6774 results
Keyword Artrotec 75 Remove keyword
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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: 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 (updated)
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: 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, Positive, Last updated: 27/08/2020EU/3/10/751 … orphan designation (EU/3/10/751) was granted by the European … marketing authorisation. EU/3/10/751: 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 … orphan designation (EU/3/10/753) was granted by the European … marketing authorisation. EU/3/10/753: 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): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,
, 
, 
, Revision: 8, Authorised, Last updated: 17/08/2021
PDF/101.97 KB) Danish (PDF/75.75 KB) (PDF 75.75 KB) Dutch (PDF 75.87 KB) (PDF 75.87 KB) Estonian (PDF/74.54 KB … -
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Human medicine European public assessment report (EPAR): Adrovance
colecalciferol, alendronic acid (as sodium trihydrate), Osteoporosis, Postmenopausal
Date of authorisation: 04/01/2007, Revision: 23, Authorised, Last updated: 09/09/2021 -
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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): Altargo
retapamulin, Impetigo; Staphylococcal Skin Infections
Date of authorisation: 24/05/2007, Revision: 15, Withdrawn, Last updated: 15/03/2019PDF icon application/pdf h-757_en.pdf PDF icon application/pdf … PDF icon application/pdf h-757_lv.pdf PDF icon application/pdf … PDF icon application/pdf h-757_mt.pdf PDF icon application/pdf … -
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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: 7, Authorised, Last updated: 29/07/2021PDF/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): Reagila
cariprazine hydrochloride, Schizophrenia
Date of authorisation: 13/07/2017,, Revision: 3, Authorised, Last updated: 31/08/2021
PDF/73.72 KB) French (PDF/75.9 KB) (PDF 75.9 KB) German (PDF 75.94 KB) (PDF 75.94 KB) Greek (PDF/103.61 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 … -
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Human medicine European public assessment report (EPAR): Descovy
emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/04/2016, Revision: 18, Authorised, Last updated: 22/06/2021Summary for the public (PDF/75.65 KB … -
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Human medicine European public assessment report (EPAR): Caspofungin Accord
caspofungin acetate, Candidiasis; Aspergillosis
Date of authorisation: 11/02/2016,
, Revision: 6, Withdrawn, Last updated: 20/08/2021
languages (22) Bulgarian (PDF/750.15 KB) (PDF 750.15 KB) Croatian (PDF/674.11 … PDF/656.16 KB) Greek (PDF/752.71 KB) (PDF 752.71 KB) Hungarian (PDF/721.62 … 8400 Facsimile +44 (0)20 7523 7129 E-mail info@ema.europa.eu … -
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Human medicine European public assessment report (EPAR): Alprolix
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,, , Revision: 7, Authorised, Last updated: 17/03/2021
year on average and around 75% of bleeding episodes resolved … year on average and around 75% of bleeding episodes resolved … -
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Veterinary medicine European public assessment report (EPAR): Coliprotec F4/F18
Live non-pathogenic Escherichia coli O141:K94 (F18ac) and O8:K87 (F4ac), Pigs
Date of authorisation: 09/01/2017, Revision: 4, Authorised, Last updated: 12/05/2021PDF/91.13 KB) Dutch (PDF/75.26 KB) (PDF 75.26 KB) Estonian (PDF/118.28 … PDF/136.23 KB) French (PDF/93.75 KB) (PDF/93 75 KB) German (PDF/94.44 KB …