973 results
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,
, Revision: 5, Authorised, Last updated: 01/09/2021
Bortezomib Fresenius Kabi Hemostatic Disorders Vascular … Bortezomib Fresenius Kabi … MEDICINAL PRODUCT Bortezomib Fresenius Kabi 1 mg powder for solution … -
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 27/07/2022
Pemetrexed Fresenius Kabi Cancer Neoplasms Carcinoma … Pemetrexed Fresenius Kabi … for the public Pemetrexed Fresenius Kabi pemetrexed This is a summary … -
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Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014,, Revision: 9, Authorised, Last updated: 18/05/2021
Busulfan Fresenius Kabi Cancer Neoplasms Stem … Busulfan Fresenius Kabi … Busulfan Fresenius Kabi, inn- Busulfan EMA/195739/2015 … -
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Human medicine European public assessment report (EPAR): Sugammadex Fresenius Kabi
sugammadex sodium, Neuromuscular Blockade
Date of authorisation: 15/07/2022,, Authorised, Last updated: 21/07/2022
Sugammadex Fresenius Kabi Anesthesia and Analgesia Investigative … sugammadex Overview Sugammadex Fresenius Kabi is a medicine used to reverse … the operation. Sugammadex Fresenius Kabi is used to speed up the recovery … -
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of designation: 16/01/2014, Positive, Last updated: 23/01/2014Lactobacillus acidophilus and Bifidobacterium bifidum … Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? Lactobacillus acidophilus and Bifidobacterium bifidum … -
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Human medicine European public assessment report (EPAR): Docetaxel Kabi
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
Docetaxel Kabi Cancer Neoplasms Breast … oduct details Name Docetaxel Kabi Agency product number EMEA/H/C/002325 … Marketing-authorisation holder Fresenius Kabi Deutschland GmbH Revision … -
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Opinion/decision on a Paediatric investigation plan (PIP): 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001354-PIP01-12, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: X2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2 … 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … -
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Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 1, Authorised, Last updated: 26/04/2022Diseases Acid-Base Imbalance Acidosis Acidosis, Renal Tubular … with distal renal tubular acidosis (dRTA), a disease in which … with distal renal tubular acidosis (dRTA), a disease in which … -
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Referral: Ciprofloxacin Kabi
ciprofloxacin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/11/2006, EC decision date: 24/01/2007, Last updated: 06/02/2007Ciprofloxacin Kabi … decision Overview Ciprofloxacine Kabi and associated names, Solution … Gram-positive organisms. Fresenius Kabi Nederland B.V. submitted … -
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Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with medicines for the treatment … require a warning about lactic acidosis. … -
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Referral: Ibuprofen Kabi 400 mg Infusionslösung and associated names
ibuprofen, associated names: Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie, Ibuprofen Fresenius Kabi 400 mg solution pour perfusion, Ibuprofen Kabi, Ibuprofen Kabi 400 mg oldatos infúzió, Ibuprofen Kabi 400 mg soluţie perfuzabilă, Ibuprofen Kabi 400 mg, Ibuprofen Kabi 400 mg raztopina za infundiranje, Ibuprofeno Kabi 400 mg solución para perfusion, Ibuprofen Kabi 400 mg Solution for Infusion, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/07/2020, EC decision date: 15/10/2020, Last updated: 26/10/2020Ibuprofen Kabi 400 mg Infusionslösung and … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014
CHMP, Last updated: 25/07/2014Busulfan Fresenius Kabi … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019
CHMP, Last updated: 20/09/2019Bortezomib Fresenius Kabi … -
