303 results
Keyword Furosemide Salf Remove keyword
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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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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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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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Adaptive pathways workshop
European Medicines Agency, UK, 08/12/2016, Last updated: 23/02/2017Generic Presentation - The Salford Lung Study (Ashley Woodcock … -
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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: 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: Jens Bate, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 41.88 KB | PDF
- Curriculum Vitae - 31.89 KB | PDF
Artemed_Fachklinik Prof. Dr. Dr. Salfeld GmbH • Start date: 041999 • … -
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Human medicine European public assessment report (EPAR): Enerzair Breezhaler
indacaterol, Glycopyrronium bromide, mometasone, Asthma
Date of authorisation: 03/07/2020, Revision: 5, Authorised, Last updated: 06/07/2023 -
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Human medicine European public assessment report (EPAR): Atectura Breezhaler
indacaterol acetate, Mometasone furoate, Asthma
Date of authorisation: 30/05/2020, Revision: 8, Authorised, Last updated: 06/07/2023 -
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Human medicine European public assessment report (EPAR): Jinarc (updated)
Tolvaptan, Polycystic Kidney, Autosomal Dominant
Date of authorisation: 27/05/2015,, Revision: 20, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane)
Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014,, Revision: 11, Authorised, Last updated: 26/04/2023
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Human medicine European public assessment report (EPAR): Relvar Ellipta (updated)
fluticasone furoate, vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 13/11/2013, Revision: 25, Authorised, Last updated: 04/09/2023 -
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Human medicine European public assessment report (EPAR): Entresto (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 19/11/2015, Revision: 18, Authorised, Last updated: 12/09/2023 -
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Human medicine European public assessment report (EPAR): Vantobra (previously Tobramycin PARI) (updated)
Tobramycin, Respiratory Tract Infections; Cystic Fibrosis
Date of authorisation: 18/02/2019, Revision: 5, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,,
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, Revision: 27, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Revinty Ellipta (updated)
fluticasone furoate, vilanterol trifenatate, Asthma
Date of authorisation: 02/05/2014, Revision: 22, Authorised, Last updated: 04/09/2023 -
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Human medicine European public assessment report (EPAR): Neparvis (updated)
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,, Revision: 18, Authorised, Last updated: 13/09/2023
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Human medicine European public assessment report (EPAR): Arava (updated)
leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic
Date of authorisation: 02/09/1999, Revision: 41, Authorised, Last updated: 25/08/2023 -
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Human medicine European public assessment report (EPAR): Bemrist Breezhaler
indacaterol, Mometasone furoate, Asthma
Date of authorisation: 30/05/2020, Revision: 5, Authorised, Last updated: 02/02/2023 -
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Human medicine European public assessment report (EPAR): Steglujan (updated)
ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 23/03/2018, Revision: 11, Authorised, Last updated: 19/09/2023 -
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Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,, Revision: 2, Authorised, Last updated: 04/08/2023