2543 results
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Veterinary medicine European public assessment report (EPAR): Nobilis IB Primo QX
live avian infectious bronchitis virus, strain D388, Chicken
Date of authorisation: 04/09/2014, Revision: 5, Authorised, Last updated: 26/04/2021infectious bronchitis virus strain D388 Overview Nobilis IB Primo … variants, such as strain D388. Nobilis IB Primo QX contains … infectious bronchitis virus strain D388 as the active substance … -
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Opinion/decision on a Paediatric investigation plan (PIP): strontium succinate, vitamin D3
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001131-PIP02-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: Xstrontium succinate vitamin D3 Immunology-Rheumatology-TransplantationP/0029/2013EMEA-001131-PIP02-12 … strontium succinate / Vitamin D3, (EMEA-001131-PIP02-12) PDF … strontium succinate / Vitamin D3, (EMEA-001131-PIP02-12 … -
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Human medicine European public assessment report (EPAR): Respreeza
Human alpha1-proteinase inhibitor, Genetic Diseases, Inborn; Lung Diseases
Date of authorisation: 20/08/2015,
, Revision: 10, Authorised, Last updated: 08/12/2021
alpha1-proteinase inhibitor (human … Respreeza; INN-human alpha1-proteinase inhibitor 30 Churchill … public Respreeza human alpha1-proteinase inhibitor This is a summary … -
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Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Batch-specific product recall
Active substance: alpha1-proteinase inhibitor (human), DHPC type: Quality defect, Last updated: 12/02/2021Respreeza (human alpha-1-proteinase inhibitor): Batch-specific … Respreeza (human alpha-1-proteinase inhibitor): Batch-specific … Respreeza (human alpha-1-proteinase inhibitor): batch-specific … -
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Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Sterility issue with the infusion device co-packed with Respreeza 4.000 mg and 5.000 mg
Active substance: Human alpha1-proteinase inhibitor, DHPC type: Medicine shortage, Last updated: 26/03/2021Respreeza (human alpha-1-proteinase inhibitor): Sterility issue … Respreeza (human alpha-1-proteinase inhibitor): Sterility issue … Respreeza (human alpha-1-proteinase inhibitor): Sterility issue … -
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Orphan designation: Alpha-1 antitrypsin for: Treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency
Date of designation: 16/11/2004, Positive, Last updated: 07/05/2019Alpha-1 antitrypsin Overview On 16 … Ltd, United Kingdom, for alpha-one antitrypsin (inhalation use … emphysema secondary to congenital alpha-1-antitrypsin deficiency. The sponsorship … -
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Orphan designation: alpha-tocopherol for: treatment of facioscapulohumeral muscular dystrophy
Date of designation: 18/11/2016, Positive, Last updated: 14/12/2016alpha-tocopherol Overview On 18 November 2016 … Montpellier, France, for alpha-tocopherol for the treatment of facioscapulohumeral … reaction known as oxidation. Alpha-tocopherol, a form of vitamin E, is an … -
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Orphan designation: Alpha-galactosidase A for: Treatment of Fabry disease
Date of designation: 08/08/2000, Expired, Last updated: 18/11/2011Alpha-galactosidase A Overview … Alpha-galactosidase A for the treatment of Fabry … opinion on orphan designation Alpha-galactosidase A for the treatment of Fabry … -
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Orphan designation: Alpha-galactosidase A for: Treatment of Fabry disease
Date of designation: 08/08/2000, Expired, Last updated: 18/11/2011Alpha-galactosidase A Overview Please note that … BV, the Netherlands, for alpha-galactosidase A for the treatment of Fabry … the missing or defective alpha-galactosidase in patients with Fabry disease … -
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Orphan designation: Alpha-tocotrienol quinone for: Treatment of Leigh syndrome
Date of designation: 09/12/2011, Positive, Last updated: 03/12/2019Alpha-tocotrienol quinone Overview On 9 December … BV, the Netherlands, for alpha-tocotrienol quinone for the treatment … medicine expected to work? Alpha-tocotrienol quinone is manufactured from … -
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Orphan designation: recombinant human alpha-N-acetylglucosaminidase for: Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome)
Date of designation: 19/06/2013, Withdrawn, Last updated: 19/10/2017recombinant human alpha-N-acetylglucosaminidase Overview Please note that … Kingdom, for recombinant human alpha-N-acetylglucosaminidase for the treatment of mucopolysaccharidosis … lack of an enzyme called alpha-N-acetylglucosaminidase. This enzyme is needed to … -
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Orphan designation: alpha-tocopherol, ascorbic acid for: Treatment of fragile X syndrome
Date of designation: 27/02/2017, Positive, Last updated: 31/03/2017alpha-tocopherol / ascorbic acid … opinion on orphan designation Alpha-tocopherol and ascorbic acid for treatment … opinion on orphan designation Alpha-tocopherol and ascorbic acid for treatment … -
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Orphan designation: Recombinant human acid alpha-glucosidase for: Treatment of glycogen storage disease type II (Pompe's disease)
