118 results
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Human medicine European public assessment report (EPAR): Atosiban SUN
atosiban (as acetate), Premature Birth
Date of authorisation: 31/07/2013,
, Revision: 9, Authorised, Last updated: 09/02/2022
Atosiban SUN Obstetric Labor, Premature Obstetric … Atosiban SUN … summary for the public Atosiban SUN atosiban This is a summary of the … -
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Human medicine European public assessment report (EPAR): Tractocile
atosiban (as acetate), Premature Birth
Date of authorisation: 20/01/2000, Revision: 24, Authorised, Last updated: 30/03/2022Authorised atosiban Overview This is a summary … medicine. active substance atosiban (7.5 mg per millilitre … substance in Tractocile, atosiban, is an antagonist of the natural … -
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Human medicine European public assessment report (EPAR): Dzuveo
sufentanil citrate, Pain
Date of authorisation: 25/06/2018, Revision: 5, Authorised, Last updated: 26/10/2022Publication details >Laboratoire Aguettant5 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-Paediatric 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: Xpublic enquiries 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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2013
CHMP, Last updated: 31/05/2013Atosiban Sun … -
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National expert: Raffaella Sardelli, Italian Medicines Agency (updated)
- Declaration of interests - 80.05 KB | PDF
- Curriculum Vitae - 22.93 KB | PDF
quot;Contaminazione da alluminio in soluzioni di albumina umana: un monitoraggio … dell'attivatore della precallicreina in soluzioni di albumina umana" (Abs … -
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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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National expert: Audrey Sultana, Medicines Authority (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 18.44 KB | PDF
Authorisation Application Atosiban SUN - inc. Quality Marketing … -
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National expert: Eraldo Donnarumma, Italian Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 17.98 KB | PDF
PANORAMI E PERCORSI) "Doping: soluzione o inganno chimico? (BIF n.4/2006 … -
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National expert: Paola Minghetti, Italian Medicines Agency (updated)
- Declaration of interests - 81.41 KB | PDF
- Curriculum Vitae - 62.13 KB | PDF
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National expert: John Joseph Borg, Medicines Authority (updated)
- Declaration of interests - 80.14 KB | PDF
- Curriculum Vitae - 27.3 KB | PDF
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National expert: Antonio Portolés, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 82.88 KB | PDF
- Curriculum Vitae - 43.11 KB | PDF
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National expert: Armando Magrelli, Italian Medicines Agency (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 28.86 KB | PDF
Agency http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9 http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79 http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000094.jsp&mid=WC0b01ac0580028c79 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000049.jsp&mid=WC0b01ac05800229b9 Con Soluzioni Con Srl (Italy) Main activities … -
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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: 34, Authorised, Last updated: 11/11/2022 -
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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: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient
Article 82
Status: Under evaluation, opinion/position date: 11/05/2022, Last updated: 14/09/2022 -
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Referral: Short-acting beta-agonists
terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol, isoxsuprine, Article 31 referrals
Status: CMDh final position, opinion/position date: 23/10/2013, Last updated: 07/11/2013 -
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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: Closamectin Pour-on Solution and associated names
ivermectin, closantel, Article 78
Status: European Commission final decision, opinion/position date: 08/10/2015, EC decision date: 22/03/2016, Last updated: 31/05/2016 -
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Referral: Tylosin injection for mastitis
tylosin, Article 35
Status: European Commission final decision, opinion/position date: 16/03/2017, EC decision date: 10/07/2017, Last updated: 31/07/2017 -
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Referral: Fiprex
fipronil, Article 33
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 14/07/2014, Last updated: 14/08/2014 -
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Referral: Baytril injectable and generics
enrofloxacin, Article 35
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 01/09/2014, Last updated: 10/12/2014