9777 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: XKey facts EGFR-cMET bispecific antibody OncologyP/0289/2019EMEA-002573-PIP01-19 … product specific waiver for EGFR-cMET bispecific antibody (EMEA-002573-PIP01-19 … 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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … 8400 Facsimile +44 (0)20 7523 7129 E-mail info@ema.europa.eu … authorisation application for Egrifta (tesamorelin) On 21 June … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mixture of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis (Grasses-Mix) and Secale cereale (75/25) allergen extracts
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000923-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 26/11/2010, Last updated: 21/12/2010, Compliance check: XGrasses-Mix) and Secale cereale (75/25) allergen extracts Pneumology-allergologyP/263/2010EMEA-000923-PIP01-10 … Grasses-Mix) and Secale cereale (75/25) allergen extracts (EMEA-000923- PIP02-10 … Grasses-Mix) and Secale cereale (75/25) allergen extracts (EMEA-000923- PIP02-10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of equal amounts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (Cultivated Rye) pollen (75/25)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000791-PIP01-09, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 26/11/2010, Last updated: 21/12/2010, Compliance check: XCultivated Rye) pollen (75/25) Pneumology-allergologyP/247/2010EMEA-000791-PIP01-09 … Cultivated Rye) pollen (75/25) (EMEA-000791-PIP01-09 … Cultivated Rye) pollen (75/25) (EMEA-000791-PIP01-09 … -
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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 … 8400 Facsimile +44 (0)20 7523 7455 E-mail info@ema.europa.eu … -
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Opinion/decision on a Paediatric investigation plan (PIP): 3-[5-[(1R,2S)-2-(2,2-difluoropropanoylamino)-1-(2,3-dihydro-1,4-benzodioxin-6-yl)propoxy]indazol-1- yl]-N-[(3R)-tetrahydrofuran-3-yl]benzamide (AZD7594)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-001976-PIP02-18, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, Nebuliser suspension, Pressurised inhalation suspension
Decision date: 20/12/2019, Last updated: 31/03/2020, Compliance check: Xyl]-N-[(3R)-tetrahydrofuran-3-yl]benzamide (AZD7594) Pneumology-allergologyP/0402/2019EMEA-001976-PIP02-18 … yl]-N-[(3R)-tetrahydrofuran-3-yl]benzamide (AZD7594 … -
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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, 12/12/20148400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … strain (X-179A)*propagated in eggs. … -
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Orphan designation: Sequence-modified recombinant human factor VIIa for: Treatment of haemophilia A
Date of designation: 09/10/2009, Withdrawn, Last updated: 19/01/2016EU/3/09/675 … orphan designation (EU/3/09/675) was granted by the European … marketing authorisation. EU/3/09/675: Public summary of positive … -
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Press release: Committee for veterinary medicinal products: 75th meeting
CVMP, Last updated: 15/03/2002veterinary medicinal products: 75th meeting … -
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National expert: Egbert Flory, Paul Ehrlich Institute (updated)
- Declaration of interests - 80.04 KB | PDF
- Curriculum Vitae - 22.08 KB | PDF
Egbert Flory … Egbert Flory … Vitae PERSONAL INFORMATION Egbert Flory WORK EXPERIENCE … -
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Orphan designation: 6alpha-ethyl-chenodeoxycholic acid for: Treatment of primary biliary cirrhosis
Date of designation: 27/07/2010, Positive, Last updated: 21/11/2022EU/3/10/753 … EU/3/10/753: Orphan designation for the … the designation EU/3/10/753 for Ocaliva (obeticholic … -
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Orphan designation: velaglucerase alfa for: Treatment of Gaucher disease
Date of designation: 06/06/2010, Expired, Last updated: 09/09/2022EU/3/10/752 … orphan designation (EU/3/10/752) was granted by the European … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (teprasiran) for: Prevention of delayed graft function after renal transplantation
Date of designation: 06/06/2010, Withdrawn, Last updated: 28/02/2022EU/3/10/751 … orphan designation (EU/3/10/751) was granted by the European … designation evaluation: EU/3/10/751: Public summary of opinion … -
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Orphan designation: Tranilast for: Prevention of scarring post glaucoma filtration surgery
Date of designation: 27/07/2010, Positive, Last updated: 13/10/2021EU/3/10/756 … orphan designation (EU/3/10/756) was granted by the European … filtration surgeryPositiveEU/3/10/756 27/07/2010 Voisin Consulting … -
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Orphan designation: Heparin-activated recombinant human fibroblast growth factor 1 (on a biodegradable device made from alpha-calcium sulfate hemihydrate) for: Treatment of traumatic spinal cord injury
Date of designation: 27/07/2010, Withdrawn, Last updated: 03/02/2021EU/3/10/754 … orphan designation (EU/3/10/754) was granted by the European … marketing authorisation. EU/3/10/754: Public summary of opinion … -
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Orphan designation: octenidine dihydrochloride for: Prevention of late-onset sepsis in premature infants of ≤ to 32 weeks of gestational age
Date of designation: 27/07/2010, Positive, Last updated: 05/08/2010EU/3/10/755 … orphan designation (EU/3/10/755) was granted by the European … marketing authorisation. EU/3/10/755: Public summary of opinion … -
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Orphan designation: Pomalidomide for: Treatment of post-essential thrombocythaemia myelofibrosis
Date of designation: 27/07/2010, Withdrawn, Last updated: 10/02/2017EU/3/10/759 … orphan designation (EU/3/10/759) was granted by the European … marketing authorisation. EU/3/10/759: Public summary of opinion … -
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Orphan designation: Pomalidomide for: Treatment of post-polycythaemia vera myelofibrosis
Date of designation: 27/07/2010, Withdrawn, Last updated: 10/02/2017EU/3/10/758 … orphan designation (EU/3/10/758) was granted by the European … marketing authorisation. EU/3/10/758: Public summary of opinion … -
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Orphan designation: Pomalidomide for: Treatment of primary myelofibrosis
Date of designation: 27/07/2010, Withdrawn, Last updated: 10/02/2017EU/3/10/757 … orphan designation (EU/3/10/757) was granted by the European … marketing authorisation. EU/3/10/757: Public summary of opinion … -
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Orphan designation: Rifapentine for: Treatment of tuberculosis
Date of designation: 09/06/2010, Positive, Last updated: 09/04/2013EU/3/10/750 … orphan designation (EU/3/10/750) was granted by the European … marketing authorisation. EU/3/10/750: Public summary of positive …