20411 results
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Human medicine European public assessment report (EPAR): Kesimpta
Ofatumumab, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 26/03/2021,
, Revision: 6, Authorised, Last updated: 31/03/2023
Diseases Autoimmune Diseases of the Nervous System Demyelinating … adults with relapsing forms of multiple sclerosis (MS … have relapses and/or signs of active inflammation on scans … -
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Human medicine European public assessment report (EPAR): Arzerra
Ofatumumab, Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 19/04/2010, Revision: 16, Withdrawn, Last updated: 10/05/2019information documents contain: summary of product characteristics (annex … release (annex IIA); conditions of the marketing authorisation (annex … Arzerra ofatumumab Ofatumumab … -
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Veterinary medicine European public assessment report (EPAR): Syvazul BTV
Inactivated bluetongue virus, serotype 1, strain ALG2006/01 E1, Inactivated bluetongue virus, serotype 4, strain BTV-4/SPA-1/2004, Inactivated bluetongue virus, serotype 8, strain BEL2006/01, Cattle; Sheep
Date of authorisation: 09/01/2019, Revision: 3, Authorised, Last updated: 20/01/202221 days after completion of the initial vaccination course … protection lasts one year. Groups of 25 calves from 2 months of age (with no antibodies to … sufficient to show effectiveness of the BTV-4 vaccine. What are … -
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Orphan designation: Mixture of two adeno-associated viral vectors of serotye 8 containing the 5'-half sequence of human ABCA4 gene and the 3'-half sequence of human ABCA4 gene for: Treatment of Stargardt's disease
Date of designation: 04/07/2014, Positive, Last updated: 07/11/2022summary of opinion … Public summary of opinion on orphan designation Mixture … orphan designation Mixture of two adeno-associated viral … -
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Herbal medicinal product: Sisymbrii officinalis herba
Sisymbrium officinale (L.) Scop., Hedge mustard, F: Assessment finalised, Last updated: 13/04/2022Sisymbrii officinalis herba Mouth and throat disorders Cough … preparing the Agency’s opinions on questions relating to … preparing the Agency’s opinions on questions relating to … -
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Human medicine European public assessment report (EPAR): Spherox
spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases
Date of authorisation: 10/07/2017, Revision: 8, Authorised, Last updated: 20/02/2023CHMP post-authorisation summary of positive opinion for Spherox (II-20) (PDF/108.03 … Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … -
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Herbal medicinal product: Salviae officinalis aetheroleum
Salvia officinalis L., Sage Oil, F: Assessment finalised, Last updated: 31/12/2009Salviae officinalis aetheroleum … preparing the Agency’s opinions on questions relating to … preparing the Agency’s opinions on questions relating to … -
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Veterinary medicine European public assessment report (EPAR): Enteroporc Coli
Inactivated fimbrial adhesins of Escherichia coli F4ab, Inactivated fimbrial adhesins of Escherichia coli F4ac, Inactivated fimbrial adhesins of Escherichia coli F5, Inactivated fimbrial adhesins of Escherichia coli F6, Pigs
Date of authorisation: 06/01/2021, Revision: 1, Authorised, Last updated: 12/05/2021detail is available in the summary of product characteristics This … Official address Domenico Scarlattilaan … The Netherlands An agency of the European Union Address … -
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Withdrawn application: Arzerra
ofatumumab, date of withdrawal: 08/11/2016, Post-authorisation, Last updated: 16/12/2016United Kingdom An agency of the European Union Telephone … and answers Withdrawal of the application for a change … authorisation for Arzerra (ofatumumab) On 8 November 2016 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Kesimpta, Ofatumumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002397-PIP01-18-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/04/2022, Last updated: 19/04/2023, Compliance check: XKesimpta Active substance Ofatumumab Therapeutic area Neurology … indication(s) Treatment of multiple sclerosis Route(s of administration Subcutaneous … application for modification of an agreed PIP … -
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Human medicine European public assessment report (EPAR): Palforzia
defatted powder of Arachis hypogaea L., semen (peanuts), Peanut Hypersensitivity
Date of authorisation: 17/12/2020,, Revision: 5, Authorised, Last updated: 19/09/2022
indicated for the treatment of patients aged 4 to 17 years … with a confirmed diagnosis of peanut allergy. Palforzia … continued in patients 18 years of age and older. Palforzia … -
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Orphan designation: Recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule for: Treatment of glioma
Date of designation: 28/01/2010, Positive, Last updated: 25/02/2010EU/3/09/709: Public summary of opinion on orphan designation of recombinant fusion protein … www.ema.europa.eu An agency of the European Union © … Medicinal Products Public summary of opinion on orphan designation Recombinant … -
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Orphan designation: Recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule for: Prevention of graft-versus-host disease
