136 results
Keyword Oxaliplatino Kabi Remove keyword
-
List item
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 Head and Neck Neoplasms Carcinoma … Docetaxel Kabi … authorisation) Docetaxel Kabi docetaxel On 15 March … -
List item
Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi (updated)
pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 10, Authorised, Last updated: 10/02/2021
Pemetrexed Fresenius Kabi Carcinoma, Non-Small-Cell … Pemetrexed Fresenius Kabi … public Pemetrexed Fresenius Kabi pemetrexed This is a summary … -
List item
Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 3, Authorised, Last updated: 18/01/2021
Bortezomib Fresenius Kabi Multiple Myeloma … Overview Bortezomib Fresenius Kabi is a medicine used to treat … patients, Bortezomib Fresenius Kabi is used in combination with … -
List item
Human medicine European public assessment report (EPAR): Busulfan Fresenius Kabi
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 22/09/2014,, Revision: 8, Authorised, Last updated: 15/01/2021
Busulfan Fresenius Kabi Hematopoietic Stem Cell … EPAR) for Busulfan Fresenius Kabi. It explains how the Agency … to use Busulfan Fresenius Kabi. For practical information … -
List item
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 … Ciprofloxacin Kabi … round Summary Ciprofloxacine Kabi Art 29 European … -
List item
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 … Ibuprofen Kabi 400 mg Infusionslösung and … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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: Xpublic enquiries Fresenius Kabi Deutschland GmbH E-mail … agreed earlier, Fresenius Kabi would have to apply for a … -
List item
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 … -
List item
Press release: PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel
PRAC, Last updated: 09/06/2017taxel Accord: EPAR Docetaxel Kabi: EPAR Docetaxel Teva: EPAR … -
List item
Human medicine European public assessment report (EPAR): Idacio
adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease
Date of authorisation: 02/04/2019,, , Revision: 5, Authorised, Last updated: 18/12/2020
Marketing-authorisation holder Fresenius Kabi Deutschland GmbH Revision … -
List item
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 … -
List item
National expert: Daniel Brasseur, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 79.74 KB | PDF
- Curriculum Vitae - 17.72 KB | PDF
Medical Director Benelux Kabi-Pharmacia (Belgium) Part-time Management … -
List item
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 … -
List item
National expert: Marjo-Riitta Helle, Finnish Medicines Agency (updated)
- Declaration of interests - 79.87 KB | PDF
- Curriculum Vitae - 17.69 KB | PDF
1986-August 1987 Qualified Person KabiVitrum AB (Sweden) Parenteral production June … facts Former employment at KabiVitrum Ab Sweden 1986-87 and Leiras … -
List item
National expert: Elin Blom, Medical Products Agency (updated)
- Declaration of interests - 80.27 KB | PDF
- Curriculum Vitae - 18.49 KB | PDF
Affairs Manager Fresenius Kabi AB (Sweden) Regulatory Affairs … Indication 01/2013-07/2018 Fresenius Kabi AB (Sweden) Cross product … -
List item
National expert: Anna Joo, Medical Products Agency (updated)
- Declaration of interests - 80.02 KB | PDF
- Curriculum Vitae - 16.37 KB | PDF
Interest Declared Fresenius Kabi Working as Quality Assurance … -
List item
National expert: Lina Pave, Medical Products Agency (updated)
- Declaration of interests - 80.02 KB | PDF
- Curriculum Vitae - 16.42 KB | PDF
Interest Declared Fresenius Kabi AB, Sweden employment 2.9 … -
List item
National expert: Ernst A. Singer, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 80.17 KB | PDF
- Curriculum Vitae - 16.67 KB | PDF
Interest Declared Fresenius Kabi Spouse holds leading position … -
List item
National expert: Kerstin Elisabeth Sollerbrant Melefors, European Medicines Agency (updated)
- Declaration of interests - 80.07 KB | PDF
- Curriculum Vitae - 24.31 KB | PDF
1991 Laboratory engineer Kabi Pharmacia KabiGen) (Sweden) Research and development … -
List item
National expert: Niclas Falk, Medical Products Agency (updated)
- Declaration of interests - 79.74 KB | PDF
- Curriculum Vitae - 16.27 KB | PDF
affairs manager Fresenius Kabi (Sweden) February 2010-November …