7187 results
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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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess … -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): 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, Revision: 1, Withdrawn, Last updated: 25/10/2011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Date of authorisation: 08/06/2010,, Withdrawn, Last updated: 30/06/2011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): Nustendi
Bempedoic acid, Ezetimibe, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 27/03/2020,
, Revision: 5, Authorised, Last updated: 21/04/2022
substances bempedoic acid and ezetimibe. Nustendi is used in combination … statin taken together with ezetimibe. Nustendi can also be used … are not lowered enough by ezetimibe. The medicine can be used … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001447-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: XKey facts Ezetimibe Rosuvastatin Cardiovascular … cardiovascular disease Oral use EGIS Pharmaceuticals PLC Hungary … Pharmaceuticals PLC Hungary registry@egis.hu Tel. +361 18032414 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001447-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 28/05/2013, Last updated: 24/06/2013, Compliance check: XKey facts Rosuvastatin Ezetimibe Cardiovascular diseasesP/0131/2013EMEA-001447-PIP01-12 … elevated cholesterol Oral use EGIS Pharmaceuticals PLC Hungary … Pharmaceuticals PLC Hungary registry@egis.hu Tel. +361 18032414 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001278-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Tablet
Decision date: 20/08/2012, Last updated: 17/09/2012, Compliance check: XActive substance Rosuvastatin Ezetimibe Therapeutic area Cardiovascular … Contact for public enquiries EGIS Pharmaceuticals PLC Country … Hungary E-mail: registry@egis.hu Tel. +36 1803 2414 Fax … -
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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): Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000007-PIP04-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/07/2012, Last updated: 22/08/2012, Compliance check: Xassociated names Active substance Ezetimibe Therapeutic area Cardiovascular … product specific waiver for ezetimibe (Ezetrol and associated names … product specific waiver for ezetimibe (Ezetrol and associated names … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000007-PIP01-07-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 28/03/2012, Last updated: 20/04/2012, Compliance check: V, 17/01/2013associated names Active substance Ezetimibe Therapeutic area Cardiovascular … paediatric investigation plan for Ezetimibe (Ezetrol and associated names … paediatric investigation plan for Ezetimibe (Ezetrol and associated … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Ezetimibe and simvastatin (fixed combination), Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 14/09/2008, Last updated: 10/10/2008, Compliance check: XEzetimibe and simvastatin (fixed combin … Ezetimibe and simvastatin (fixed combin … Word - Decision and Opinion Ezetimibe and simvastatin 000006-PIP0… … -
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Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002207-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: XActive substance atorvastatin Ezetimibe Therapeutic area Cardiovascular … waiver for atorvastatin / ezetimibe (EMEA-002207-PIP01-17 … waiver for atorvastatin / ezetimibe (EMEA-002207-PIP01-17) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000006-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/04/2011, Last updated: 12/05/2011, Compliance check: Xassociated names Active substance Ezetimibe simvastatin Therapeutic area … product specific waiver for ezetimibe/simvastatin (Inegy and associated names … product specific waiver for ezetimibe/simvastatin (Inegy and associated names … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000006-PIP03-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 23/07/2012, Last updated: 22/08/2012, Compliance check: Xassociated names Active substance Ezetimibe simvastatin Therapeutic area … product specific waiver for ezetimibe / simvastatin (Inegy and … product specific waiver for ezetimibe / simvastatin (Inegy and … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002257-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XKey facts Rosuvastatin Ezetimibe Cardiovascular diseasesP/0090/2018EMEA-002257-PIP01-17 … waiver for rosuvastatin / ezetimibe (EMEA-002257-PIP01-17) PDF … waiver for rosuvastatin / ezetimibe (EMEA-002257-PIP01-17) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001344-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/04/2018, Last updated: 26/07/2018, Compliance check: XSuvezen Active substance Ezetimibe Rosuvastatin Therapeutic … Ezetimibe Rosuvastatin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-002202-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: XActive substance Rosuvastatin Ezetimibe Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … waiver for rosuvastatin / ezetimibe (EMEA-002202-PIP01-17 … waiver for rosuvastatin / ezetimibe (EMEA-002202-PIP01-17) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002202-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/07/2020, Last updated: 17/06/2021, Compliance check: XKey facts Rosuvastatin Ezetimibe Cardiovascular diseasesP/0251/2020EMEA-002202-PIP02-20 … waiver for rosuvastatin / ezetimibe (Coroswera) (EMEA-002202-PIP02-20 … waiver for rosuvastatin / ezetimibe (Coroswera), (EMEA-002202-PIP02-20 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, atorvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001477-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/10/2013, Last updated: 18/11/2013, Compliance check: XActive substance Ezetimibe atorvastatin Therapeutic … product specific waiver for ezetimibe / atorvastatin (EMEA-001477-PIP01-13 … product specific waiver for ezetimibe / atorvastatin (EMEA-001477-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001478-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/10/2013, Last updated: 18/11/2013, Compliance check: XActive substance Ezetimibe Rosuvastatin Therapeutic … product specific waiver for ezetimibe / rosuvastatin (EMEA-001478-PIP01-13 … product specific waiver for ezetimibe / rosuvastatin (EMEA-001478-PIP01-13 …