8063 results
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Direct healthcare professional communication (DHPC): Champix (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the Pfizer acceptable daily intake limit
Active substance: varenicline, DHPC type: Quality defect, Last updated: 15/07/2021varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline … varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline … varenicline) - lots to be recalled due to presence of impurity … -
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Direct healthcare professional communication (DHPC): Nulojix (belatacept): Risk of medication errors due to change in maintenance dose from 5 mg/kg to 6 mg/kg
Active substance: belatacept, DHPC type: Medication error, Last updated: 12/09/2022Risk of medication errors due to change in maintenance … Risk of medication errors due to change in maintenance … Risk of medication errors due to change in maintenance … -
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Direct healthcare professional communication (DHPC): Imbruvica (ibrutinib): New risk minimisation measures, including dose modification recommendations, due to the increased risk for serious cardiac events
Active substance: Ibrutinib, DHPC type: Post-authorisation measure, Last updated: 03/11/2022modification recommendations, due to the increased risk for … modification recommendations, due to the increased risk for … modification recommendations, due to the increased risk for … -
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Direct healthcare professional communication (DHPC): Insuman Implantable 400 IU/ml insulin solution for infusion: no new patients should be started due to discontinuation of MiniMed Implantable Pump
Active substance: insulin human, DHPC type: Type II variation, Last updated: 21/07/2020patients should be started due to discontinuation of MiniMed … patients should be started due to discontinuation of MiniMed … -
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Assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals - Scientific guideline
Last updated: 04/03/2015antimicrobial resistance due to the use of an antimicrobial … antimicrobial resistance due to the use of an antimicrobial … antimicrobial resistance due to the use of an 5 antimicrobial …
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Press release: Update on medicines containing valsartan from Zhejiang Tianyu: company no longer authorised to manufacture valsartan active substance for EU medicines due to presence of NDMA
Last updated: 20/08/2018substance for EU medicines due to presence of NDMA … substance for EU medicines due to presence of NDMA The … substance for EU medicines due to presence of NDMA The … -
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Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium Tuberculosis - Scientific guideline
Last updated: 01/02/2018new agents to treat disease due to Mycobacterium Tuberculosis … new agents to treat disease due to Mycobacterium Tuberculosis … to treat pulmonary disease due to Mycobacterium tuberculosis …
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Veterinary medicine European public assessment report (EPAR): Nobivac Myxo-RHD (updated)
live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009, Rabbits
Date of authorisation: 07/09/2011, Revision: 4, Withdrawn, Last updated: 12/09/2023deaths and clinical signs due to myxomatosis (skin tumours … virus) and to prevent death due to RHD, a disease resulting … deaths and clinical signs due to myxomatosis and prevent … -
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Veterinary medicine European public assessment report (EPAR): Vectormune FP ILT
recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus, live, Chicken
Date of authorisation: 09/12/2020, Authorised, Last updated: 10/09/2021chickens to reduce skin lesions due to fowlpox (FP) and to reduce … tracheal (windpipe) lesions due to avian infectious laryngotracheitis … signs and tracheal damage due to ILT virus. A number of … -
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Human medicine European public assessment report (EPAR): Eylea (updated)
aflibercept, Wet Macular Degeneration; Macular Edema; Diabetes Complications
Date of authorisation: 21/11/2012, Revision: 30, Authorised, Last updated: 13/09/2023swelling; impaired vision due to macular oedema (swelling … occlusion, BRVO); impaired vision due to macular oedema caused … diabetes; impaired vision due to myopic choroidal neovascularisation … -
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Human medicine European public assessment report (EPAR): Rivastigmine Sandoz
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 10/12/2009, Revision: 14, 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): Rivastigmine 1 A Pharma
rivastigmine, Alzheimer Disease; Dementia; 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): Corlentor
ivabradine hydrochloride, Angina Pectoris; Heart Failure
Date of authorisation: 25/10/2005, Revision: 26, Authorised, Last updated: 17/12/2021reduction in the risk of death due to heart problems and non-fatal … reduction in the risk of death due to heart problems and non-fatal … placebo at preventing death due to disease of the heart or … -
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Human medicine European public assessment report (EPAR): Lucentis
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetes Complications; Myopia, Degenerative
Date of authorisation: 22/01/2007, Revision: 42, Authorised, Last updated: 17/05/2023Macular 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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Veterinary medicine European public assessment report (EPAR): Vectormune FP ILT + AE
live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rFP-LT) and avian encephalomyelitis virus, strain Calnek 1143 (AE), Chicken
Date of authorisation: 24/04/2020, Revision: 1, Authorised, Last updated: 09/09/2020chickens to reduce skin damage due to fowlpox (FP), to reduce … tracheal (windpipe) damage due to avian infectious laryngotracheitis … prevent loss of egg production due to avian encephalomyelitis … -
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Human medicine European public assessment report (EPAR): Exjade
deferasirox, beta-Thalassemia; Iron Overload
Date of authorisation: 28/08/2006,
, Revision: 51, Authorised, Last updated: 22/12/2022
In chronic iron overload due to blood transfusions, one … -
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Veterinary medicine European public assessment report (EPAR): Halocur
halofuginone, Calves, newborn
Date of authorisation: 29/10/1999, Revision: 9, Authorised, Last updated: 23/02/2021effective at preventing diarrhoea due to … effective at preventing diarrhoea due to C. parvum. Early treatment … effective at preventing diarrhoea due to C. parvum. Early treatment … -
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Human medicine European public assessment report (EPAR): Hyftor
Sirolimus, Angiofibroma; Tuberous Sclerosis
Date of authorisation: 15/05/2023,
, Revision: 1, Authorised, Last updated: 29/06/2023
works in facial angiofibroma due to tuberous sclerosis complex … works in facial angiofibroma due to tuberous sclerosis complex … with facial angiofibroma due to tuberous sclerosis complex … -
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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): Procoralan
ivabradine hydrochloride, Angina Pectoris; Heart Failure
Date of authorisation: 25/10/2005, Revision: 22, Authorised, Last updated: 17/12/2021reduction in the risk of death due to heart problems and non-fatal … -
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Human medicine European public assessment report (EPAR): Strimvelis (updated)
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): 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): 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): 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 …