34 results
Keyword Riges Remove keyword
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Referral: Rigevidon
levonorgestrel, ethinylestradiol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/01/2005, EC decision date: 10/05/2005, Last updated: 08/06/2005Rigevidon … Commission final decision Overview Rigevidon is a combined oral contraceptive … Marketing Authorisation for Rigevidon was granted to Medimpex France … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fostamatinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001196-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Last updated: 27/11/2018, Compliance check: Ximmunomodulation Oral use Rigel Pharmaceuticals Ltd E-mail: … Pharmaceuticals Ltd E-mail: dvance@rigel.com Tel. +44 (0)1603 693204 … -
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Orphan designation: (S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile (olutasidenib) for: Treatment of acute myeloid leukaemia
Date of designation: 29/05/2019, Positive, Last updated: 23/01/2023leukaemiaPositiveEU/3/19/2159 29/05/2019 Rigel Pharmaceuticals B.V. Avenue … Clinipace GmbH, Germany to Rigel Pharmaceuticals B.V., The … -
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Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand for: Treatment of pancreatic cancer
Date of designation: 19/11/2018, Positive, Last updated: 20/02/2019the European Commission to Rigenerand S.r.l., Italy, for autologous … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 13-16 September 2004
Last updated: 16/09/2004Community-wide review for Rigevidon (levonorgestrel and ethinylestradiol … Community-wide review for Rigevidon (levonorgestrel and ethinylestradiol … -
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COVID-19 treatments: research and development
Last updated: 06/10/2022Clinical phase Fostamatinib Rigel Immunomodulator Clinical …
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Human medicine European public assessment report (EPAR): Idacio
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 02/04/2019,
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, Revision: 10, Authorised, Last updated: 18/10/2022
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019 (updated)
CHMP, Last updated: 15/11/2019Marketing-authorisation applicant Rigel Pharmaceuticals B.V. Therapeutic … -
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National expert: Jens Sonksen, European Medicines Agency (updated)
- Declaration of interests - 84.5 KB | PDF
- Curriculum Vitae - 53 KB | PDF
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Referral: Combined hormonal contraceptives
desogestrel, gestodene, norgestimate, etonogestrel, drospirenone, dienogest, chlormadinone, nomegestrol, norelgestromin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/01/2014, Last updated: 31/01/2014 -
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Referral: Emergency contraceptives
levonorgestrel, ulipristal acetate, associated names: Norlevo, Levonelle/Postinor and Levodonna, ellaOne, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/07/2014, EC decision date: 30/09/2014, Last updated: 24/10/2014 -
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Referral: Domperidone-containing medicines
domperidone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 01/09/2014, Last updated: 11/09/2014 -
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Orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase) for: Prevention of graft rejection following solid organ transplantation
Date of designation: 12/01/2017, Positive, Last updated: 28/08/2020 -
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Orphan designation: ciclosporin for: Prevention of graft rejection after lung transplantation
Date of designation: 29/07/2004, Positive, Last updated: 10/07/2019 -
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Orphan designation: Murine IgM monoclonal antibody binding to alpha beta T-cell receptor for: Prevention of graft rejection following solid organ transplantation
Date of designation: 12/03/2013, Withdrawn, Last updated: 17/07/2017 -
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Orphan designation: Dexamethasone phosphate for: Treatment of corneal graft rejection
Date of designation: 15/05/2009, Withdrawn, Last updated: 21/10/2016 -
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Orphan designation: ciclosporin for: Prevention of graft rejection after lung transplantation
Date of designation: 10/03/2005, Withdrawn, Last updated: 21/10/2016 -
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Orphan designation: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser (cibinetide) for: Prevention of graft loss in pancreatic islet transplantation
Date of designation: 29/08/2016, Positive, Last updated: 03/10/2016 -
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Orphan designation: Reparixin for: Prevention of graft loss in pancreatic islet transplantation
Date of designation: 27/09/2011, Positive, Last updated: 13/05/2015Prevenzione delle crisi di rigetto dopo trapianto di isole pancreatiche … -
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Orphan designation: ciclosporin for: Prevention of corneal graft rejection
Date of designation: 22/10/2007, Positive, Last updated: 13/05/2015Ciclosporina Prevenzione del rigetto nel trapianto di cornea Latvian … -
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Orphan designation: Recombinant monoclonal IgG1 antibody against T-cell immune response cDNA 7 for: Prevention of graft rejection following solid organ transplantation
Date of designation: 24/04/2015, Positive, Last updated: 22/05/2015 -
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Orphan designation: Eculizumab for: Prevention of graft rejection following solid organ transplantation
Date of designation: 26/03/2014, Withdrawn, Last updated: 26/03/2015 -
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Orphan designation: ciclosporin for: Treatment of graft rejection after lung transplantation
Date of designation: 10/03/2005, Withdrawn, Last updated: 23/03/2015 -
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Orphan designation: Ex-vivo cultured human mesenchymal stromal cells for: Prevention of graft rejection following solid organ transplantation
Date of designation: 26/03/2014, Positive, Last updated: 06/05/2014 -
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Orphan designation: Autologous regulatory T cells with an immunophenotype of CD4+CD25hiFoxP3+ for: Prevention of rejection following solid organ transplantation
Date of designation: 08/10/2013, Positive, Last updated: 03/12/2013