7184 results
Keyword Pemetrexed EG Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): EGFR-cMET bispecific antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002573-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: XActive substance EGFR-cMET bispecific antibody Therapeutic … EGFR-cMET bispecific antibody … -
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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -
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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously Pemetrexed Hospira)
pemetrexed disodium, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 19/11/2015,
, Revision: 14, Authorised, Last updated: 21/09/2022
Pemetrexed Pfizer (previously Pemetrexed Hospira) Cancer Neoplasms Carcinoma … Pemetrexed Pfizer (previously Pemetrexed Hospira … summary for the public Pemetrexed Hospira pemetrexed This is a summary of the … -
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Human medicine European public assessment report (EPAR): Arepanrix
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 23/03/2010,
, Revision: 1, Withdrawn, Last updated: 25/10/2011
strain (X-179A)*propagated in eggs.pandemic influenza vaccine (H1N1)v … in the vaccine, such as egg or chicken protein, ovalbumin … protein, ovalbumin (a protein in egg white), formaldehyde and … -
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Human medicine European public assessment report (EPAR): Humenza
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 08/06/2010,, Withdrawn, Last updated: 30/06/2011
strain (X-179A)*propagated in eggs.pandemic influenza vaccine (H1N1 … as ovalbumin (a protein in egg white egg or chicken proteins, neomycin … strain (X-179A)*propagated in eggs. … -
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Human medicine European public assessment report (EPAR): Pemetrexed medac
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 26/11/2015,, Revision: 8, Authorised, Last updated: 09/08/2022
Pemetrexed medac Cancer Neoplasms Carcinoma … Pemetrexed medac … Pemetrexed medac, INN pemetrexed 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Pemetrexed Lilly
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 14/09/2015,, Revision: 7, Withdrawn, Last updated: 26/11/2021
Pemetrexed Lilly Cancer Neoplasms Carcinoma … Pemetrexed Lilly … EMEA/H/C/004114 Public statement Pemetrexed Lilly Cessation of validity … -
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Human medicine European public assessment report (EPAR): Pemetrexed Krka
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 6, Authorised, Last updated: 22/02/2023
Pemetrexed Krka Cancer Neoplasms Carcinoma … Pemetrexed Krka … Pemetrexed Krka, INN pemetrexed 30 Churchill Place … -
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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 … summary for the public Pemetrexed Fresenius Kabi pemetrexed This is a summary of the … -
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
Pemetrexed Baxter Carcinoma, Bronchogenic Bronchial … Pemetrexed Baxter … EMA/841935/2022 EMEA/H/C/005848 Pemetrexed Baxter pemetrexed) An overview of Pemetrexed Baxter and why it is authorised … -
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Human medicine European public assessment report (EPAR): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 9, Authorised, Last updated: 03/11/2022
Pemetrexed Accord Carcinoma, Bronchogenic Bronchial … Pemetrexed Accord … Pemetrexed Accord, INN pemetrexed EMA/783154/2015 EMEA/H/C/004072 … -
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Human medicine European public assessment report (EPAR): Pemetrexed Sandoz
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/09/2015,, Revision: 7, Authorised, Last updated: 27/07/2022
Pemetrexed Sandoz Carcinoma, Bronchogenic Bronchial … Pemetrexed Sandoz … summary for the public Pemetrexed Sandoz pemetrexed This is a summary of the … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 24/04/2017,, Revision: 7, Withdrawn, Last updated: 29/07/2021
Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited) Carcinoma … Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited … EMEA/H/C/004488 Public statement Pemetrexed Pfizer Cessation of validity … -
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Withdrawn application: Pemetrexed ditromethamine Hospira
pemetrexed, date of withdrawal: 22/09/2016, Initial authorisation, Last updated: 21/12/2016Pemetrexed ditromethamine Hospira: Withdrawn … Pemetrexed ditromethamine Hospira; INN pemetrexed (as ditromethamine … authorisation application for Pemetrexed (as ditromethamine) Hospira … -
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Human medicine European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis)
pemetrexed diacid monohydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016, Revision: 12, Authorised, Last updated: 18/01/2023Armisarte (previously Pemetrexed Actavis) Cancer Neoplasms Carcinoma … Armisarte (previously Pemetrexed Actavis … the public Armisarte1 pemetrexed This is a summary of the … -
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Human medicine European public assessment report (EPAR): Alimta
pemetrexed, Mesothelioma; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/09/2004, Revision: 27, Authorised, Last updated: 03/05/2022pemetrexed … for the public Alimta pemetrexed This is a summary of the … contains the active substance pemetrexed. What is Alimta used for … -
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Human medicine European public assessment report (EPAR): Ciambra
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 02/12/2015,, Revision: 6, Authorised, Last updated: 17/08/2022
pemetrexed … for the public Ciambra pemetrexed This is a summary of the … contains the active substance pemetrexed. http://www.ema.europa.eu/do … -
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Opinion/decision on a Paediatric investigation plan (PIP): Alimta, pemetrexed disodium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000126-PIP01-07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 24/02/2009, Last updated: 23/04/2009, Compliance check: Xname Alimta Active substance pemetrexed disodium Therapeutic area … product-specific waiver for pemetrexed disodium (Alimta) (EMEA-000126-PIP01-07 … product specific waiver for pemetrexed disodium (Alimta) (EMEA-000126-PIP01-07 … -
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Orphan designation: Refusal of orphan designation for the treatment of poisoning by local anaesthetics
Date of refusal of designation: 03/04/2017, Negative, Last updated: 15/05/2017of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … -
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Orphan designation: pemetrexed disodium for: Treatment of malignant mesothelioma
Date of designation: 17/09/2001, Withdrawn, Last updated: 06/05/2011pemetrexed disodium … smop¯R¯pemetrexed disodium¯EMEA-COMP-1294-03 … opinion on orphan designation Pemetrexed disodium for the treatment … -
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Human medicine European public assessment report (EPAR): Daronrix
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 21/03/2007,
, Withdrawn, Last updated: 02/07/2013
A/Vietnam/1194/2004 (H5N1)* produced in eggspandemic influenza vaccine (whole … in the vaccine, such as eggs, chicken protein or gentamicin … A/Vietnam/1194/2004 (H5N1)* produced in eggs … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000669-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 04/01/2019, Last updated: 21/09/2021, Compliance check: V, 26/04/2019strain (X-179A)*propagated in eggs. … -
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Opinion/decision on a Paediatric investigation plan (PIP): Arepanrix, Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000687-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for emulsion for injection
Decision date: 09/08/2010, Last updated: 07/10/2010, Compliance check: V, 12/12/2014strain (X-179A)*propagated in eggs. … -
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National expert: zuzana egyud, Institute For State Control Of Veterinary Biologicals And Medicaments (updated)
- Declaration of interests - 39.5 KB | PDF
- Curriculum Vitae - 22.07 KB | PDF
zuzana egyud … zuzana egyud … Vitae Personal information zuzana egyud Work experience …