7626 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 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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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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Press release: Committee for veterinary medicinal products: 75th meeting
CVMP, Last updated: 15/03/2002veterinary medicinal products: 75th meeting … -
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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: 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 … -
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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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Human medicine European public assessment report (EPAR): Cotellic (updated)
cobimetinib hemifumarate, Melanoma
Date of authorisation: 20/11/2015, Revision: 13, Authorised, Last updated: 17/01/2023PDF/74.89 KB) Dutch (PDF/75.89 KB) (PDF 75.89 KB) Estonian (PDF/74.4 KB … PDF/96.62 KB) Italian (PDF/75.18 KB) (PDF 75.18 KB) Latvian (PDF/104.98 KB … -
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Human medicine European public assessment report (EPAR): Zaltrap
aflibercept, Colorectal Neoplasms
Date of authorisation: 01/02/2013, Revision: 13, Authorised, Last updated: 21/12/2022Last 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): Vihuma
simoctocog alfa, Hemophilia A
Date of authorisation: 13/02/2017,
, Revision: 7, Authorised, Last updated: 21/11/2022
Medicine overview (PDF/75.08 KB … Lars Forssells gata 23 112 75 Stockholm SWEDEN Active … -
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Human medicine European public assessment report (EPAR): Mylotarg
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,, 
, Revision: 11, Authorised, Last updated: 14/12/2022
Summary for the public (PDF/75.51 KB … -
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Human medicine European public assessment report (EPAR): Nerlynx
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018,, Revision: 12, Authorised, Last updated: 05/12/2022
Medicine overview (PDF/76.75 KB … -
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Human medicine European public assessment report (EPAR): Alecensa (updated)
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,, Revision: 13, Authorised, Last updated: 23/01/2023
PDF/101.27 KB) Danish (PDF/75.18 KB) (PDF 75.18 KB) Dutch (PDF 75.68 KB) (PDF 75.68 KB) Estonian (PDF/74.14 KB … -
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Human medicine European public assessment report (EPAR): Afstyla
lonoctocog alfa, Hemophilia A
Date of authorisation: 04/01/2017, Revision: 10, Authorised, Last updated: 25/07/2022Summary 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): Oncaspar (updated)
pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016, Revision: 16, Authorised, Last updated: 25/01/2023newly diagnosed with ALL, 75% of those treated with Oncaspar … -
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Human medicine European public assessment report (EPAR): Zubsolv
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 8, Authorised, Last updated: 29/07/2022PDF/100.06 KB) Danish (PDF/75.05 KB) (PDF 75.05 KB) Dutch (PDF 75.41 KB) (PDF 75.41 KB) Estonian (PDF … -
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Human medicine European public assessment report (EPAR): Glustin
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 11/10/2000, Revision: 28, Withdrawn, Last updated: 17/10/2022PDF/696.95 KB) Czech (PDF/756.82 KB) (PDF 756.82 KB) Danish (PDF/676.89 KB … PDF/676.4 KB) Latvian (PDF/752.68 KB) (PDF 752.68 KB) Lithuanian (PDF/702.48 … -
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Human medicine European public assessment report (EPAR): Karvea (updated)
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 45, Authorised, Last updated: 02/02/2023is available as tablets (75, 150 and 300 mg). What is … hydrochlorothiazide. A starting dose of 75 mg can be used in patients … technique) or in patients over 75 years of age. In patients …