Date of designation: 21/03/2018, Positive, Last updated: 23/05/2019Recombinant human acid alpha-glucosidase Overview On 21 March 2018 … for recombinant human acid alpha-glucosidase (also known as ATB200) for … of an enzyme called acid alpha glucosidase (GAA). This enzyme … -
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Orphan designation: Recombinant human acid alpha-glucosidase for: Treatment of glycogen storage disease type II (Pompe's disease)
Date of designation: 15/02/2001, Expired, Last updated: 10/08/2016Recombinant human acid alpha-glucosidase Overview … enough of a protein called alpha-glucosidase. This protein is an enzyme … Recombinant human acid alpha-glucosidase … -
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Orphan designation: Human IgG1 monoclonal antibody against alpha-synuclein for: Treatment of multiple system atrophy
Date of designation: 20/05/2021, Positive, Last updated: 17/03/2022monoclonal antibody against alpha-synuclein Overview This medicine was … bind to a protein called alpha-synuclein, which is found mainly in … found mainly in the brain. Alpha-synuclein is involved in multiple system … -
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Withdrawn application: Infinia
date of withdrawal: 21/06/2017, Initial authorisation, Last updated: 16/02/2018application for Infinia (alpha-1-antitrypsin) On 21 … congenital deficiency of alpha-1- antitrypsin. What is … containing the active substance alpha-1-antitrypsin (also known as … -
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Opinion/decision on a Paediatric investigation plan (PIP): alpha-R-lipoic acid choline ester tosilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002811-PIP01-20, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops
Decision date: 23/10/2020, Last updated: 22/07/2021, Compliance check: XKey facts alpha-R-lipoic acid choline ester tosilate … product specific waiver for alpha-R-lipoic acid choline ester tosilate … product specific waiver for alpha-R-lipoic acid choline ester tosilate … -
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Orphan designation: adeno-associated virus serotype 2/6 encoding human alpha-galactosidase A cDNA for: Treatment of Fabry disease
Date of designation: 09/01/2020, Positive, Last updated: 04/08/2021serotype 2/6 encoding human alpha-galactosidase A cDNA Overview On 9 January … serotype 2/6 encoding human alpha-galactosidase A cDNA (also known as ST-920 … lack of an enzyme called alpha galactosidase A, which breaks … -
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Orphan designation: Adeno-associated viral vector expressing acid alpha-glucosidase gene for: Treatment of glycogen storage disease type II (Pompe's disease)
Date of designation: 27/07/2020, Positive, Last updated: 08/12/2020viral vector expressing acid alpha-glucosidase gene Overview On 27 July … viral vector expressing acid alpha-glucosidase gene for the treatment of … of an enzyme called acid alpha glucosidase (GAA). This enzyme … -
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Orphan designation: Recombinant human acid alpha-glucosidase conjugated with mannose-6-phosphate analogues for: Treatment of glycogen storage disease type II (Pompe's disease)
Date of designation: 29/08/2016, Positive, Last updated: 03/10/2016Recombinant human acid alpha-glucosidase conjugated with mannose-6-phosphate … for recombinant human acid alpha-glucosidase conjugated with mannose-6-phosphate … of an enzyme called acid alpha glucosidase (GAA). This enzyme … -
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Orphan designation: Adeno-associated viral vector containing the human alpha-sarcoglycan gene for: Treatment of alpha-sarcoglycanopathy
Date of designation: 07/11/2008, Withdrawn, Last updated: 18/06/2014vector containing the human alpha-sarcoglycan gene Overview Please note … vector containing the human alpha sarcoglycan gene for the … gene for the treatment of alpha sarcoglycanopathy. For a … -
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Orphan designation: Adeno-associated viral vector containing the human alpha-N-acetylglucosaminidase gene for: Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome)
Date of designation: 27/10/2011, Positive, Last updated: 23/11/2011vector containing the human alpha-N-acetylglucosaminidase gene Overview On 27 October … vector containing the human alpha-N-acetylglucosaminidase gene for the treatment of … specialised type of protein) called alpha-N-acetylglucosaminidase. This enzyme is needed to … -
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Orphan designation: Alpha-1 antitrypsin for: Treatment of cystic fibrosis
Date of designation: 16/11/2004, Positive, Last updated: 25/04/2019Alpha-1 antitrypsin Overview On 16 … Ltd, United Kingdom, for alpha-1 antitrypsin (inhalation use … to fight the inflammation. Alpha-1 antitrypsin (inhalation use … -
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Orphan designation: Recombinant human alpha-1-microglobulin for: Treatment of pre-eclampsia
Date of designation: 04/07/2014, Withdrawn, Last updated: 11/05/2021Recombinant human alpha-1-microglobulin Overview … designation Recombinant human alpha-1-microglobulin for the treatment of pre-eclampsia … Sweden, for recombinant human alpha-1-microglobulin for the treatment of pre-eclampsia … -
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Orphan designation: Alpha-1 proteinase inhibitor for: Treatment of cystic fibrosis
Date of designation: 14/09/2007, Withdrawn, Last updated: 08/12/2020Alpha-1 proteinase inhibitor Overview … Behring GmbH, Germany, for alpha-1 proteinase inhibitor (inhalation … to fight the inflammation. Alpha-1 proteinase inhibitor (inhalation …