Date of designation: 31/10/2006, Positive, Last updated: 02/04/2009EU/3/06/411: Public summary of positive opinion for orphan designation of recombinant fusion protein … fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule for … -
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Herbal medicinal product: Taraxaci officinalis radix
Taraxacum officinale F.H. Wigg., Dandelion root, F: Assessment finalised, Last updated: 21/06/2022Taraxaci officinalis radix Loss of appetite Urinary tract and … information. Key facts Taraxaci officinalis radixDandelion rootTaraxacum officinale F.H. Wigg. Loss of appetiteUrinary tract and … Taraxaci officinalis radix Taraxacum officinale F.H. Wigg. Dandelion root … -
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Herbal medicinal product: Salviae officinalis folium
Salvia officinalis L., Sage Leaf, F: Assessment finalised, Last updated: 13/07/2017Salviae officinalis folium Mouth and throat … Opinion of the HMPC on a European Union … herbal monograph on Salvia officinalis L., folium - Revision 1 (PDF/115.8 … -
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Orphan designation: Mixture of two adeno-associated viral vectors serotype 8 containing the 5'-half sequence of human MYO7A gene and the 3'-half sequence of human MYO7A gene for: Treatment of Usher syndrome
Date of designation: 04/07/2014, Positive, Last updated: 07/11/2022summary of opinion … Public summary of opinion on orphan designation Mixture … orphan designation Mixture of two adeno-associated viral … -
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Orphan designation: Combination of three adeno-associated viral vectors of serotype 8 containing the 5'-, the body- and the 3'- coding sequences of human CEP290 fused to inteins for: Treatment of inherited retinal dystrophies
Date of designation: 28/02/2020, Positive, Last updated: 07/11/2022EU/3/20/2254: Public summary of positive opinion for orphan designation of combination … Combination of three adeno-associated viral … adeno-associated viral vectors of serotype 8 containing the … -
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Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of beta thalassaemia intermedia and major
Date of designation: 29/07/2014, Positive, Last updated: 21/03/2023EU/3/14/1300: Public summary of opinion on orphan designation: Recombinant … fusion protein consisting of a modified form of the extracellular domain … Public summary of opinion on orphan designation Recombinant … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ofev, nintedanib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001006-PIP02-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 27/10/2015, Last updated: 11/07/2016, Compliance check: XPublic summary of the evaluation of a proposed paediatric investigation … Nintedanib for the treatment of systemic sclerosis (PDF/85.76 … United Kingdom An agency of the European Union Telephone … -
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Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of myelodysplastic syndromes
Date of designation: 22/08/2014, Positive, Last updated: 18/02/2021EU/3/14/1331: Public summary of opinion on orphan designation: Recombinant … fusion protein consisting of a modified form of the extracellular domain … Public summary of opinion on orphan designation Recombinant … -
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Orphan designation: humanised fusion protein consisting of extracellular domain of CD24 linked to IgG1 Fc domain for: Prevention of graft-versus-host disease
Date of designation: 11/11/2015, Positive, Last updated: 24/09/2021EU/3/15/1575: Public summary of opinion on orphan designation: Humanised … fusion protein consisting of extracellular domain of CD24 linked to IgG1 Fc domain … Public summary of opinion on orphan designation Humanised … -
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Orphan designation: Mixture of seven synthetic fragments consisting of p21 RAS peptides for: Treatment of pancreatic cancer
Date of designation: 05/08/2011, Positive, Last updated: 08/07/2021EU/3/11/885: Public summary of opinion on orphan designation: Mixture … orphan designation: Mixture of seven synthetic fragments … PSO 007-11 Mixture of seven synthetic fragments … -
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Orphan designation: Combination of two adeno-associated viral vectors of serotype 8 containing the 5'- and the 3'- half coding sequences of human ABCA4 fused to inteins for: Treatment of Stargardt's disease
Date of designation: 17/10/2019, Positive, Last updated: 07/11/2022Telethon, Italy, for combination of two adeno-associated viral … adeno-associated viral vectors of serotype 8 containing the … 3'- half coding sequences of human ABCA4 fused to inteins … -
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Human medicine European public assessment report (EPAR): Ofev
nintedanib, Idiopathic Pulmonary Fibrosis
Date of authorisation: 14/01/2015,
, Revision: 22, Authorised, Last updated: 26/04/2022
Ofev Cancer Neoplasms Pulmonary … Ofev is a medicine used to treat … fibrosis (IPF), a disease of unknown cause in which fibrous … -
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Herbal medicinal product: Calendulae flos
Calendula officinalis L., Calendula Flower, F: Assessment finalised, Last updated: 02/07/2018Overview This is a summary of the scientific conclusions … preparing the Agency’s opinions on questions relating to … preparing the Agency’s opinions on questions relating to …