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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: 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: velaglucerase alfa for: Treatment of Gaucher disease
Date of designation: 06/06/2010, Positive, Last updated: 24/09/2021EU/3/10/752 … EU/3/10/752: Orphan designation for the … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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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: 6alpha-ethyl-chenodeoxycholic acid for: Treatment of primary biliary cirrhosis
Date of designation: 27/07/2010, Positive, Last updated: 19/12/2016EU/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: 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): Zubsolv (updated)
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): Zaltrap
aflibercept, Colorectal Neoplasms
Date of authorisation: 01/02/2013, Revision: 11, Authorised, Last updated: 15/07/2022Last 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): Nerlynx
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018,
, Revision: 11, Authorised, Last updated: 05/07/2022
Medicine overview (PDF/76.75 KB … -
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Human medicine European public assessment report (EPAR): Cotellic
cobimetinib hemifumarate, Melanoma
Date of authorisation: 20/11/2015, Revision: 12, Authorised, Last updated: 14/06/2022PDF/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): Ikervis
ciclosporin, Corneal Diseases
Date of authorisation: 19/03/2015, Revision: 9, Authorised, Last updated: 28/01/2022PDF/74.81 KB) Dutch (PDF/75.79 KB) (PDF 75.79 KB) Estonian (PDF/74.41 KB … PDF/74.41 KB) Finnish (PDF/75.39 KB) (PDF 75.39 KB) French (PDF/79.21 KB … -
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Human medicine European public assessment report (EPAR): Memantine Accord
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 03/12/2013,
, Revision: 7, Authorised, Last updated: 13/01/2022
Summary for the public (PDF/75.62 KB … 8400 Facsimile +44 (0)20 7523 7129 E-mail info@ema.europa.eu … -
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Veterinary medicine European public assessment report (EPAR): Galliprant
grapiprant, Dogs
Date of authorisation: 09/01/2018, Revision: 5, Authorised, Last updated: 17/08/2021PDF/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): Jevtana
cabazitaxel, Prostatic Neoplasms
Date of authorisation: 17/03/2011, Revision: 20, Authorised, Last updated: 14/12/2021one main study involving 755 men with metastatic castration-resistant … one main study involving 755 men with metastatic castration-resistant … -
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Human medicine European public assessment report (EPAR): Semglee
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, 
, Revision: 6, Authorised, Last updated: 14/01/2022
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): Kyntheum
brodalumab, Psoriasis
Date of authorisation: 17/07/2017, Revision: 5, Authorised, Last updated: 10/05/2022with Kyntheum obtained a 75% reduction in PASI scores … with Kyntheum obtained a 75% reduction in PASI scores … -
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Human medicine European public assessment report (EPAR): Opsumit
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,
, Revision: 20, Authorised, Last updated: 29/06/2022
PDF/101.95 KB) Danish (PDF/75.72 KB) (PDF 75.72 KB) Dutch (PDF/76.1 KB) (PDF/76.1 … PDF/76.1 KB) Estonian (PDF/75.62 KB) (PDF 75.62 KB) Finnish (PDF …