408 results
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Opinion/decision on a Paediatric investigation plan (PIP): Zometa, zoledronic acid
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000024-PIP01-07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion, Concentrate for solution for infusion
Decision date: 24/06/2008, Last updated: 21/07/2008, Compliance check: V, 12/12/2008breast cancer treated with aromatase inhibitors Prevention of … breast cancer treated with aromatase inhibitors Pharmaceutical … breast cancer treated with aromatase inhibitors in o Subset(s … -
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Press release: New treatment for breast cancer
CHMP, Last updated: 16/09/2016used in combination with an aromatase inhibitor or with fulvestrant … palbociclib and letrozole, an aromatase inhibitor, with letrozole … used in combination with an aromatase inhibitor or with fulvestrant … -
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Press release: Novartis withdraws its application to extend the marketing authorisation for Zometa
CHMP, Last updated: 20/11/2007breast cancer treated with aromatase inhibitors. At the time of … breast cancer treated with aromatase inhibitors. At the time of … -
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Press release: GlaxoSmithKline withdraws its application for an extension of the indication for Tyverb (lapatinib)
Last updated: 16/02/2012setting; in combination with an aromatase inhibitor for postmenopausal … in combination with an aromatase inhibitor for postmenopausal … -
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Press release: Novartis Europharm Ltd. withdraws its application for an extension of indication for Zometa (zoledronic acid)
Last updated: 15/12/2010breast cancer treated with aromatase inhibitors. Novartis Europharm … breast cancer treated with aromatase inhibitors. 4. More information … -
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National expert: Everaldo Attard, Medicines Authority (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 63.64 KB | PDF
Activities: Working on the Aromatic and Medicinal Plant Research … in Agricultural Chemistry_Aromatic & Medicinal Plants Research … in Agricultural Chemistry_Aromatic & Medicinal Plants Research … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18 February 2010
CHMP, Last updated: 19/02/2010ErbB2), in combination with an aromatase inhibitor in postmenopausal … treated with trastuzumab or an aromatase inhibitor … ErbB2), in combination with an aromatase inhibitor in postmenopausal … -
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News: First therapy to treat rare genetic nervous system disorder AADC deficiency
CHMP, Last updated: 20/05/2022paediatric patients with severe aromatic L-amino acid decarboxylase … -
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National expert: Caroline Coner, Ministry Of Health (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 24.77 KB | PDF
Degree in Phytotherapy and Aromatherapy • Organisation: phytotherapy aromatherapy plants • Country: France 2 … -
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Human medicine European public assessment report (EPAR): Prolia (updated)
denosumab, Bone Resorption; Osteoporosis, Postmenopausal
Date of authorisation: 26/05/2010, Revision: 27, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,
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, Revision: 16, Authorised, Last updated: 05/09/2023
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Human medicine European public assessment report (EPAR): Piqray
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,, Revision: 9, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Isturisa
Osilodrostat phosphate, Cushing Syndrome
Date of authorisation: 09/01/2020,, , Revision: 5, Authorised, Last updated: 06/07/2023
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Human medicine European public assessment report (EPAR): Adempas (updated)
riociguat, Hypertension, Pulmonary
Date of authorisation: 27/03/2014, Revision: 13, Authorised, Last updated: 31/08/2023 -
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Human medicine European public assessment report (EPAR): Pergoveris
follitropin alfa, lutropin alfa, Infertility, Female
Date of authorisation: 25/06/2007, Revision: 15, Authorised, Last updated: 31/05/2023 -
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Human medicine European public assessment report (EPAR): Nerlynx
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018, Revision: 13, Authorised, Last updated: 15/06/2023 -
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National expert: Kristin Skougaard, Danish Medicines Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 38.99 KB | PDF
Skougaard K, Kamby C, Nielsen DL. Aromatasehaemmere ved metastaserende brystkraeft … postmenopausale patienter [Aromatase inhibitors for metastasing … -
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Human medicine European public assessment report (EPAR): Lynparza (updated)
Olaparib, Ovarian Neoplasms
Date of authorisation: 16/12/2014, Revision: 23, Authorised, Last updated: 21/09/2023 -
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Human medicine European public assessment report (EPAR): Pyrukynd
mitapivat sulfate, Genetic Diseases, Inborn; Anemia, Hemolytic
Date of authorisation: 09/11/2022,, , Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Perjeta
pertuzumab, Breast Neoplasms
Date of authorisation: 04/03/2013, Revision: 22, Authorised, Last updated: 29/08/2023 -
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Human medicine European public assessment report (EPAR): Vyndaqel (updated)
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,, , 
, Revision: 27, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Fulvestrant Mylan
fulvestrant, Breast Neoplasms
Date of authorisation: 08/01/2018,
, Revision: 5, Authorised, Last updated: 24/02/2023
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Human medicine European public assessment report (EPAR): Enhertu (updated)
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 12, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Zynrelef
bupivacaine, meloxicam, Pain, Postoperative
Date of authorisation: 24/09/2020, Revision: 2, Authorised, Last updated: 28/06/2023 -
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Human medicine European public assessment report (EPAR): Faslodex
fulvestrant, Breast Neoplasms
Date of authorisation: 09/03/2004, Revision: 23, Authorised, Last updated: 31/08/2022