6754 results
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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 Therapeutic … 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) Therapeutic area Pneumology-allergology … Cultivated Rye) pollen (75/25) (EMEA-000791-PIP01-09 … Cultivated Rye) pollen (75/25) (EMEA-000791-PIP01-09 … -
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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) Therapeutic area Pneumology-allergology … yl]-N-[(3R)-tetrahydrofuran-3-yl]benzamide (AZD7594 … -
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Press release: Committee for veterinary medicinal products: 75th meeting
CVMP, Last updated: 15/03/2002veterinary medicinal products: 75th meeting … veterinary medicinal products: 75th meeting … -
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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 first decision: 27/07/2010, Withdrawn, Last updated: 03/02/2021EU/3/10/754 … EU/3/10/754 … 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 first decision: 06/06/2010, Positive, Last updated: 27/08/2020EU/3/10/751 … EU/3/10/751 … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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Orphan designation: 6alpha-ethyl-chenodeoxycholic acid for: Treatment of primary biliary cirrhosis
Date of first decision: 27/07/2010, Positive, Last updated: 19/12/2016EU/3/10/753 … EU/3/10/753 … the designation EU/3/10/753 for Ocaliva (obeticholic … -
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Orphan designation: Pomalidomide for: Treatment of post-essential thrombocythaemia myelofibrosis
Date of first decision: 27/07/2010, Withdrawn, Last updated: 10/02/2017EU/3/10/759 … EU/3/10/759 … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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Orphan designation: Pomalidomide for: Treatment of primary myelofibrosis
Date of first decision: 27/07/2010, Withdrawn, Last updated: 10/02/2017EU/3/10/757 … EU/3/10/757 … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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Orphan designation: Pomalidomide for: Treatment of post-polycythaemia vera myelofibrosis
Date of first decision: 27/07/2010, Withdrawn, Last updated: 10/02/2017EU/3/10/758 … EU/3/10/758 … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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Orphan designation: velaglucerase alfa for: Treatment of Gaucher disease
Date of first decision: 06/06/2010, Positive, Last updated: 23/06/2010EU/3/10/752 … EU/3/10/752 … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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Orphan designation: Rifapentine for: Treatment of tuberculosis
Date of first decision: 09/06/2010, Positive, Last updated: 09/04/2013EU/3/10/750 … EU/3/10/750 … orphan designation (EU/3/10/750) was granted by the European … -
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Orphan designation: Tranilast for: Prevention of scarring post glaucoma filtration surgery
Date of first decision: 27/07/2010, Positive, Last updated: 06/08/2010EU/3/10/756 … EU/3/10/756 … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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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 first decision: 27/07/2010, Positive, Last updated: 05/08/2010EU/3/10/755 … EU/3/10/755 … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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Orphan designation: velaglucerase alfa for: Treatment of Gaucher disease
Date of first decision: 06/06/2010, Positive, Last updated: 23/06/2010EU/3/10/752 … EU/3/10/752 … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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National expert: Armando Magrelli, Italian Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 27.51 KB | PDF
Computer systems analyst Con Soluzioni Con Srl (Italy) Main activities … -
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Human medicine European public assessment report (EPAR): Prepandrix (updated)
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 14/05/2008,
, Revision: 13, Withdrawn, Last updated: 23/02/2021
PDF/782.77 KB) Hungarian (PDF/753.62 KB) (PDF 753.62 KB) Italian (PDF/654.6 KB … PDF/654.6 KB) Latvian (PDF/750.57 KB) (PDF 750.57 KB) Lithuanian (PDF/705.98 … -
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,
, 
, Revision: 24, Authorised, Last updated: 04/12/2020
PDF icon application/pdf h-752-summary_en.pdf PDF icon application/pdf … PDF icon application/pdf h-752-summary_bg.pdf PDF icon application/pdf … PDF icon application/pdf h-752-summary_cs.pdf PDF icon application/pdf … -
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Human medicine European public assessment report (EPAR): Zaltrap
aflibercept, Colorectal Neoplasms
Date of authorisation: 01/02/2013, Revision: 9, Authorised, Last updated: 23/11/2020Last updated: 12/10/2017 EMA/750113/2012 Click to see translations … PDF/100.73 KB) Danish (PDF/75.12 KB) (PDF 75.12 KB) Dutch (PDF 75.71 KB) (PDF … -
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Human medicine European public assessment report (EPAR): Nerlynx
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018,, Revision: 6, Authorised, Last updated: 13/11/2020
Medicine overview (PDF/76.75 KB … -
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Human medicine European public assessment report (EPAR): Afstyla
lonoctocog alfa, Hemophilia A
Date of authorisation: 04/01/2017,, Revision: 7, Authorised, Last updated: 26/08/2020
Summary for the public (PDF/75.85 KB … is acknowledged. EMA/753310/2016 EMEA/H/C/004075 EPAR … readily. Afstyla EMA/753310/2016 Page 2/3 The active substance … -
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Human medicine European public assessment report (EPAR): Vihuma
simoctocog alfa, Hemophilia A
Date of authorisation: 13/02/2017,, Revision: 4, Authorised, Last updated: 09/09/2020
Medicine overview (PDF/75.08 KB … Lars Forssells gata 23 112 75 Stockholm SWEDEN Active … -
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Veterinary medicine European public assessment report (EPAR): Galliprant
grapiprant, Dogs
Date of authorisation: 09/01/2018, Revision: 4, Authorised, Last updated: 16/06/2020PDF/100.36 KB) Danish (PDF/75.3 KB) (PDF 75.3 KB) Dutch (PDF 75.89 KB) (PDF 75.89 KB) Estonian (PDF/74.81 KB … -
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Human medicine European public assessment report (EPAR): Semglee
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, 
, Revision: 5, Authorised, Last updated: 12/11/2020
PDF/73.11 KB) French (PDF/75.54 KB) (PDF 75.54 KB) German (PDF 75.82 KB) (PDF 75.82 KB) Greek (PDF/110.6 KB … -
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Human medicine European public assessment report (EPAR): Macimorelin Aeterna Zentaris
macimorelin acetate, Diagnostic Techniques, Endocrine
Date of authorisation: 11/01/2019,, Revision: 1, Authorised, Last updated: 04/11/2020
PDF/73.27 KB) Dutch (PDF/75.16 KB) (PDF 75.16 KB) Estonian (PDF/72.93 KB … PDF/73.37 KB) French (PDF/75.86 KB) (PDF 75.86 KB) German (PDF/76.09 KB …