17700 results
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva (updated)
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,
, Revision: 11, Authorised, Last updated: 25/11/2020
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Human medicine European public assessment report (EPAR): Silapo (updated)
epoetin zeta, Anemia, Blood Transfusion, Autologous, Cancer, Kidney Failure, Chronic
Date of authorisation: 18/12/2007,
, Revision: 17, Authorised, Last updated: 25/11/2020
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Human medicine European public assessment report (EPAR): Phelinun
melphalan hydrochloride, Multiple Myeloma, Hodgkin Disease, Lymphoma, Non-Hodgkin, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Neuroblastoma, Ovarian Neoplasms, Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/11/2020, Authorised, Last updated: 25/11/2020 -
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Human medicine European public assessment report (EPAR): Abraxane (updated)
paclitaxel, Breast Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 11/01/2008, Revision: 27, Authorised, Last updated: 25/11/2020 -
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Human medicine European public assessment report (EPAR): Opdivo (updated)
nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 19/06/2015, Revision: 33, Authorised, Last updated: 25/11/2020 -
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Human medicine European public assessment report (EPAR): Supemtek
Influenza A virus subtype H1N1 haemagglutinin, recombinant, Influenza A virus subtype H3N2 haemagglutinin, recombinant, Influenza B virus Victoria lineage haemagglutinin, recombinant, Influenza B virus Yamagata lineage haemagglutinin, recombinant, Influenza, Human
Date of authorisation: 16/11/2020,
, Authorised, Last updated: 25/11/2020
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Opinion/decision on a Paediatric investigation plan (PIP): Molidustat (sodium) (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001546-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral liquid
Decision date: 27/10/2014, Last updated: 25/11/2020, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): fremanezumab (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001877-PIP03-17, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 19/12/2017, Last updated: 25/11/2020, Compliance check: X -
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Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues (lumasiran) for: Treatment of primary hyperoxaluria (updated)
Date of first decision: 21/03/2016, Positive, Last updated: 25/11/2020 -
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Human medicine European public assessment report (EPAR): Oxlumo
Lumasiran sodium, Hyperoxaluria, Primary
Date of authorisation: 19/11/2020,, 
, Authorised, Last updated: 25/11/2020
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Orphan designation: Dextran sulfate low molecular weight for: Treatment of amyotrophic lateral sclerosis
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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Human medicine European public assessment report (EPAR): Edistride (updated)
dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Date of authorisation: 09/11/2015, Revision: 14, Authorised, Last updated: 25/11/2020 -
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Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate for: Treatment of long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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Orphan designation: Copper histidinate for: Treatment of Menkes disease
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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Orphan designation: Adeno-associated viral vector serotype 3B encoding shortened human ATP7B for: Treatment of Wilson's disease
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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Orphan designation: 6-((3S,4S)-4-methyl-1-(pyrimidin-2-yl-methyl)pyrrolidin-3-yl)-3-tetrahydropyran-4-yl-7H-imidazo(1,5-a)pyrazin-8-one for: Treatment of sickle cell disease
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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Human medicine European public assessment report (EPAR): Kaletra (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 19/03/2001, Revision: 55, Authorised, Last updated: 25/11/2020 -
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Orphan designation: Trehalose for: Treatment of mucopolysaccharidosis type III (Sanfilippo syndrome)
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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Orphan designation: 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile for: Treatment of von Hippel-Lindau disease
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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Orphan designation: Venglustat for: Treatment of GM2 gangliosidosis
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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Orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding glucosylceramidase beta for: Treatment of Gaucher disease
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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List of medicines under additional monitoring (updated)
Last updated: 25/11/2020 -
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Orphan designation: Autologous T cells transduced with lentiviral vector containing a tandem chimeric antigen receptor directed against CD20 and CD19 for: Treatment of diffuse large B-cell lymphoma
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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Orphan designation: Human frataxin fused to TAT cell-penetrating peptide for: Treatment of Friedreich’s ataxia
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020 -
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Orphan designation: Infigratinib for: Treatment of cholangiocarcinoma
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020