza (updated)
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 13, Authorised, Last updated: 09/06/2022 -
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Human medicine European public assessment report (EPAR): Rozlytrek (updated)
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,, , Revision: 4, Authorised, Last updated: 27/06/2022
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Human medicine European public assessment report (EPAR): Brukinsa
zanubrutinib, Waldenstrom Macroglobulinemia
Date of authorisation: 22/11/2021,, Revision: 3, Authorised, Last updated: 03/05/2022
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Human medicine European public assessment report (EPAR): Lorviqua
Lorlatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/05/2019,, , Revision: 9, Authorised, Last updated: 07/04/2022