265 results
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Orphan designation: Refusal of orphan designation for the treatment of retinopathy of prematurity
Date of refusal of designation: 28/11/2022, Negative, Last updated: 23/01/2023Sponsor Industria Farmaceutica Galenica Senese S.r.l. Via Cassia Nord 351 … -
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Summary of opinion: Oxmax
Hemoglobin betafumaril (bovine), opinion date: 07/09/2023, Positive, Last updated: 08/09/2023resuscitative fluids (Lactated Ringer’s solution). The most common … resuscitative fluids (Lactated Ringer’s solution). The most common … -
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Veterinary medicine European public assessment report (EPAR): Oxyglobin
haemoglobin glutamer-200 (bovine), Dogs
Date of authorisation: 29/11/1999, Revision: 16, Authorised, Last updated: 20/10/2020diluted in a standard solution (Ringer’s lactate) used to replace … diluted in a standard solution (Ringer’s lactate) used to replace … -
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News: Public Statement on Trovan IV and Turvel IV
CHMP, Last updated: 25/02/1999for infusion with lactated Ringer's injection. The need to introduce … normal saline and lactated Ringer's injection. Specific changes … be diluted with lactated Ringer's normal saline, 0.9% sodium … -
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National expert: Alessandra Renieri, European Medicines Agency (updated)
- Declaration of interests - 41.38 KB | PDF
- Curriculum Vitae - 31.68 KB | PDF
Ospedaliera Universitaria Senese • Start date: 1993 • … Ospedaliera Universitaria Senese • Start date: 2002 • … Ospedaliero_Universitaria Senese. 1.11 Committee for Advanced … -
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Press release: PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl starch
PRAC, Last updated: 14/06/2013Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis … Hydroxyethyl Starch 130/0.42 versus Ringer’s acetate in severe sepsis … saline (salt) solutions or Ringer acetate, contain smaller … -
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National expert: Maria-Dimokleia Ziotopoulou, National Organization For Medicines (updated)
- Declaration of interests - 39.44 KB | PDF
- Curriculum Vitae - 29.7 KB | PDF
E. Papathanassoglou, S. A. Ringer, C. Mantzoros “Cord blood … -
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Press release: Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients – CMDh endorses PRAC recommendations
CMDh, Last updated: 25/10/2013saline (salt) solutions or Ringer's acetate, contain smaller … Hydroxyethyl starch 130/0.42 versus ringer’s acetate in severe sepsis … saline (salt) solutions or Ringer’s acetate, contain smaller … -
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National expert: Eleftheria Thomaidou, National Organization For Medicines (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 22.21 KB | PDF
Country: Greece 1. Employer: galenica sa • Start date: 091995 • … -
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National expert: Jeanette Birgitta Johansson, Medical Products Agency (updated)
- Declaration of interests - 42.55 KB | PDF
- Curriculum Vitae - 27.43 KB | PDF
related) qQPPV Past 01-01- 2021 01-05- 2022 Galenica AB Cross product related … -
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Press release: EMA starts new review of hydroxyethyl-starch containing medicines
PRAC, Last updated: 27/10/2017crystalloids, such as saline or Ringer's solutions, contain smaller … crystalloids, such as saline or Ringer’s solutions, contain smaller … -
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News: PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
PRAC, Last updated: 11/02/2022substances and include saline and Ringer’s solutions. In the EU, HES … -
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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: 12/01/2018Hydroxyethyl starch 130/0.42 versus ringer's acetate in severe sepsis … saline (salt) solutions or Ringer's acetate, contain smaller … Hydroxyethyl starch 130/0.42 versus ringer’s acetate in severe sepsis … -
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News: Hydroxyethyl-starch solutions for infusion recommended for suspension from the market
CMDh, Last updated: 26/07/2022substances and include saline and Ringer’s solutions. In the EU, HES … -
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National expert: Markus Weber, European Medicines Agency (updated)
- Declaration of interests - 40.87 KB | PDF
- Curriculum Vitae - 55.89 KB | PDF
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Press release: PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
PRAC, Last updated: 12/01/2018crystalloids, such as saline or Ringer's solutions, are pure electrolyte … crystalloids, such as saline or Ringer’s solutions, are pure electrolyte … crystalloids, such as saline or Ringer’s solutions, are pure electrolyte … -
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Press release: PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients
PRAC, Last updated: 11/10/2013saline (salt) solutions or Ringer's acetate, contain smaller … saline (salt) solutions or Ringer’s acetate, contain smaller … -
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National expert: Christoph Mueck, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 39.31 KB | PDF
- Curriculum Vitae - 54.59 KB | PDF
secreted proteins involved in senescence of human endothelial Page … interactions in UVB_induced senescence of human diploid fibroblasts.” … protein 6 delays replicative senescence of human fibroblasts“ Mechanisms … -
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National expert: Juan Fernando Martínez Leal, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 40.47 KB | PDF
- Curriculum Vitae - 198.55 KB | PDF
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National expert: Federica Chiara, European Medicines Agency (updated)
- Declaration of interests - 40.15 KB | PDF
- Curriculum Vitae - 206.71 KB | PDF
Molecular mechanisms of Neuronal Senescence. Proteomic, Molecular Oncology … -
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Human medicine European public assessment report (EPAR): Akynzeo
netupitant, palonosetron hydrochloride, Vomiting; Neoplasms; Nausea; Cancer
Date of authorisation: 27/05/2015, Revision: 16, Authorised, Last updated: 08/09/2023 -
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Press release: Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation
CMDh, Last updated: 26/01/2018crystalloids, such as saline or Ringer's solutions, are pure electrolyte … crystalloids, such as saline or Ringer’s solutions, are pure electrolyte … -
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Referral: Hydroxyethyl starch (HES) containing medicinal products
hydroxyethyl starch, Article 107i procedures
Status: European Commission final decision, opinion/position date: 26/10/2017, EC decision date: 17/07/2018, Last updated: 11/02/2022crystalloids, such as saline or Ringer’s solutions, are electrolyte … -
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National expert: Fernando Blanco, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 40.09 KB | PDF
- Curriculum Vitae - 36.39 KB | PDF
al. “Exploring cellular senescence as a tumor suppressor mechanism”.Rev … MV and Romero L. Cellular Senescence and Cancer. Res. Adv. Cancer … -
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National expert: Romano Danesi, European Medicines Agency (updated)
- Declaration of interests - 12.9 KB | PDF
- Curriculum Vitae - 147.05 KB | PDF