514 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 … THE 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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Human medicine European public assessment report (EPAR): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 13, Authorised, Last updated: 25/03/2022
Bortezomib Accord Hemostatic Disorders Vascular … Bortezomib Accord … Bortezomib Accord , INN bortezomib 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Bortezomib Hospira
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 12, Authorised, Last updated: 01/03/2022
Bortezomib Hospira Hemostatic Disorders Vascular … Bortezomib Hospira … Bortezomib Hospira, INN bortezomib (as a mannitol boronic ester … -
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Human medicine European public assessment report (EPAR): Bortezomib Sun
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 12, Authorised, Last updated: 09/09/2021
Bortezomib Sun Hemostatic Disorders Vascular … Bortezomib Sun … Bortezomib SUN, INN bortezomib 30 Churchill Place … -
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Opinion/decision on a Paediatric investigation plan (PIP): Velcade, bortezomib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: Bortezomib, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder of solution for injection
Decision date: 14/09/2008, Last updated: 10/10/2008, Compliance check: XBortezomib Oncology … Bortezomib … Word - Decision and Opinion Bortezomib 000233-PIP01-08 for publis… … -
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Human medicine European public assessment report (EPAR): Velcade
bortezomib, Multiple Myeloma
Date of authorisation: 26/04/2004, Revision: 45, Authorised, Last updated: 04/06/2021bortezomib … Velcade bortezomib bortezomib … -
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Withdrawn application: Velcade
bortezomib, date of withdrawal: 02/07/2012, Post-authorisation, Last updated: 30/08/2012authorisation for Velcade (bortezomib) On 2 July 2012, Janssen-Cilag … contains the active substance bortezomib. It has been authorised in … active substance in Velcade, bortezomib, is a proteasome inhibitor … -
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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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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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Press release: European Medicines Agency recommends new contraindication for Velcade (bortezomib)
CHMP, Last updated: 20/03/2008contraindication for Velcade (bortezomib … recommended that Velcade (bortezomib) should not be used in patients … contraindication for Velcade (bortezomib) PDF icon application/pdf … -
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Press release: Janssen-Cilag International NV withdraws its application for an extension of the indication for Velcade (bortezomib)
Last updated: 03/07/2012the indication for Velcade (bortezomib … the indication for Velcade (bortezomib … indication for Velcade (bortezomib) The European Medicines … -
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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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 May 2016
CHMP, Last updated: 27/05/2016matters Adcetris: EPAR Bortezomib Hospira: EPAR Bortezomib Sun: EPAR Epclusa: EPAR Humira … Ninlaro: EPAR Pemetrexed Fresenius Kabi: EPAR Qtern: EPAR Revestive … -
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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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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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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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National expert: Rolf Gedeborg, Medical Products Agency (updated)
- Declaration of interests - 40.34 KB | PDF
- Curriculum Vitae - 44.9 KB | PDF
declared Other comments Fresenius KABI null Son employed as production … production technician at the Fresenius KABI production facility in Uppsala … -
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National expert: Karoline Buhre, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 40.92 KB | PDF
- Curriculum Vitae - 27.93 KB | PDF
declared Other comments Fresenius Kabi null On behalf of ESAIC … two trials sponsored by Fresenius Kabi (PHOENICS and THETYS, both … -
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,
, 
, Revision: 20, Authorised, Last updated: 22/03/2023
and dexamethasone or with bortezomib, melphalan and prednisone … own blood-producing cells). Bortezomib, lenalidomide and melphalan … system; in combination with bortezomib, thalidomide (another medicine … -
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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 …