38 results
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Human medicine European public assessment report (EPAR): Dzuveo
sufentanil citrate, Pain
Date of authorisation: 25/06/2018, Revision: 3, Authorised, Last updated: 13/01/2022Publication details >Laboratoire Aguettant3 25/06/2018 Laboratoire Aguettant … -
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Opinion/decision on a Paediatric investigation plan (PIP): hydrocortisone (hemisuccinate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neonatology-Paediactric Intensive care
PIP number: EMEA-002305-PIP01-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 09/09/2020, Last updated: 02/07/2021, Compliance check: XIntravenous use Laboratoire Aguettant E-mail: infoscientifique@aguettant.fr … submitted by Laboratoire Aguettant on 16 April 2020 under Article … addressed to Laboratoire Aguettant, 1 rue Alexander Fleming … -
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Orphan designation: Hydrocortisone hydrogen succinate for: Prevention of bronchopulmonary dysplasia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022dysplasiaPositiveEU/3/21/2452 21/06/2021 Laboratoire Aguettant 1 Rue Alexander Fleming 69007 … -
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National expert: Iwona Korzeniewska-Rybicka, The Office for Registration of Medicinal Products, Medical Devices and Biocides (updated)
- Declaration of interests - 79.96 KB | PDF
- Curriculum Vitae - 29.35 KB | PDF
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Referral: Intravenous nicardipine medicines
nicardipine, associated names: Cardene IV, Loxen, Nicardipine Aguettant, Nicardipine Arrow, Rydene, Vasonase, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/10/2013, EC decision date: 20/12/2013, Last updated: 12/03/2014 -
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Human medicine European public assessment report (EPAR): Arixtra
fondaparinux sodium, Venous Thrombosis; Pulmonary Embolism; Myocardial Infarction; Angina, Unstable
Date of authorisation: 20/03/2002, Revision: 33, Authorised, Last updated: 24/11/2021 -
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Human medicine European public assessment report (EPAR): Quixidar
fondaparinux sodium, Venous Thrombosis; Pulmonary Embolism; Myocardial Infarction; Angina, Unstable
Date of authorisation: 21/03/2002, Revision: 10, Withdrawn, Last updated: 16/05/2008 -
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Referral: Bisphosphonates
alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, associated names: Actonel, Aredia, Bonefos, Didronel, Fosamax, Nerixia, Skelid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 13/07/2011, Last updated: 28/10/2011 -
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Referral: Valproate and related substances
sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide, associated names: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/03/2018, EC decision date: 31/05/2018, Last updated: 07/06/2018 -
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Referral: Valproate and related substances
sodium valproate, valproic acid, valproate semisodium, valpromide, associated names: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel, Article 31 referrals
Status: CMDh final position, opinion/position date: 19/11/2014, Last updated: 29/01/2015 -
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Referral: Adrenaline auto-injectors
adrenaline (epinephrine), Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/06/2015, EC decision date: 14/08/2015, Last updated: 26/08/2015 -
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Referral: Hydroxyethyl starch solutions for infusion
hydroxyethyl starch, Article 107i procedures
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 06/03/2014 -
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Referral: Hydroxyethyl starch solutions for infusion
hydroxyethyl starch, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 12/01/2018 -
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Orphan designation: Humanised IgG2 monoclonal antibody against TNFSF13 for: Treatment of primary IgA nephropathy
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: L-ergothioneine for: Treatment of cystinuria
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Tislelizumab for: Treatment of nasopharyngeal cancer
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Adeno-associated virus serotype 9 expressing human CLN5 for: Treatment of neuronal ceroid lipofuscinosis
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Allogenic placenta-derived mesenchymal stromal cells secretome for: Treatment of pre-eclampsia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: imatinib for: Treatment of pulmonary arterial hypertension
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropane-2-yl)-1H-pyrazole-4-carboxamide for: Treatment of mantle cell lymphoma
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Bomedemstat ditosilate for: Treatment of essential thrombocythaemia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: melatonin for: Prevention of retinopathy of prematurity
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Humanised monoclonal antibody derivative against fibroblast growth factor receptor 3 for: Treatment of achondroplasia
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: H-D-valyl1-D-alanyl-D-glutamyl-D-alanyl-D-arginyl5-D-glutamyl-D-glutamyl-D-leucyl-D-glutamyl-D-arginyl10-D-leucyl-D-glutamyl-D-alanyl-D-arginyl-D-leucyl15-glycyl-D-glutaminyl-D-alanyl-D-arginyl-glycyl20-D-glutamyl-D-leucyl-D-lysyl-D-lysyl-D-tryptophyl25-D-lysyl-D-methionyl-D-arginyl-D-arginyl-D-asparaginyl30-D-glutaminyl-D-phenylalanyl-D-tryptophyl-D-leucyl-D-lysyl35-D-leucyl-D-glutaminyl-D-arginine for: Treatment of glioma
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022 -
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Orphan designation: Adeno-associated virus serotype 9 containing the human FXN gene isoform 1 for: Treatment of Friedreich's ataxia
Date of designation: 21/06/2021, Withdrawn, Last updated: 11/05/2022