1196 results
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National expert: Leticia Martinez Peyrat, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 39.34 KB | PDF
- Curriculum Vitae - 25.64 KB | PDF
low dosage forms, direct compression, ordered mixing, sugar spheres … Active Layering and Direct Compression of Sugar Spheres. Leticia … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 June 2012
CHMP, Last updated: 22/06/2012pathological fractures, spinal compression, radiation or surgery to bone … -
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Press release: European Medicines Agency finds no signal for decreased effectiveness of HBVAXPRO and Procomvax
Last updated: 08/05/2006where infants receive the compressed administration schedule at … where infants receive the compressed administration schedule at … -
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News: EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
Last updated: 05/10/2020treat and prevent COVID-19, compressing a process that typically … -
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Orphan designation: Rilonacept for: Treatment of idiopathic pericarditis
Date of designation: 06/01/2021, Positive, Last updated: 30/01/2023risk of cardiac tamponade (compression of the heart caused by fluid … risk of cardiac tamponade (compression of the heart caused by fluid … -
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National expert: Stefanie Farrugia, Medicines Authority (updated)
- Declaration of interests - 40.11 KB | PDF
- Curriculum Vitae - 34.21 KB | PDF
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Human medicine European public assessment report (EPAR): Abiraterone Accord (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021,
, Revision: 1, Authorised, Last updated: 25/09/2023
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Human medicine European public assessment report (EPAR): Mepsevii (updated)
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,
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, Revision: 7, Authorised, Last updated: 14/09/2023
• Spinal/Cervical Cord Compression • Immunogenicity Missing … Risk: Spinal/Cervical Cord Compression Evidence for linking the … -
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National expert: Oliver Semler, European Medicines Agency (updated)
- Declaration of interests - 40.47 KB | PDF
- Curriculum Vitae - 118.61 KB | PDF
of motor dysfunction after compression spinal cord • 4.28 Page … -
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Human medicine European public assessment report (EPAR): Reblozyl
Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia
Date of authorisation: 25/06/2020,, , Revision: 5, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau) (updated)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,, , , Revision: 6, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Procysbi (updated)
mercaptamine bitartrate, Cystinosis
Date of authorisation: 05/09/2013, Revision: 16, Authorised, Last updated: 22/09/2023 -
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Human medicine European public assessment report (EPAR): Clopidogrel / Acetylsalicylic acid Mylan (updated)
Acetylsalicylic acid, clopidogrel hydrogen sulfate, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 09/01/2020,, Revision: 5, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Viagra (updated)
sildenafil, Erectile Dysfunction
Date of authorisation: 13/09/1998, Revision: 45, Authorised, Last updated: 18/09/2023 -
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Human medicine European public assessment report (EPAR): Aquipta
atogepant, Migraine Disorders
Date of authorisation: 11/08/2023,, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Lutathera (updated)
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 10, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Glyxambi (updated)
empagliflozin, linagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 11/11/2016, Revision: 16, Authorised, Last updated: 27/09/2023 -
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Human medicine European public assessment report (EPAR): Voxzogo (updated)
Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021,, , Revision: 3, Authorised, Last updated: 06/09/2023
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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): Rivaroxaban Accord (updated)
rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020,, Revision: 5, Authorised, Last updated: 28/09/2023
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Human medicine European public assessment report (EPAR): Epclusa (updated)
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,
, Revision: 22, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Erleada (updated)
apalutamide, Prostatic Neoplasms
Date of authorisation: 14/01/2019,, Revision: 11, Authorised, Last updated: 27/09/2023
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Human medicine European public assessment report (EPAR): Hefiya (updated)
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,
, Revision: 14, Authorised, Last updated: 20/09/2023
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Human medicine European public assessment report (EPAR): Hyrimoz (updated)
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018,, Revision: 13, Authorised, Last updated: 20/09/2023
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Human medicine European public assessment report (EPAR): Cialis (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 12/11/2002, Revision: 31, Authorised, Last updated: 20/09/2023