7822 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 … 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: 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 … EU/3/10/751: 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 … EU/3/10/756: Orphan designation for the … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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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 … EU/3/10/754: Orphan designation for the … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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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 … EU/3/10/759: Orphan designation for the … 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 designation: 27/07/2010, Withdrawn, Last updated: 10/02/2017EU/3/10/758 … EU/3/10/758: Orphan designation for the … 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 designation: 27/07/2010, Withdrawn, Last updated: 10/02/2017EU/3/10/757 … EU/3/10/757: Orphan designation for the … 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 designation: 09/06/2010, Positive, Last updated: 09/04/2013EU/3/10/750 … EU/3/10/750: Orphan designation for the … orphan designation (EU/3/10/750) was granted by the European … -
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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 … EU/3/10/755: Orphan designation for the … 8400 Facsimile +44 (0)20 7523 7040 E-mail info@ema.europa.eu … -
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Direct healthcare professional communication (DHPC): Supply shortage of Fasturtec (rasburicase) 7.5 mg/5 ml powder and solvent for concentrate for solution for infusion (EU/1/00/170/002)
Active substance: rasburicase, DHPC type: Medicine shortage, Last updated: 17/02/2023of Fasturtec (rasburicase) 7.5 mg/5 ml powder and solvent … of Fasturtec (rasburicase) 7.5 mg/5 ml powder and solvent … Fasturtec® (rasburicase) 7.5 mg/5 ml powder and solvent … -
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,
, 
, Revision: 14, Authorised, Last updated: 02/05/2023
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): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,, Revision: 26, Authorised, Last updated: 13/04/2023
PDF/102.13 KB) Danish (PDF/75.15 KB) (PDF 75.15 KB) Dutch (PDF 75.66 KB) (PDF 75.66 KB) Estonian (PDF/74.57 KB … -
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Human medicine European public assessment report (EPAR): Zyclara
imiquimod, Keratosis; Keratosis, Actinic
Date of authorisation: 23/08/2012, Revision: 14, Authorised, Last updated: 13/02/2023substance imiquimod at 3.75% strength (100 mg cream contains … 100 mg cream contains 3.75 mg imiquimod). Zyclara is … Zyclara is available as a 3.75% cream in individual sachets … -
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Human medicine European public assessment report (EPAR): Cotellic
cobimetinib hemifumarate, Melanoma
Date of authorisation: 20/11/2015, Revision: 14, Authorised, Last updated: 06/03/2023PDF/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): Alecensa
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,
, Revision: 14, Authorised, Last updated: 29/03/2023
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): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,
, Revision: 19, Authorised, Last updated: 21/04/2023
Summary for the public (PDF/75.64 KB … 8400 Facsimile +44 (0)20 7523 7129 E-mail info@ema.europa.eu … -
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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): 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): 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): Prevymis
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, Revision: 14, Authorised, Last updated: 08/03/2023
PDF/99.18 KB) Czech (PDF/101.75 KB) (PDF/101 75 KB) Danish (PDF/76.21 KB … PDF/76.27 KB) Estonian (PDF/75.41 KB) (PDF 75.41 KB) Finnish (PDF … is acknowledged. EMA/754186/2017 EMEA/H/C/ 004536 EPAR …