185 results
Keyword Adenosina Kabi Remove keyword
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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 … Docetaxel Kabi … authorisation) Docetaxel Kabi docetaxel On 15 March … -
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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 … 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): 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 … Overview Bortezomib Fresenius Kabi is a medicine used to treat … patients, Bortezomib Fresenius Kabi is used in combination with … -
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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 … Overview Sugammadex Fresenius Kabi is a medicine used to reverse … operation. Sugammadex Fresenius Kabi is used to speed up the recovery … -
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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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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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Summary of opinion: Tyenne
tocilizumab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023medicinal product is Fresenius Kabi Deutschland GmbH. Tyenne … medicinal product is Fresenius Kabi Deutschland GmbH. Tyenne … -
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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,
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, 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) 21-24 July 2014
CHMP, Last updated: 25/07/2014Busulfan Fresenius Kabi … -
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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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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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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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Press release: PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel
PRAC, Last updated: 09/06/2017Docetaxel Accord: EPAR Docetaxel Kabi: EPAR Docetaxel Teva: EPAR … -
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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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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 26-28 June 2006
CHMP, Last updated: 29/06/2006Ciprofloxacine Kabi … medicinal product Ciprofloxacine Kabi (ciprofloxacin hydrogen sulphate … sulphate), from Fresenius Kabi. The procedure was initiated … -
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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: Xpublic enquiries Fresenius Kabi Deutschland GmbH Germany … application submitted by Fresenius Kabi Deutschland GmbH on 6 March … is addressed to Fresenius Kabi Deutchland GmbH, Else-Kröner-Strasse … -
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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: XIntravenous use Fresenius Kabi Deutschland GmbH E-mail … 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) 16-19 May 2022
CHMP, Last updated: 20/05/2022Sugammadex Fresenius Kabi … -
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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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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: Henrik Bengtsson, Medical Products Agency (updated)
- Declaration of interests - 40.2 KB | PDF
- Curriculum Vitae - 23.64 KB | PDF
Sweden 1. Employer: Fresenius Kabi AB • Start date: 042014 • … Sweden 2. Employer: Fresenius Kabi AB • Start date: 102012 • … Sweden 3. Employer: Fersenius Kabi AB • Start date: 052010 • … -
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National expert: Karoline Buhre, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 40.27 KB | PDF
- Curriculum Vitae - 25.16 KB | PDF
declared Other comments Fresenius Kabi null On behalf of ESAIC … trials sponsored by Fresenius Kabi (PHOENICS and THETYS, both … -
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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
Dr. Falk Pharma, Fresenius Kabi, Ipsen, Menarini, Microbiotica … -
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National expert: Rolf Gedeborg, Medical Products Agency (updated)
- Declaration of interests - 39.89 KB | PDF
- Curriculum Vitae - 46.87 KB | PDF
declared Other comments Fresenius KABI null Son employed as production … technician at the Fresenius KABI production facility in Uppsala …