983 results
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Human medicine European public assessment report (EPAR): Stimufend
pegfilgrastim, Neutropenia
Date of authorisation: 28/03/2022,
, 
, Authorised, Last updated: 04/04/2022
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Human medicine European public assessment report (EPAR): Bondenza (previously Ibandronic Acid Roche)
ibandronic acid, Osteoporosis, Postmenopausal
Date of authorisation: 23/02/2004, Revision: 16, Withdrawn, Last updated: 13/05/2013Roche)EMEA/H/C/000502ibandronic acidibandronic acidOsteoporosis, PostmenopausalM05BA06 Publication … -
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Human medicine European public assessment report (EPAR): Idacio
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid
Date of authorisation: 02/04/2019,, , Revision: 10, Authorised, Last updated: 18/10/2022
Marketing-authorisation holder Fresenius Kabi Deutschland GmbH Revision … -
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National expert: Michal Rataj, European Medicines Agency (updated)
- Declaration of interests - 46.23 KB | PDF
- Curriculum Vitae - 24.12 KB | PDF
Europe €20,000 for 2021 work plan Fresenius Kabi €5,000 for STYPA Grunenthal … Europe €20,000 for 2021 work plan Fresenius Kabi €5,000 for STYPA Grunenthal … -
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National expert: Therese Jonsson, Medical Products Agency (updated)
- Declaration of interests - 40.08 KB | PDF
- Curriculum Vitae - 23.14 KB | PDF
Country: Sweden 2. Employer: Fresenius Kabi • Start date: 012010 • … indication Past 01-01- 2010 01-10- 2021 Fresenius Kabi AB null Formulation scientist … -
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National expert: Loreto Carmona, European Medicines Agency (updated)
- Declaration of interests - 41.99 KB | PDF
- Curriculum Vitae - 79.7 KB | PDF
re Current 01-06- 2021 22-03- 2023 Amgen, Fresenius Kabi, Galápagos, Lilly, MSD … -
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National expert: Erwin Dreesen, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 42.36 KB | PDF
- Curriculum Vitae - 177.82 KB | PDF
Biocodex, Dr. Falk Pharma, Fresenius Kabi, Ipsen, Menarini, Microbiotica … -
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National expert: Niclas Falk, Medical Products Agency (updated)
- Declaration of interests - 39.34 KB | PDF
- Curriculum Vitae - 22.91 KB | PDF
Country: Sweden 1. Employer: Fresenius Kabi • Start date: 112010 • … -
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National expert: Javad Mohammadnejad, Medical Products Agency (updated)
- Declaration of interests - 39.46 KB | PDF
- Curriculum Vitae - 23.79 KB | PDF
Country: Sweden 2. Employer: Fresenius Kabi AB • Start date: 122002 • … -
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National expert: Ola Martinelle, Medical Products Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 40.05 KB | PDF
syringes. • 1995-11 – 1999-05 Fresenius Kabi / Pharmacia & Upjohn, Sweden QA … -
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National expert: Virve Reiman-Suijkerbuijk, Medical Products Agency (updated)
- Declaration of interests - 39.59 KB | PDF
- Curriculum Vitae - 27.13 KB | PDF
Country: Sweden 5. Employer: Fresenius Kabi AB • Start date: 011998 • … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
CHMP, Last updated: 24/07/2020Ibuprofen Kabi 400 mg Infusionslösung and … Marketing-authorisation holder Fresenius Kabi Deutschland GmbH More information … More information Ibuprofen Kabi 400 mg Infusionslösung and … -
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National expert: Elin Blom, Medical Products Agency (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 35.97 KB | PDF
Country: Sweden 2. Employer: Fresenius Kabi AB • Start date: 012013 • … -
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National expert: Audrey Sultana, Medicines Authority (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 26.68 KB | PDF
Authorisation Application Busulfan Fresenius Kabi –Marketing Authorisation … -
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National expert: Katrin Féchir, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 39.29 KB | PDF
- Curriculum Vitae - 26.29 KB | PDF
Country: Germany 1. Employer: Fresenius Kabi • Start date: 082008 • … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021treatment of distal renal tubular acidosis … treatment of distal renal tubular acidosis On 20 June 2017, orphan … treatment of distal renal tubular acidosis. What is distal renal tubular … -
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National expert: Kai-Uwe Riedel, Medical Products Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 28.05 KB | PDF
Country: Sweden 3. Employer: Fresenius Kabi • Start date: 102000 • … -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 10/08/2015, Positive, Last updated: 27/03/2023encephalomyopathy, lactic acidosis and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … -
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Orphan designation: Vatiquinone for: Treatment of mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes
Date of designation: 24/02/2022, Positive, Last updated: 28/04/2022encephalomyopathy, lactic acidosis, and stroke-like episodes … -
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Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 21/08/2020, Positive, Last updated: 25/11/2020encephalomyopathy, lactic acidosis and stroke-like episodes … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Pharma
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/08/2012,
, Revision: 11, Withdrawn, Last updated: 12/12/2018
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Generics
zoledronic acid monohydrate, Osteoporosis; Osteitis Deformans
Date of authorisation: 27/03/2014,, Revision: 2, Withdrawn, Last updated: 08/08/2016
acid monohydratezoledronic acidOsteoporosisOsteitis DeformansM05BA08 This is … -
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Orphan designation: 2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 12/12/2017, Positive, Last updated: 03/02/2021encephalomyopathy, lactic acidosis and stroke-like episodes … encephalomyopathy, lactic acidosis and stroke-like episodes … encephalomyopathy, lactic acidosis and stroke-like episodes … -
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Human medicine European public assessment report (EPAR): Ebymect (updated)
dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2015, Revision: 19, Authorised, Last updated: 30/05/2023any form of acute metabolic acidosis (build up of acid in the … called ketones) or lactic acidosis (build-up of lactic acid … increase the risk of lactic acidosis (see section 4.4) should … -
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Human medicine European public assessment report (EPAR): Xigduo (updated)
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 21, Authorised, Last updated: 30/05/2023any form of acute metabolic acidosis (build up of acid in the … ‘ketones’) or lactic acidosis (build-up of lactic acid …