16984 results
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Orphan designation: human monoclonal antibody against activin A for: Treatment of fibrodysplasia ossificans progressiva
Date of first decision: 18/11/2016, Positive, Last updated: 06/01/2020human monoclonal antibody against activin A (also known as … human monoclonal antibody against activin A for the treatment … human monoclonal antibody against activin ATreatment of fibrodysplasia … -
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Orphan designation: human monoclonal antibody against CD4 for: Treatment of cutaneous T-cell lymphoma
Date of first decision: 14/04/2004, Positive, Last updated: 10/03/2011human monoclonal antibody against CD4 for the treatment of … most often occurs in people aged between 40 and 60. It is … to cortisone), cytotoxic agents (medicines that kill cells … -
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Orphan designation: Human monoclonal antibody against Pseudomonas aeruginosa IATS-O1 for: Treatment of pneumonia caused by serotype O1 Pseudomonas aeruginosa
Date of first decision: 28/01/2010, Withdrawn, Last updated: 03/02/2021human monoclonal antibody against Pseudomonas aeruginos a IATS-O1 … antibiotics known to be effective against P. aeruginosa . These included … human monoclonal antibody against P. aeruginosa IATS-O1 might … -
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Orphan designation: Humanised monoclonal antibody against myostatin (domagrozumab) for: Treatment of Duchenne muscular dystrophy
Date of first decision: 08/02/2013, Withdrawn, Last updated: 23/10/2020humanised monoclonal antibody against myostatin for the treatment … usually starts before the age of six years. The muscle … humanised monoclonal antibody against myostatin for the treatment … -
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Orphan designation: Human monoclonal antibody against Fas ligand for: Treatment of pemphigus
Date of first decision: 09/02/2012, Positive, Last updated: 11/06/2020human monoclonal antibody against Fas ligand for the treatment … human monoclonal antibody against Fas ligand might be of significant … human monoclonal antibody against Fas ligand have been evaluated … -
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Orphan designation: Humanised IgG4 monoclonal antibody against extracellular tau for: Treatment of progressive supranuclear palsy
Date of first decision: 28/07/2015, Positive, Last updated: 29/04/2019IgG4 monoclonal antibody against extracellular tau for the … usually starts in people aged over 60 years and gradually … IgG4 monoclonal antibody against extracellular tau for the … -
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Orphan designation: Recombinant human minibody against complement component C5 for: Treatment of atypical haemolytic uraemic syndrome (aHUS)
Date of first decision: 22/09/2008, Withdrawn, Last updated: 12/04/2019recombinant human minibody against complement component C5 for … Recombinant human minibody against complement component C5 is … recombinant human minibody against complement component C5 was … -
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Orphan designation: Recombinant human minibody against complement component C5 for: Treatment of primary membranoproliferative glomerulonephritis
Date of first decision: 27/10/2011, Withdrawn, Last updated: 12/04/2019recombinant human minibody against complement component C5 for … infusion and antiplatelet agents. Patients developing end-stage … recombinant human minibody against complement component C5 have … -
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Orphan designation: Chimeric monoclonal antibody against GD2 (dinutuximab) for: Treatment of neuroblastoma
Date of first decision: 21/06/2011, Withdrawn, Last updated: 21/02/2019chimeric monoclonal antibody against GD2 for the treatment of … Chimeric monoclonal antibody against GD2 was authorised in the … chimeric monoclonal antibody against GD2 might be of significant … -
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Orphan designation: Human monoclonal antibody against human interleukin 13 for: Treatment of eosinophilic oesophagitis
Date of first decision: 13/11/2013, Positive, Last updated: 29/05/2018human monoclonal antibody against human interleukin 13 for … Human monoclonal antibody against human interleukin 13 for … Human monoclonal antibody against human interleukin 13Treatment … -
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Orphan designation: Humanised IgG1 monoclonal antibody against human eotaxin-2 for: Treatment of systemic sclerosis
Date of first decision: 19/11/2014, Positive, Last updated: 15/08/2016IgG1 monoclonal antibody against human eotaxin-2 for the treatment … IgG1 monoclonal antibody against human eotaxin-2 have been … IgG1 monoclonal antibody against human eotaxin-2 for the treatment … -
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Orphan designation: Antisense oligonucleotide directed against TGF-β2 mRNA for: Prevention of scarring post glaucoma filtration surgery
Date of first decision: 19/06/2015, Positive, Last updated: 27/07/2015oligonucleotide directed against TGF-β2 mRNA for the prevention … inside the eye to build up again. Scarring post glaucoma filtration … the eye from building up again. What is the stage of development … -
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Orphan designation: Chimeric monoclonal antibody against kappa myeloma antigen for: Treatment of multiple myeloma
