137 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 (updated)
miglustat, Gaucher Disease
Date of authorisation: 22/03/2017,
, Revision: 5, Authorised, Last updated: 22/02/2023
Marketing-authorisation holder Piramal Critical Care B.V. Revision … -
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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: Donald Walker, European Medicines Agency (updated)
- Declaration of interests - 83 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: Jens Sonksen, European Medicines Agency (updated)
- Declaration of interests - 84.5 KB | PDF
- Curriculum Vitae - 53 KB | PDF
cancer 01/2013-02/2014 Orexo alfentanil pain control during prostate … -
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National expert: Nicolino Ruperto, European Medicines Agency (updated)
- Declaration of interests - 83.27 KB | PDF
- Curriculum Vitae - 25.34 KB | PDF
Rheumatol 2014;53:968-974. 21. Piram M, et al Ruperto N, for EUROFEVER … -
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National expert: Marianne Patt, Federal Institute For Drugs And Medical Devices (updated)
- Declaration of interests - 81.08 KB | PDF
- Curriculum Vitae - 43.51 KB | PDF
01/2010-12/2016 Bayer Schering Pharma/Piramal/LMI Florbetaben/PI2620 diagnostic … -
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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: 15, Authorised, Last updated: 13/12/2022 -
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Human medicine European public assessment report (EPAR): Prezista (updated)
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 54, Authorised, Last updated: 03/03/2023 -
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Human medicine European public assessment report (EPAR): Vfend
voriconazole, Candidiasis; Mycoses; Aspergillosis
Date of authorisation: 19/03/2002, Revision: 52, Authorised, Last updated: 13/02/2023 -
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Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,
, Revision: 14, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Akynzeo (updated)
netupitant, palonosetron hydrochloride, Vomiting; Neoplasms; Nausea; Cancer
Date of authorisation: 27/05/2015, Revision: 15, Authorised, Last updated: 20/02/2023 -
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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 9, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d.
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 8, Withdrawn, Last updated: 03/02/2023
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Human medicine European public assessment report (EPAR): Tavneos
Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022,
, , Revision: 2, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Zejula
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 19, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Kisqali
ribociclib succinate, Breast Neoplasms
Date of authorisation: 22/08/2017, Revision: 13, Authorised, Last updated: 07/02/2023 -
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Human medicine European public assessment report (EPAR): Ayvakyt (updated)
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,, , 
, Revision: 6, Authorised, Last updated: 14/03/2023
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Human medicine European public assessment report (EPAR): Tukysa (updated)
Tucatinib, Breast Neoplasms; Neoplasm Metastasis
Date of authorisation: 11/02/2021,, Revision: 3, Authorised, Last updated: 27/02/2023
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Human medicine European public assessment report (EPAR): Darunavir Mylan
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 12, Authorised, Last updated: 04/11/2022
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , , Revision: 8, Authorised, Last updated: 22/12/2022
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Human medicine European public assessment report (EPAR): Imatinib Accord
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: 20, Authorised, Last updated: 14/12/2022