8153 results
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Human medicine European public assessment report (EPAR): Exjade (updated)
deferasirox, beta-Thalassemia; Iron Overload
Date of authorisation: 28/08/2006,
, Revision: 52, Authorised, Last updated: 20/11/2023
In chronic iron overload due to blood transfusions, one … -
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Human medicine European public assessment report (EPAR): Rivastigmine Hexal
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/12/2009, Revision: 15, Authorised, Last updated: 21/06/2023Alzheimer’s dementia or dementia due to Parkinson’s disease … Alzheimer’s dementia and dementia due to Parkinson’s disease … 541 patients with dementia due to Parkinson’s disease … -
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Human medicine European public assessment report (EPAR): Istodax
romidepsin, Lymphoma, Non-Hodgkin
Date of refusal: 12/02/2013,
, Refused, Last updated: 14/03/2013
The CHMP also noted that, due to an oversight, the company … the observed effects were due to the medicine or due to the disease characteristics … The CHMP also noted that, due to an oversight, the company … -
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Human medicine European public assessment report (EPAR): Lucentis
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetes Complications; Myopia, Degenerative; Choroidal Neovascularization
Date of authorisation: 22/01/2007, Revision: 43, Authorised, Last updated: 09/10/2023Macular oedema due to occlusion of retinal veins … treatment of visual impairment due to macular oedema secondary … treatment of visual impairment due to diabetic macular oedema … -
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Human medicine European public assessment report (EPAR): Strimvelis
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016,, , Revision: 9, Authorised, Last updated: 19/09/2023
combined immunodeficiency due to adenosine deaminase deficiency … low red blood cell counts due to their too rapid breakdown … anaemia (low blood cell counts due to damaged bone marrow … -
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Human medicine European public assessment report (EPAR): Mulpleo (previously Lusutrombopag Shionogi)
Lusutrombopag, Thrombocytopenia
Date of authorisation: 18/02/2019,, Revision: 8, Authorised, Last updated: 08/03/2023
adults with thrombocytopenia due to long-standing liver disease … with low levels of platelets due to long-standing liver disease … 3 Hepatic impairment Due to limited information available … -
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Human medicine European public assessment report (EPAR): Cayston
aztreonam lysine, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 21/09/2009, Revision: 20, Authorised, Last updated: 03/03/2023long-term lung infection due to P. aeruginosa , most of … patients with mild lung disease due to cystic fibrosis. It looked … -
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Human medicine European public assessment report (EPAR): Teriparatide Sun
teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 18/11/2022, Revision: 1, Authorised, Last updated: 08/09/2023increased risk of fractures due to long-term treatment with … glucocorticoid medications and due to other risk factors, such … increased risk of fractures due to long-term treatment with … -
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, 
, Revision: 26, Authorised, Last updated: 16/01/2023
syndrome (a complication due to the breakdown of cancer … EU. The Agency noted that, due to the small number of patients … -
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Human medicine European public assessment report (EPAR): Gardasil
human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections; Uterine Cervical Dysplasia; Condylomata Acuminata; Immunization
Date of authorisation: 20/09/2006, Revision: 48, Authorised, Last updated: 08/11/2022lesions or warts that were due to HPV infection. The women … cervix that might have been due to HPV type 16 or 18. In … developed lesions that were due to these two HPV types. A … -
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Veterinary medicine European public assessment report (EPAR): Startvac
Escherichia coli J5 inactivated, Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime-associated antigenic complex, Cattle (cows and heifers)
Date of authorisation: 11/02/2009, Revision: 3, Authorised, Last updated: 07/05/2018are known to have problems due to mastitis (inflammation … inflammation of the udder due to infection). The strengthened … number of cows with mastitis due to Staphylococcus aureus … -
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Veterinary medicine European public assessment report (EPAR): Cimalgex
cimicoxib, Dogs
Date of authorisation: 18/02/2011, Revision: 1, Authorised, Last updated: 14/01/2016management of peri-operative pain due to orthopaedic or soft-tissue … management of peri-operative pain due to orthopaedic or soft-tissue … of peri-operative pain due to orthopaedic or soft tissue … -
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Human medicine European public assessment report (EPAR): Ranivisio
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 25/08/2022,, 