Date of first decision: 22/05/2012, Withdrawn, Last updated: 08/06/2015chimeric monoclonal antibody against kappa myeloma antigen for … Chimeric monoclonal antibody against kappa myeloma antigen for … 5EU ● United Kingdom An agency of the European Union … -
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Orphan designation: Human monoclonal antibody against HLA-DR for: Treatment of chronic lymphocytic leukaemia
Date of first decision: 24/01/2006, Withdrawn, Last updated: 29/07/2008Commission to GPC Biotech AG, Germany, for human monoclonal … human monoclonal antibody against HLA-DR for the treatment … rare in people under the age of 40. Chronic lymphocytic … -
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Orphan designation: Human monoclonal antibody against HLA-DR for: Treatment of multiple myeloma
Date of first decision: 28/02/2006, Withdrawn, Last updated: 29/07/2008Commission to GPC Biotech AG, Germany, for human monoclonal … human monoclonal antibody against HLA-DR for the treatment … Human monoclonal antibody against HLA-DR could be of potential … -
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Orphan designation: Human monoclonal antibody against HLA-DR for: Treatment of Hodgkin's lymphoma
Date of first decision: 16/06/2005, Withdrawn, Last updated: 29/07/2008Commission to GPC Biotech AG, Germany, for human monoclonal … human monoclonal antibody against HLA-DR for the treatment … the body's natural defence against infection and disease. It … -
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Orphan designation: Humanised agonistic anti-CD28 monoclonal antibody for: Treatment of B-cell chronic lymphocytic leukaemia
Date of first decision: 11/04/2005, Positive, Last updated: 01/07/2005European Commission to TeGenero AG, Germany, for humanised agonistic anti-CD28 monoclonal antibody … rare in people under the age of 40. Bcell chronic lymphocytic … before. It also depends on the age, the symptoms, and the general … -
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Orphan designation: Humanised IgG1 monoclonal antibody against human eotaxin-2 for: Treatment of primary sclerosing cholangitis
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020IgG1 monoclonal antibody against human eotaxin-2 (also known … is more common in middle-aged men. Primary sclerosing cholangitis … IgG1 monoclonal antibody against human eotaxin-2 … -
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Referral: Methylphenidate Hexal
methylphenidate hydrochloride, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/07/2013, EC decision date: 09/10/2013, Last updated: 05/12/2013Methylphenidate Hexal … 2013, the European Medicines Agency completed an arbitration … medicine Methylphenidate Hexal. The Agency's Committee for Medicinal Products … -
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Veterinary medicine European public assessment report (EPAR): Purevax FeLV
feline leukaemia virus recombinant canarypox virus (vCP97), Cats
Date of authorisation: 13/04/2000, Revision: 12, Authorised, Last updated: 05/03/2021Authorised vaccine against feline leukaemia Overview … to vaccinate cats from the age of eight weeks against feline leukaemia, an illness … injection should be given in cats aged at least eight weeks, with … -
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Veterinary medicine European public assessment report (EPAR): Circovac
inactivated porcine circovirus type 2 (PCV2), Pigs (gilts and sows)
Date of authorisation: 21/06/2007, Revision: 11, Authorised, Last updated: 16/02/2021adjuvanted inactivated vaccine against porcine circovirus type 2 … Circovac. It explains how the Agency assessed this veterinary … vaccine used to protect pigs against porcine circovirus type 2 … -
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Veterinary medicine European public assessment report (EPAR): Equilis StrepE
live deletion-mutant Streptococcus equi strain TW928, Horses
Date of authorisation: 07/05/2004, Revision: 10, Authorised, Last updated: 15/02/2021Authorised live vaccine against Streptococcus equi Overview … vaccine used to protect horses against the respiratory disease caused … ● The Netherlands An agency of the European Union … -
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Veterinary medicine European public assessment report (EPAR): BTVPUR
bluetongue-virus serotype-1 antigen, bluetongue virus serotype 8 antigen, Sheep, Cattle
Date of authorisation: 17/12/2010, Revision: 12, Authorised, Last updated: 27/10/2020inactivated vaccine against bluetongue virus serotypes … inactivated adjuvanted vaccine against bluetongue disease virus … product is MERIAL. The change agreed by the CVMP concerns … -
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Referral: Alendronate HEXAL
alendronic acid (as sodium alendronate trihydrate), Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/01/2007, EC decision date: 13/04/2007, Last updated: 20/08/2007Alendronate HEXAL … decision Overview Alendronate HEXAL and associated names, 10 … post-menopausal osteoporosis. Hexal A/S submitted applications … -
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Veterinary medicine European public assessment report (EPAR): Rabigen SAG2
live attenuated rabies virus, SAG2 strain, Raccoon dogs (Nyctereutes procyonoides), Red foxes (Vulpes vulpes)
Date of authorisation: 06/04/2000, Revision: 9, Authorised, Last updated: 06/11/2018Authorised live vaccine against rabies Overview This is a … Rabigen SAG2 is a vaccine againts rabies. It is presented as … of vaccination campaigns against rabies. How does Rabigen …