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Opinion/decision on a Paediatric investigation plan (PIP): Medium-chain triglycerides, olive oil, Fish oil, Acetyl-cysteine, alanine, histidine, Isoleucin, leucine, Lysine acetate, methionine, phenylalanine, proline, tryptophan, tyrosine, valine, glucose, calcium chloride, potassium chloride, Sodium acetate, Zinc sulfate, Malic acid, arginine, glycine, serine, threonine, sodium glycerophosphate, soya bean oil, magnesium sulfate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Nutrition
PIP number: EMEA-002067-PIP02-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Emulsion for infusion
Decision date: 07/06/2017, Last updated: 24/07/2017, Compliance check: XContact for public enquiries Fresenius Kabi Deutschland GmbH Germany … 61726082294 E-mail: pr-fe@fresenius.com Decision type W: decision … application submitted by Fresenius Kabi Deutschland GmbH on 6 March … -
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Opinion/decision on a Paediatric investigation plan (PIP): N-Acetyl-L-Cysteine (corresponds to L-Cysteine), L-Alanine, L-Alanyl-L-Glutamine (corresponds to L-Alanine and L-Glutamine), L-Arginine, Glycine, Glycyl-L-Tyrosine (corresponds to Glycine and L-Tyrosine), L-Histidine, L-Isoleucine, L-Leucine, L-Lysine acetate (corresponds to L-Lysine), LMethionine, L-Phenylalanine, L-Proline, L-Serine, Taurine, L-Threonine, L-Tryptophan, L-Valine
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Nutrition
PIP number: EMEA-000042-PIP01-07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 07/09/2009, Last updated: 22/10/2009, Compliance check: Xrequired. Intravenous use Fresenius Kabi Deutschland GmbH E-mail … Deutschland GmbH E-mail: pr-fre@fresenius.com Country: Germany Phone … month. As agreed earlier, Fresenius Kabi would have to apply for a … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016
CHMP, Last updated: 27/05/2016Pemetrexed Fresenius Kabi … -
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Human medicine European public assessment report (EPAR): Kromeya
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Psoriasis; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Colitis, Ulcerative; Crohn Disease
Date of authorisation: 02/04/2019,
, 
, Revision: 4, Withdrawn, Last updated: 25/03/2020
Marketing-authorisation holder Fresenius Kabi Deutschland GmbH Revision … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 May 2022
CHMP, Last updated: 20/05/2022Sugammadex Fresenius Kabi … -
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National expert: Henrik Bengtsson, Medical Products Agency (updated)
- Declaration of interests - 80.53 KB | PDF
- Curriculum Vitae - 16.95 KB | PDF
2014-June 2021 Design responsible Fresenius Kabi AB (Sweden) Quality expert … 2012-April 2014 Release officer Fresenius Kabi AB (Sweden) Quality assurance … Indication 09/2010-06/2021 Fresenius Kabi AB Individual product responsibility … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 March 2012
CHMP, Last updated: 16/03/2012application/pdf Docetaxel Kabi docetaxel Fresenius Kabi Oncology Plc zoledronic acid … -
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National expert: Rolf Gedeborg, Medical Products Agency (updated)
- Declaration of interests - 80.21 KB | PDF
- Curriculum Vitae - 30.46 KB | PDF
Type of Interest Declared Fresenius KABI Son employed as production … production technician at the Fresenius KABI production facility in Uppsala … -
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National expert: Loreto Carmona, European Medicines Agency (updated)
- Declaration of interests - 81.42 KB | PDF
- Curriculum Vitae - 108.52 KB | PDF
Iberia, Eisai Farmacéutica, Fresenius Kabi España, Laboratorios Gebro … 06/2021-(current) Amgen, Fresenius Kabi, Galápagos, Lilly, MSD … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 26-28 June 2006
CHMP, Last updated: 29/06/2006hydrogen sulphate), from Fresenius Kabi. The procedure was initiated … medicinal product Ciprofloxacine Kabi (ciprofloxacin hydrogen sulphate … hydrogen sulphate), from Fresenius Kabi. The procedure was initiated … -
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National expert: Karoline Buhre, Federal Institute For Drugs And Medical Devices (updated)
- Declaration of interests - 80.38 KB | PDF
- Curriculum Vitae - 0 bytes | PDF
Type of Interest Declared Fresenius Kabi On behalf of ESAIC (European … of two trials sponsored by Fresenius Kabi (PHOENICS and THETYS, both … -
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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 …