89 results
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Orphan designation: Florilglutamic acid (18F) for: Diagnosis of hepatocellular carcinoma
Date of first decision: 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: 3, Authorised, Last updated: 10/03/2020
Marketing-authorisation holder Piramal Critical Care B.V. Revision … -
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Orphan designation: Florilglutamic acid (18F) for: Diagnosis of glioma
Date of first decision: 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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National expert: Donald Walker, European Medicines Agency (updated)
- Declaration of interests - 82.4 KB | PDF
- Curriculum Vitae - 28.44 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 - 79.78 KB | PDF
- Curriculum Vitae - 17.41 KB | PDF
Manufacturing Technician Piramal Healthcare UK Ltd. (United … -
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National expert: Jens Sonksen, European Medicines Agency (updated)
- Declaration of interests - 84.15 KB | PDF
- Curriculum Vitae - 51.27 KB | PDF
cancer 01/2013-02/2014 Orexo alfentanil pain control during prostate … -
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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: 5, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 8, Authorised, Last updated: 16/02/2021
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Human medicine European public assessment report (EPAR): Truberzi (updated)
eluxadoline, Irritable Bowel Syndrome, Diarrhea
Date of authorisation: 19/09/2016,, Revision: 6, Withdrawn, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, 
, Revision: 8, Authorised, Last updated: 01/02/2021
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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: 5, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Imatinib Teva
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: 15, Authorised, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 6, Authorised, Last updated: 27/01/2021
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Human medicine European public assessment report (EPAR): Nilemdo
Bempedoic acid, Hypercholesterolemia, Dyslipidemias
Date of authorisation: 01/04/2020,, Revision: 3, Authorised, Last updated: 28/01/2021
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Human medicine European public assessment report (EPAR): Glivec (updated)
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,, Revision: 40, Authorised, Last updated: 01/03/2021
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Human medicine European public assessment report (EPAR): Dexdor
dexmedetomidine hydrochloride, Conscious Sedation
Date of authorisation: 15/09/2011, Revision: 13, Authorised, Last updated: 29/05/2020 -
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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: 9, Authorised, Last updated: 11/02/2021
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Human medicine European public assessment report (EPAR): Ibrance
palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016,, Revision: 11, Authorised, Last updated: 11/12/2020
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Human medicine European public assessment report (EPAR): Imatinib Actavis
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Hypereosinophilic Syndrome, Dermatofibrosarcoma
Date of authorisation: 17/04/2013,, Revision: 12, Authorised, Last updated: 10/09/2020
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Human medicine European public assessment report (EPAR): Neuraceq (updated)
florbetaben (18F), Radionuclide Imaging, Alzheimer Disease
Date of authorisation: 20/02/2014, Revision: 16, Authorised, Last updated: 25/02/2021 -
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Human medicine European public assessment report (EPAR): Tasigna
nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 19/11/2007, Revision: 38, Authorised, Last updated: 22/01/2021 -
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Human medicine European public assessment report (EPAR): Rubraca
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, , Revision: 5, Authorised, Last updated: 14/01/2021
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Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 7, Authorised, Last updated: 18/02/2021
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Human medicine European public assessment report (EPAR): Kisqali
ribociclib succinate, Breast Neoplasms
Date of authorisation: 22/08/2017,, Revision: 7, Authorised, Last updated: 04/11/2020
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Human medicine European public assessment report (EPAR): Feraccru (updated)
ferric maltol, Anemia, Iron-Deficiency
Date of authorisation: 18/02/2016, Revision: 12, Authorised, Last updated: 11/02/2021