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Human medicine European public assessment report (EPAR): Turalio
Pexidartinib, Giant Cell Tumor of Tendon Sheath; Synovitis, Pigmented Villonodular
Date of refusal: 28/10/2020,
, 
, Refused, Last updated: 18/12/2020
Turalio Giant Cell Tumor of Tendon Sheath Synovitis … treatment of tenosynovial giant cell tumour. The Agency issued … adults with tenosynovial giant cell tumour that can cause … -
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,
, , Revision: 13, Authorised, Last updated: 17/07/2023
Diseases Immunoproliferative Disorders Giant Lymph Node Hyperplasia … siltuximab Therapeutic area (MeSH) Giant Lymph Node Hyperplasia Anatomical … -
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Human medicine European public assessment report (EPAR): RoActemra
tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection
Date of authorisation: 15/01/2009, Revision: 41, Authorised, Last updated: 16/10/2023Rheumatoid Cytokine Release Syndrome Giant Cell Arteritis COVID-19 … used to treat: adults with giant cell arteritis, a disease … idiopathic polyarthritis, giant cell arteritis, CRS and COVID-19 … -
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Direct healthcare professional communication (DHPC): Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab)
Active substance: tocilizumab, Emicizumab, trastuzumab, trastuzumab emtansine, rituximab, pertuzumab, trastuzumab, atezolizumab, DHPC type: Quality defect, Last updated: 17/08/2023Rheumatoid Cytokine Release Syndrome Giant Cell Arteritis COVID-19 … Cytokine Release Syndrome Giant Cell Arteritis COVID-19 virus … -
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Human medicine European public assessment report (EPAR): Tyenne
tocilizumab, Arthritis, Rheumatoid; Cytokine Release Syndrome; Arthritis, Juvenile Rheumatoid; COVID-19 virus infection; Giant Cell Arteritis
Date of authorisation: 15/09/2023,
, Authorised, Last updated: 02/10/2023
Rheumatoid COVID-19 virus infection Giant Cell Arteritis … used to treat: adults with giant cell arteritis, a disease … idiopathic polyarthritis, giant cell arteritis, CRS and COVID-19 … -
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Human medicine European public assessment report (EPAR): Xgeva
denosumab, Fractures, Bone; Neoplasm Metastasis
Date of authorisation: 13/07/2011, Revision: 24, Authorised, Last updated: 17/07/2023type of bone cancer called giant cell tumour of bone in adults … upper arm. In patients with giant cell tumour of bone, 120 mg … less likely. The cells in giant cell tumour of bone are also … -
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Orphan designation: [5-(5-chloro-1H-pyrrolo[2,3-b]pyridin-3-ylmethyl)-pyridin-2-yl]-(6-trifluoromethyl-pyridin-3-ylmethyl)-amine hydrochloride for: Treatment of tenosynovial giant cell tumour, localised and diffuse type
Date of designation: 19/03/2015, Withdrawn, Last updated: 02/02/2022treatment of tenosynovial giant cell tumour, localised and … -
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Orphan designation: Cabiralizumab for: Treatment of tenosynovial giant cell tumour, localised and diffuse type
Date of designation: 12/12/2016, Withdrawn, Last updated: 12/08/2020treatment of tenosynovial giant cell tumour, localised and … -
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Orphan designation: 2-(isopropylamino)-3-methyl-5-(6-methyl-5-((2-(1-methyl-1H-pyrazol-4-yl)pyridin-4-yl)oxy)pyridin-2-yl)pyrimidin-4(3H)-one for: Treatment of tenosynovial giant cell tumour, localised and diffuse type
Date of designation: 16/12/2019, Positive, Last updated: 25/08/2021treatment of tenosynovial giant cell tumour, localised and … -
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Orphan designation: Recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor (lacnotuzumab)
Date of designation: 15/10/2014, Positive, Last updated: 04/06/2018treatment of tenosynovial giant cell tumour, localised and … section What is tenosynovial giant cell tumour, localised and … diffused type? Tenosynovial giant cell tumour is a condition … -
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Orphan designation: Emactuzumab for: Treatment of tenosynovial giant cell tumour, localised and diffuse type
Date of designation: 16/03/2022, Positive, Last updated: 20/06/2022treatment of tenosynovial giant-cell tumour, local and diffuse … -
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Orphan designation: Adeno-associated virus vector serotype 9 encoding human gigaxonin gene for: Treatment of giant axonal neuropathy
Date of designation: 13/04/2022, Positive, Last updated: 19/07/2022designation for the treatment of giant axonal neuropathy … -
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Human medicine European public assessment report (EPAR): Votubia
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011, Revision: 30, Authorised, Last updated: 27/06/2022tuberous sclerosis: subependymal giant cell astrocytoma (SEGA … sclerosis: • subependymal giant cell astrocytoma (SEGA … -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP02-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 22/01/2014, Last updated: 19/02/2014, Compliance check: V, 29/01/2016Treatment of subependymal giant-cell astrocytoma Route(s) of administration … Treatment of subependymal giant cell astrocytoma Treatment … treatment of subependymal giant cell astrocytoma 2.1.1 … -
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Orphan designation: everolimus for: Treatment of tuberous sclerosis
Date of designation: 04/08/2010, Expired, Last updated: 15/09/2023and older with subependymal giant-cell astrocytoma (SEGA) associated … and older with subependymal giant-cell astrocytoma (SEGA) associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Emactuzumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-003172-PIP01-21, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 02/12/2022, Last updated: 26/10/2023, Compliance check: XTreatment of tenosynovial giant cell tumour Intravenous use … Treatment of tenosynovial giant cell tumour, local and diffuse … Treatment of tenosynovial giant cell tumour, local and diffuse … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vimseltinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002802-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 11/03/2022, Last updated: 17/04/2023, Compliance check: XTreatment of tenosynovial giant cell tumour Oral use Deciphera … Treatment of tenosynovial giant cell tumour Pharmaceutical … Treatment of tenosynovial giant cell tumour The waiver … -
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Opinion/decision on a Paediatric investigation plan (PIP): Prolia, denosumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000145-PIP01-07-M09, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/03/2018, Last updated: 21/09/2021, Compliance check: V, 01/03/2019idiopathic arthritis) Treatment of giant cell tumour of bone Treatment … metastases Treatment of giant cell tumour of bone Treatment … Condition: Treatment of giant cell tumour of bone The … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)20-23 June 2011
CHMP, Last updated: 24/06/2011and older with subependymal giant-cell astrocytoma (SEGA) associated … and older with subependymal giant-cell astrocytoma (SEGA) associated … -
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News: EMA recommends approval for use of RoActemra in adults with severe COVID-19
CHMP, Last updated: 06/12/2021idiopathic polyarthritis, giant cell arteritis and cytokine … -
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National expert: Dimitrios Filippou, National Organization For Medicines (updated)
- Declaration of interests - 39.32 KB | PDF
- Curriculum Vitae - 76.33 KB | PDF
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Human medicine European public assessment report (EPAR): Orphacol
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, 
, Revision: 13, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Hyftor
Sirolimus, Angiofibroma; Tuberous Sclerosis
Date of authorisation: 15/05/2023,, Revision: 2, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Mylotarg (updated)
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,, Revision: 12, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Byannli (previously Paliperidone Janssen-Cilag International)
paliperidone palmitate, Schizophrenia
Date of authorisation: 18/06/2020, Revision: 3, Authorised, Last updated: 23/06/2023