18 results
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Opinion/decision on a Paediatric investigation plan (PIP): hydrocortisone (hemisuccinate)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neonatology-Paediactric Intensive care
PIP number: EMEA-002305-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 04/12/2019, Last updated: 03/04/2020, Compliance check: Xpublic enquiries Laboratoire Aguettant E-mail: infoscientifique@aguettant.fr … -
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National expert: Iwona Korzeniewska-Rybicka, The Office for Registration of Medicinal Products, Medical Devices and Biocides (updated)
- Declaration of interests - 79.93 KB | PDF
- Curriculum Vitae - 29.05 KB | PDF
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Human medicine European public assessment report (EPAR): Arixtra (updated)
fondaparinux sodium, Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction, Angina, Unstable
Date of authorisation: 20/03/2002, Revision: 30, Authorised, Last updated: 22/02/2021 -
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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Date of authorisation: 21/03/2002, Revision: 10, Withdrawn, Last updated: 16/05/2008 -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: 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: 12/03/2014Cardene IV Loxen Nicardipine Aguettant Nicardipine Arrow Rydene … -
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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: 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, 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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Public data from Article 57 database (updated)
Last updated: 16/02/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): N-Acetyl-L-Cysteine (corresponds to L-Cysteine), L-Alanine, L-Alanyl-L-Glutamine (corresponds to L-Alanine and L-Glutamine), L-Arginine, Glycine, Glycyl-L-Tyrosine (corresponds to Glycine and L-Tyrosine), L-Histidine, L-Isoleucine, L-Leucine, L-Lysine acetate (corresponds to L-Lysine), LMethionine, L-Phenylalanine, L-Proline, L-Serine, Taurine, L-Threonine, L-Tryptophan, L-Valine
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Nutrition
PIP number: EMEA-000042-PIP01-07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 07/09/2009, Last updated: 22/10/2009, Compliance check: Xi.e. trace elements from Aguettant. Shortly after the study commenced … des Enfants” (both from Aguettant). The PEDITRACE submission … -
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List of medicines under additional monitoring (updated)
Last updated: 24/02/2021 -
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Workshop on Paediatric pain
London, UK, 28/10/2004, Last updated: 28/10/2004 -
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European Union regulatory workshop on medication errors
European Medicines Agency, London, UK, from 28/02/2013 to 01/03/2013, Last updated: 13/05/2013 -
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EudraVigilance: electronic reporting
Last updated: 23/04/2020