, Revision: 4, Authorised, Last updated: 13/10/2023
treatment of visual impairment due to diabetic macular oedema … treatment of visual impairment due to macular oedema secondary … treatment of visual impairment due to choroidal neovascularisation … -
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Human medicine European public assessment report (EPAR): Ucedane
carglumic acid, Hyperammonemia; Amino Acid Metabolism, Inborn Errors
Date of authorisation: 23/06/2017,
, Revision: 11, Authorised, Last updated: 06/07/2022
treatment of: hyperammonaemia due to N-acetylglutamate synthase … deficiency; Hyperammonaemia due to isovaleric acidaemia … acidaemia; Hyperammonaemia due to methymalonic acidaemia … -
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Human medicine European public assessment report (EPAR): Prometax (updated)
rivastigmine, Alzheimer Disease; Parkinson Disease; Dementia
Date of authorisation: 03/12/1998, Revision: 46, Authorised, Last updated: 21/11/2023Alzheimer’s dementia or dementia due to Parkinson’s disease … 541 patients with dementia due to Parkinson’s disease … The patients with dementia due to Parkinson’s disease … -
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Human medicine European public assessment report (EPAR): Qdenga
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue
Date of authorisation: 05/12/2022,, Authorised, Last updated: 12/04/2023
effective at preventing fever due to dengue disease in children … also reduced hospitalisation due to dengue by 90%. In the … effective at preventing fever due to dengue disease in children … -
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Human medicine European public assessment report (EPAR): Arixtra
fondaparinux sodium, Venous Thrombosis; Pulmonary Embolism; Myocardial Infarction; Angina, Unstable
Date of authorisation: 20/03/2002, Revision: 35, Authorised, Last updated: 14/07/2023thromboembolic events (VTEs, problems due to the formation of blood … that changes in severity due to reduced blood flow to … events (VTEs, problems due to the formation of blood … -
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Veterinary medicine European public assessment report (EPAR): Incurin
estriol, Dogs
Date of authorisation: 24/03/2000, Revision: 7, Authorised, Last updated: 24/02/2021against urinary incontinence due to SMI in ovariohysterectomised … against urinary incontinence due to SMI in ovariohysterectomised … hormone-dependent urinary incontinence due to sphincter mechanism incompetence … -
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Human medicine European public assessment report (EPAR): Kalydeco
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, Revision: 37, Authorised, Last updated: 06/10/2023
age with cystic fibrosis due to several mutations other … age with cystic fibrosis due to several mutations other … levels of chloride in sweat due to CFTR not working properly … -
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Summary of opinion: Rimmyrah (new)
ranibizumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023degeneration, visual impairment due to diabetic macular oedema … retinopathy, visual impairment due to macular oedema secondary … RVO), and visual impairment due to choroidal neovascularisation … -
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,, , , Revision: 6, Authorised, Last updated: 18/09/2023
acid chenodeoxycholic acid due to genetic abnormalities … licensed for this use. However, due to the rarity of the disease … Chenodeoxycholic acid Leadiant due to the rarity of the disease … -
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Human medicine European public assessment report (EPAR): Ristaben
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2010, Revision: 27, Authorised, Last updated: 21/09/2023metformin is inappropriate due to contraindications or intolerance … metformin is inappropriate due to contraindications or intolerance … -
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Human medicine European public assessment report (EPAR): Neparvis
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,, Revision: 18, Authorised, Last updated: 13/09/2023
years with heart failure due to systemic left ventricle … symptomatic heart failure due to systemic left ventricular … years with heart failure due to systemic left ventricle … -
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Veterinary medicine European public assessment report (EPAR): Clevor
ropinirole hydrochloride, Dogs
Date of authorisation: 13/04/2018, Revision: 1, Authorised, Last updated: 07/02/2019blepharospasm (closure of the eyelids due to muscle contraction), short-lived … inhalation pneumonia (lung damage due to content from the stomach … blepharospasm (closure of the eyelids due to muscle contraction), short-lived … -
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Human medicine European public assessment report (EPAR): Cyanokit
hydroxocobalamin, Poisoning
Date of authorisation: 23/11/2007, Revision: 10, Authorised, Last updated: 18/01/2019patients, cyanide poisoning was due to exposure to smoke from … whose cyanide poisoning was due to something other than smoke … whose cyanide exposure was due to something other than smoke …