396 results
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Referral: Furosemide Vitabalans
furosemide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/02/2013, EC decision date: 14/05/2013, Last updated: 30/07/2013Furosemide Vitabalans … Questions and answers on Furosemide Vitabalans (tablet, 40 mg … Questions and answers on Furosemide Vitabalans (tablet, 40 mg … -
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Opinion/decision on a Paediatric investigation plan (PIP): Furosemide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-000982-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Orodispersible tablet
Decision date: 21/10/2011, Last updated: 02/10/2018, Compliance check: XKey facts Furosemide Uro-nephrologyP/245/2011EMEA-000982-PIP01-10 … granting of a waiver for furosemide (EMEA-000982-PIP01-10) PDF … EMA/826074/2011 Generic Related content Furosemide - Notification of discontinuation … -
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Opinion/decision on a Paediatric investigation plan (PIP): eplerenone, Furosemide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003065-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 03/12/2021, Last updated: 13/03/2023, Compliance check: XKey facts eplerenone Furosemide Cardiovascular diseasesP/0488/2021EMEA-003065-PIP01-21 … specific waiver for eplerenone / furosemide (EMEA-003065-PIP01-21) PDF … specific waiver for eplerenone / furosemide (EMEA-003065-PIP01-21) in … -
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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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Veterinary medicine European public assessment report (EPAR): UpCard
Torasemide anhydrous, Dogs
Date of authorisation: 31/07/2015, Revision: 2, Authorised, Last updated: 29/09/2020treatment with the diuretic furosemide. The main measure of effectiveness … at least as effective as furosemide for treatment of signs related … treatment with the diuretic furosemide. The main measure of effectiveness … -
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Veterinary medicine European public assessment report (EPAR): Isemid
Torasemide, Dogs
Date of authorisation: 09/01/2019, Authorised, Last updated: 07/02/2019established diuretic medicine, furosemide. The main measure of effectiveness … as least as effective as furosemide for the treatment of signs … -
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National expert: Alessandra Renieri, European Medicines Agency (updated)
- Declaration of interests - 41.52 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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 February 2013
CHMP, Last updated: 22/02/2013Furosemide Vitabalans 40 mg tablets … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2012
CHMP, Last updated: 19/10/2012Marketing-authorisation applicant Furosemide Vitabalans furosemide Vitabalans Oy Levothyroxine … -
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Referral: Vasotop P
ramipril, Article 13
Status: European Commission final decision, opinion/position date: 08/12/2009, EC decision date: 27/04/2010, Last updated: 14/08/2014without adjunct diuretic (furosemide) or cardiac glycoside (digoxin/methyldigoxin … without adjunct diuretic (furosemide) or cardiac glycoside (digoxin/methyldigoxin … without adjunct diuretic (furosemide) or cardiac glycocide (digoxin/methyldigoxin … -
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National expert: Irmeli Happonen, Finnish Medicines Agency (updated)
- Declaration of interests - 40.02 KB | PDF
- Curriculum Vitae - 37.19 KB | PDF
douple_unit controlled release furosemide tablets. Acta Pharm Fenn … of ethylcellulose_coated furosemide tablets as a prolonged_release … on the bioavailability of furosemide from press_coated prolonged_release … -
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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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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: Brigitte Schwarzer-Daum, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 39.86 KB | PDF
- Curriculum Vitae - 207.38 KB | PDF
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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: Pia Rivetti di Val Cervo, Italian Medicines Agency (updated)
- Declaration of interests - 39.33 KB | PDF
- Curriculum Vitae - 33.13 KB | PDF
epidermal differentiation and senescence, as well as brain morphogenesis. • … E.“MicroRNA_191 triggers keratinocytes senescence by SATB1 and CDK6 downregulation.” … feedback in keratinocyte senescence.” Proc Natl Acad Sci USA 109 … -
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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: Christophe Richez, European Medicines Agency (updated)
- Declaration of interests - 60.86 KB | PDF
- Curriculum Vitae - 29.16 KB | PDF
Barnetche T, Duffau P, Couzi L, Seneschal J, Blanco P, Lazaro E, Richez … Duffau P, Truchetet ME, Seneschal J, Couzi L, Pellegrin JL … Barnetche T, Blanco P, Lazaro E, Seneschal J, Truchetet ME, Duffau P … -
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National expert: Federica Chiara, European Medicines Agency (updated)
- Declaration of interests - 40.45 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: 15, Authorised, Last updated: 20/02/2023 -
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Human medicine European public assessment report (EPAR): Verzenios
abemaciclib, Breast Neoplasms
Date of authorisation: 26/09/2018,
, Revision: 9, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Adasuve
loxapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/02/2013, Revision: 14, Authorised, Last updated: 14/11/2022 -
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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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Human medicine European public assessment report (EPAR): Ibrance (updated)
Palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016,, Revision: 15, Authorised, Last updated: 22/05/2023
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Human medicine European public assessment report (EPAR): Okedi (updated)
Risperidone, Schizophrenia
Date of authorisation: 14/02/2022, Revision: 2, Authorised, Last updated: 30/05/2023