164 results
Keyword Aria Medicair Remove keyword
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Press release: PRAC updates on the risks of serious vascular occlusive events associated with cancer medicine Iclusig
Last updated: 08/11/2013holder for this medicine is Ariad. Iclusig is an orphan medicinal … holder for this medicine is Ariad. 3. Iclusig is an orphan … -
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National expert: Monika Brüggemann, European Medicines Agency (updated)
- Declaration of interests - 82.67 KB | PDF
- Curriculum Vitae - 31.08 KB | PDF
malignancies 03/2020-(current) ARIAD Pharmaceuticals (now Incyte … -
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Orphan designation: Ponatinib hydrochloride for: Treatment of gastrointestinal stromal tumours
Date of first decision: 15/01/2015, Positive, Last updated: 10/02/2017the European Commission to ARIAD Pharma Ltd, United Kingdom … the European Commission to ARIAD Pharma Ltd, United Kingdom … Sponsor’s contact details: ARIAD Pharma Ltd Riverbridge House … -
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2013 European Medicines Agency / International Federation for Animal Health Europe info day
European Medicines Agency, London, UK, from 07/03/2013 to 08/03/2013, Last updated: 08/04/2013– industry perspective (Ariane van de Moer) (PDF/203.13 KB … -
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National expert: Patrizia Iacovacci, Italian Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 21.86 KB | PDF
R. Federico, M.E. Schininà, R. Ariano, G. Di Felice, C. Pini. Rapid … Iacovacci, R. Tinghino, R. Ariano, R.C. Panzani, G. Di Felice … Barletta, R. Tinghino, R. Ariano,R.C. Panzani, G. Di Felice, C … -
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National expert: Anne-Isabelle Waechter, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 18.65 KB | PDF
A. INCHAUSTI, A. ROJAS DE ARIAS, R. HOCQUEMILLER ET A.-I … A. INCHAUSTI, A. ROJAS DE ARIAS, R. HOCQUEMILLER, A. CAVE … FERREIRA, A. FOURNET, A. ROJAS DE ARIAS, H. NAKAYAMA, S. TORRES, R … -
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Orphan designation: Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl] (ponatinib) for: Treatment of chronic myeloid leukaemia
Date of first decision: 02/02/2010, Positive, Last updated: 23/03/2015the European Commission to Ariad Pharma Ltd, United Kingdom … the European Commission to ARIAD Pharma Ltd, United Kingdom … -
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Orphan designation: Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl] (ponatinib) for: Treatment of acute lymphoblastic leukaemia
Date of first decision: 02/02/2010, Positive, Last updated: 23/03/2015the European Commission to Ariad Pharma Ltd, United Kingdom … the European Commission to Ariad Pharma Ltd, United Kingdom … -
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National expert: Fakhredin Sayed Tabatabaei, Medicines Evaluation Board (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 22.82 KB | PDF
HM, Verberne GJ, Visser FE, Arias-Vasquez A, Sayed-Tabatabaei FA, Vergeer-Drop … -
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National expert: Maurizio Volterrani, Italian Medicines Agency (updated)
- Declaration of interests - 83.5 KB | PDF
- Curriculum Vitae - 19.67 KB | PDF
EFFECT-HF, AUGMENT-HF, TOSCA ARIADNE, VICTORIA, GALACTIC-HF, AMG … GALACTIC-HF, AMG 20110203, ARIADNE. EMPERIAL, FAIR-HF , EMPULSE … -
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National expert: Johann Lodewijk Hillege, Medicines Evaluation Board (updated)
- Declaration of interests - 80.13 KB | PDF
- Curriculum Vitae - 20.85 KB | PDF
Principal investigator ARIANA-CHF-RD, a double-blind, placebo-controlled … -
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National expert: David Sanz Rosa, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 109.13 KB | PDF
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Human medicine European public assessment report (EPAR): Triumeq (updated)
dolutegravir sodium, lamivudine, abacavir (as sulfate), HIV Infections
Date of authorisation: 31/08/2014, Revision: 20, Authorised, Last updated: 26/02/2021 -
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012,
, Revision: 11, Authorised, Last updated: 25/02/2021
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Human medicine European public assessment report (EPAR): Azomyr (updated)
desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 45, Authorised, Last updated: 04/03/2021 -
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Human medicine European public assessment report (EPAR): Neoclarityn (updated)
desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 39, Authorised, Last updated: 24/02/2021 -
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis, Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 17, Authorised, Last updated: 24/02/2021
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,
, Revision: 10, Authorised, Last updated: 20/11/2020
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National expert: Eva Skovlund, Norwegian Medicines Agency (updated)
- Declaration of interests - 80.01 KB | PDF
- Curriculum Vitae - 52.58 KB | PDF
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Human medicine European public assessment report (EPAR): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,
, , Revision: 2, Authorised, Last updated: 04/06/2020
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National expert: Giovanni Fiori, European Medicines Agency (updated)
- Declaration of interests - 80.71 KB | PDF
- Curriculum Vitae - 21.01 KB | PDF
Mateu E, Bosch E, Martínez-Arias R, Clarimón J, Fiori G … Pérez-Lezaun A, Bosch E, Martínez-Arias R, Clarimon J, Facchini F … -
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Human medicine European public assessment report (EPAR): Iclusig
ponatinib, Leukemia, Myeloid, Leukemia, Lymphoid
Date of authorisation: 01/07/2013,
, , , Revision: 20, Authorised, Last updated: 29/10/2019
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Human medicine European public assessment report (EPAR): Tremfya
guselkumab, Psoriasis
Date of authorisation: 10/11/2017,, Revision: 5, Authorised, Last updated: 22/01/2021
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Human medicine European public assessment report (EPAR): Scintimun
besilesomab, Osteomyelitis, Radionuclide Imaging
Date of authorisation: 11/01/2010, Revision: 5, Authorised, Last updated: 27/10/2016