7155 results
Keyword Abiraterone 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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess … -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): Abiraterone Accord
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021,
, Authorised, Last updated: 05/05/2021
Abiraterone Accord Cancer Neoplasms Genital … Abiraterone Accord … EMA/163793/2021 EMEA/H/C/005408 Abiraterone Accord abiraterone acetate) An overview of Abiraterone Accord and why it is authorised … -
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Human medicine European public assessment report (EPAR): Abiraterone Krka
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 2, Authorised, Last updated: 08/03/2023
Abiraterone Krka Genital Neoplasms … Abiraterone Krka … EMA/258413/2021 EMEA/H/C/005649 Abiraterone Krka abiraterone acetate) An overview of Abiraterone Krka and why it is authorised … -
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Human medicine European public assessment report (EPAR): Abiraterone Mylan
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 17/03/2023
Abiraterone Mylan Cancer Neoplasms Genital … Authorised abiraterone acetate Overview Abiraterone Mylan is a cancer medicine … of the body (metastatic). Abiraterone Mylan is used together with … -
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 26, Authorised, Last updated: 06/12/2022
abiraterone … Zytiga, INN-abiraterone acetate 30 Churchill … for the public Zytiga abiraterone acetate This is a summary … -
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Summary of opinion: Akeega
niraparib, abiraterone acetate, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023niraparib abiraterone acetate Opinion On 23 February … authorisation) Akeega niraparib / abiraterone acetate On 23 February … 50 mg niraparib / 500 mg abiraterone acetate or 100 mg niraparib … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Niraparib (tosilate monohydrate), abiraterone acetate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002789-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/07/2021, Last updated: 21/06/2021, Compliance check: XNiraparib (tosilate monohydrate) abiraterone acetate OncologyP/0244/2020EMEA-002789-PIP01-20 … tosylate monohydrate) / abiraterone (acetate) (EMEA-002789-PIP01-20 … tosylate monohydrate) / abiraterone (acetate) (EMEA-002789-PIP01-20 … -
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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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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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Abiraterone acetate product-specific bioequivalence guidance
Last updated: 23/11/2020Abiraterone acetate product-specific … conditions. bioequivalence of abiraterone acetate … Products for Human Use (CHMP) Abiraterone acetate tablets 250 mg and …
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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 … -
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National expert: Egle Sulioke, European Medicines Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 23.43 KB | PDF
Egle Sulioke … Egle Sulioke … Vitae Personal information Egle Sulioke Work experience … -
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National expert: Egberdina Botjes, European Medicines Agency (updated)
- Declaration of interests - 39.35 KB | PDF
- Curriculum Vitae - 21.58 KB | PDF
Egberdina Botjes … Egberdina Botjes … Vitae Personal information Egberdina Botjes Work experience … -
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National expert: Egle Audova, State Agency of Medicines (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 22.59 KB | PDF
Egle Audova … Egle Audova … Vitae Personal information Egle Audova Work experience … -
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National expert: Iveta Eglite, State Agency of Medicines (updated)
- Declaration of interests - 39.29 KB | PDF
- Curriculum Vitae - 23.56 KB | PDF
Iveta Eglite … Iveta Eglite … Vitae Personal information Iveta Eglite Work experience … -
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National expert: Egle Daniuleviciute, State Medicines Control Agency (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 27.49 KB | PDF
Egle Daniuleviciute … Egle Daniuleviciute … Vitae Personal information Egle Daniuleviciute Work experience … -
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National expert: Egbert Flory, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 39.63 KB | PDF
- Curriculum Vitae - 32.52 KB | PDF
Egbert Flory … Egbert Flory … Vitae Personal information Egbert Flory Work experience … -
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National expert: Susanne Mueller-Egert, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 39.38 KB | PDF
- Curriculum Vitae - 24.03 KB | PDF
Susanne Mueller-Egert … Susanne Mueller-Egert … information Susanne Mueller-Egert Work experience … -
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National expert: Bjoern Egil Olsen, Norwegian Medicines Agency (updated)
- Declaration of interests - 39.34 KB | PDF
- Curriculum Vitae - 23.15 KB | PDF
Bjoern Egil Olsen … Bjoern Egil Olsen … Vitae Personal information Bjoern Egil Olsen Work experience …