159 results
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Human medicine European public assessment report (EPAR): Silodosin Recordati
silodosin, Prostatic Hyperplasia
Date of authorisation: 07/01/2019,
, Revision: 1, Authorised, Last updated: 18/11/2021
Silodosin Recordati Male Urogenital Diseases Genital … Silodosin Recordati … MEDICINAL PRODUCT Silodosin Recordati 4 mg hard capsules Silodosin … -
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Human medicine European public assessment report (EPAR): Urorec
silodosin, Prostatic Hyperplasia
Date of authorisation: 29/01/2010, Revision: 18, Authorised, Last updated: 06/04/2022European Union for Urorec to Recordati Ireland Ltd. on 29 January … -
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Opinion/decision on a Paediatric investigation plan (PIP): Osilodrostat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000315-PIP02-15-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/08/2019, Last updated: 30/01/2019, Compliance check: Xcortical hyperfunction Oral use Recordati Rare Diseases Tel. +33 1 … -
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Human medicine European public assessment report (EPAR): Cystadrops
mercaptamine hydrochloride, Cystinosis
Date of authorisation: 18/01/2017,
, Revision: 8, Authorised, Last updated: 20/09/2021
Marketing-authorisation holder Recordati Rare Diseases Revision 8 … -
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Opinion/decision on a Paediatric investigation plan (PIP): 6,7-dihydro-5H-pyrrolo[1,2-c] imidazol-5-yl) - (benzo derivative)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000315-PIP01-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 07/09/2009, Last updated: 07/12/2009, Compliance check: Xof hypertension Oral use Recordati Rare Diseases Tel. +33 1 … -
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Human medicine European public assessment report (EPAR): Isturisa
Osilodrostat phosphate, Cushing Syndrome
Date of authorisation: 09/01/2020,
, , Revision: 3, Authorised, Last updated: 17/12/2020
Marketing-authorisation holder Recordati Rare Diseases Revision 3 … -
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Orphan designation: Osilodrostat for: Treatment of Cushing's syndrome
Date of designation: 15/10/2014, Positive, Last updated: 07/07/2020sponsorship was transferred to Recordati Rare Diseases, France in … -
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Orphan designation: propranolol hydrochloride for: Treatment of retinopathy of prematurity
Date of designation: 17/10/2019, Positive, Last updated: 23/01/2020the European Commission to Recordati Rare Diseases, France, for … 17/10/2019 PositiveEU/3/19/2217 Recordati Rare Diseases Immeuble … -
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Human medicine European public assessment report (EPAR): Fortacin
lidocaine, prilocaine, Sexual Dysfunction, Physiological
Date of authorisation: 15/11/2013, Revision: 11, Authorised, Last updated: 20/09/2022PhysiologicalN01BB20 Publication details >Recordati Ireland Ltd.11 15/11/2013 … -
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Orphan designation: pasireotide for: Treatment of acromegaly
Date of designation: 08/10/2009, Positive, Last updated: 13/05/2020sponsorship was transferred to Recordati Rare Diseases, France in … -
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Human medicine European public assessment report (EPAR): Pedea
Ibuprofen, Ductus Arteriosus, Patent
Date of authorisation: 28/07/2004, Revision: 15, Authorised, Last updated: 08/11/2022 -
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Human medicine European public assessment report (EPAR): Silodyx
silodosin, Prostatic Hyperplasia
Date of authorisation: 29/01/2010, Revision: 16, Authorised, Last updated: 10/10/2022 -
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Human medicine European public assessment report (EPAR): Cystagon
mercaptamine bitartrate, Cystinosis
Date of authorisation: 23/06/1997, Revision: 17, Authorised, Last updated: 05/11/2021CYSTA 50 on the body and RECORDATI RARE DISEASES on the cap … -
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Human medicine European public assessment report (EPAR): Cystadane
Betaine anhydrous, Homocystinuria
Date of authorisation: 14/02/2007, Revision: 14, Authorised, Last updated: 23/09/2021 -
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Human medicine European public assessment report (EPAR): Carbaglu
carglumic acid, Amino Acid Metabolism, Inborn Errors; Propionic Acidemia
Date of authorisation: 24/01/2003, Revision: 18, Authorised, Last updated: 09/06/2021 -
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Human medicine European public assessment report (EPAR): Vedrop
tocofersolan, Cholestasis; Vitamin E Deficiency
Date of authorisation: 23/07/2009,, 
, Revision: 13, Authorised, Last updated: 22/08/2019
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Human medicine European public assessment report (EPAR): Wilzin
zinc, Hepatolenticular Degeneration
Date of authorisation: 12/10/2004, Revision: 11, Authorised, Last updated: 14/06/2019 -
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Orphan designation: pasireotide for: Treatment of Cushing's disease
Date of designation: 08/10/2009, Expired, Last updated: 14/06/2022sponsorship was transferred to Recordati Rare Diseases, France in … diseaseExpiredEU/3/09/671 08/10/2009 Recordati Rare Diseases Immeuble … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018
CHMP, Last updated: 16/11/2018Silodosin Recordati … -
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Human medicine European public assessment report (EPAR): Signifor
pasireotide, Acromegaly; Pituitary ACTH Hypersecretion
Date of authorisation: 24/04/2012,, Revision: 14, Authorised, Last updated: 09/08/2022
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Orphan designation: pasireotide for: Treatment of noninsulinoma pancreatogenous hypoglycemia syndrome
Date of designation: 16/05/2022, Positive, Last updated: 14/12/2022syndromePositiveEU/3/22/2620 16/05/2022 Recordati Rare Diseases Immeuble Le … -
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National expert: Beatriz Martinez, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 80.33 KB | PDF
- Curriculum Vitae - 18.45 KB | PDF
Drug Safety Officer Casen Recordati S.L. (Spain) Management … Indication 08/2015-11/2019 Casen Recordati S.L. Cross product responsibility … -
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National expert: Virginie Hivert, European Medicines Agency (updated)
- Declaration of interests - 85.13 KB | PDF
- Curriculum Vitae - 17.04 KB | PDF
company; Orchard Therapeutics; Recordati Rare Diseases; Roche; Swedish … KIRIN; NOVARTIS FARMA S.p.A.; Recordati Rare Diseases; Roche; SANOFI … Switzerland GmbH; Orphalan; Recordati Rare Diseases; Roche; Swedish … -
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National expert: Francois Houyez, European Medicines Agency (updated)
- Declaration of interests - 81.83 KB | PDF
- Curriculum Vitae - 23.46 KB | PDF
company; Orchard Therapeutics; Recordati Rare Diseases; Roche; Swedish … KIRIN; NOVARTIS FARMA S.p.A.; Recordati Rare Diseases; Roche; SANOFI … -
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National expert: Maria Cavaller Bellaubi, European Medicines Agency (updated)
- Declaration of interests - 82.92 KB | PDF
- Curriculum Vitae - 16.18 KB | PDF
Switzerland GmbH; Orphalan; Recordati Rare Diseases; Roche; Swedish … S.p.A.; PTC Therapeutics; Recordati Rare Diseases; Roche; SANOFI …