9940 results
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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): 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): 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 … 26/04/2021 Busulfan Fresenius Kabi - EMEA/H/C/002806 - IB/0020 … product characteristics Annex IIA - Manufacturing-authorisation … -
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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): 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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Orphan designation: Pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein for: Treatment of glioma
Date of designation: 30/04/2002, Withdrawn, Last updated: 20/10/2016Pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein Overview … pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein [hIL13-PE-38QQR … pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein for the … -
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Orphan designation: Autologous collagen type II-specific regulatory T cells for: Treatment of non-infectious uveitis
Date of designation: 16/12/2014, Withdrawn, Last updated: 19/11/2019Autologous collagen type II-specific regulatory T cells Overview … Autologous collagen type II-specific regulatory T cells … -
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Veterinary medicine European public assessment report (EPAR): Forceris
toltrazuril, iron (III) ion, Pigs (piglets)
Date of authorisation: 23/04/2019, Revision: 1, Authorised, Last updated: 04/04/2022Authorised toltrazuriliron (III) ion Overview Forceris is … Toltrazuril 30.0 mg Iron (III) 133.4 mg (as gleptoferron … Forceris toltrazuril iron (III) ion iron III) ion … -
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Veterinary medicine European public assessment report (EPAR): Baycox Iron
Iron(iii) ion, toltrazuril, Pigs (piglets)
Date of authorisation: 20/05/2019, Authorised, Last updated: 07/04/2020Authorised toltrazuriliron (III) ion Overview Baycox Iron … Toltrazuril 36.4 mg Iron (III) 182 mg (as gleptoferron … Iron toltrazuril iron (III) ion Iron iii) ion … -
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Human medicine European public assessment report (EPAR): Giapreza (updated)
Angiotensin II acetate, Hypotension; Shock
Date of authorisation: 23/08/2019,
, Revision: 3, Authorised, Last updated: 24/03/2023
Authorised angiotensin II Overview Giapreza is a medicine … active substance angiotensin II. How is Giapreza used? The … in Giapreza, angiotensin II, is the same as a hormone … -
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Orphan designation: HLA class I/II binding tumour associated peptides (ADF-APO-CCN-GUC-K67-MET-MMP-MUC-RGS) for: Treatment of renal-cell carcinoma
Date of designation: 15/02/2007, Withdrawn, Last updated: 20/10/2016HLA class I/II binding tumour associated … GmbH, Germany, for HLA class I/II binding tumour associated … cell carcinoma. HLA class I/II binding tumour associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001912-PIP02-16-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 15/04/2019, Last updated: 30/06/2021, Compliance check: XKey facts Angiotensin II (LJPC-501) Cardiovascular … investigation plan for angiotensin II (LJPC-501) (EMEA-001912-PIP02-16-M02 … Angiotensin II (LJPC-501 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501)
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Other
PIP number: EMEA-001912-PIP01-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 26/09/2016, Last updated: 27/10/2016, Compliance check: XKey facts Angiotensin II (LJPC-501) OtherP/0253/2016EMEA-001912-PIP01-15 … deferral for angiotensin II (LJPC-501) (EMEA-001912-PIP01-15 … deferral for angiotensin II (LJPC-501) (EMEA-001912-PIP01-15) 30 … -
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Orphan designation: 18-(p-(131I)-iodophenyl)octadecyl phosphocholine for: Treatment of multiple myeloma
Date of designation: 17/10/2019, Positive, Last updated: 11/05/202118-(p-(131I)-iodophenyl)octadecyl phosphocholine Overview On … S.A.R.L., France, for 18-(p-(131I)-iodophenyl)octadecyl phosphocholine (also known … designation of 18-(p-(131I)-Iodophenyl)octadecyl phosphocholine for the treatment … -
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Orphan designation: Recombinant human soluble Fc-gamma receptor II b for: Treatment of idiopathic thrombocytopenic purpura
Date of designation: 02/08/2007, Withdrawn, Last updated: 16/10/2019soluble Fc-gamma receptor II b Overview Please note that … soluble Fc-gamma receptor II b for the treatment of idiopathic … soluble Fc-gamma receptor II b could be of potential significant … -
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Orphan designation: 18-(p-[131I]-iodophenyl)octadecyl phosphocholine for: Treatment of lymphoplasmacytic lymphoma
Date of designation: 19/02/2021, Positive, Last updated: 22/02/202218-(p-[131I]-iodophenyl)octadecyl phosphocholine Overview This … 18-(p-[131I]-iodophenyl)octadecyl phosphocholine … -
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Opinion/decision on a Paediatric investigation plan (PIP): 18-(p-[131I]-iodophenyl)octadecyl phosphocholine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002745-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 13/05/2020, Last updated: 05/03/2021, Compliance check: XKey facts 18-(p-[131I]-iodophenyl)octadecyl phosphocholine OncologyP/0169/2020EMEA-002745-PIP01-19 … specific waiver for 18-(p-[131I]-iodophenyl)octadecyl phosphocholine (EMEA-002745-PIP01-19 … specific waiver for 18-(p-[131I]-iodophenyl)octadecyl phosphocholine (EMEA-002745-PIP01-19 … -
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Opinion/decision on a Paediatric investigation plan (PIP): 18-(p-[131I]-iodophenyl)octadecyl phosphocholine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002745-PIP02-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/01/2021, Last updated: 29/09/2021, Compliance check: XKey facts 18-(p-[131I]-iodophenyl)octadecyl phosphocholine OncologyP/0011/2021EMEA-002745-PIP02-20 … specific waiver for 18-(p-[131I]-iodophenyl)octadecyl phosphocholine (EMEA-002745-PIP02-20 … specific waiver for 18-(p-[131I]-iodophenyl)octadecyl phosphocholine (EMEA-002745-PIP02-20 … -
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Orphan designation: Recombinant human monoclonal antibody against activin receptor type IIB for: Treatment of inclusion body myositis
Date of designation: 09/08/2012, Withdrawn, Last updated: 24/10/2018against activin receptor type IIB Overview … against activin receptor type IIB … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human antibody against activin type IIB receptors
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001286-PIP01-12, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for injection
Decision date: 24/08/2012, Last updated: 18/09/2012, Compliance check: Xantibody against activin type IIB receptors NeurologyP/0201/2012EMEA-001286-PIP01-12 … antibody against activin type IIB receptors (EMEA-001286-PIP01-12 … antibody against activin type IIB receptors (EMEA-001286-PIP01-12 … -
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Orphan designation: [5,10,15,20-tetrakis(4-carboxyphenyl)-21H,23H-porphine]manganese(III) chloride for: Treatment of Cockayne syndrome
Date of designation: 12/01/2017, Positive, Last updated: 13/07/20175,10,15,20-тетракис(4-карбоксифенил)-21H,23H- порфин]манганов(III) хлорид Лечение … 5,10,15,20-tetrakis(4-karboksifenil)-21H,23H- porfin]mangan(III) klorid Liječenje sindroma … 5,10,15,20-tetrakis(4-karboxyfenyl)-21H,23H- porfin]mangan(III) chlorid Léčba Cockaynova … -
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Orphan designation: Recombinant fusion protein consisting of the extracellular portion of human activin receptor IIB linked to the human IgG1 Fc domain for: Treatment of Duchenne muscular dystrophy
Date of designation: 26/11/2010, Withdrawn, Last updated: 06/03/2015of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 … the 'activin receptor type IIB'; a part of a human antibody … -
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Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of beta thalassaemia intermedia and major (updated)
Date of designation: 29/07/2014, Positive, Last updated: 21/03/2023of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 … -
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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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Orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain (luspatercept) for: Treatment of myelodysplastic syndromes
Date of designation: 22/08/2014, Positive, Last updated: 18/02/2021of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 … of human activin receptor IIB linked to the human IgG1 …