12168 results
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Human medicine European public assessment report (EPAR): Xerava
eravacycline, Infection; Bacterial Infections
Date of authorisation: 20/09/2018, Revision: 7, Authorised, Last updated: 22/06/2023shown to be as effective as alternative antibiotics in 2 main studies … Xerava is as effective as alternative antibiotics in treating infections … measures should be taken and alternative antimicrobial treatment should … -
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Human medicine European public assessment report (EPAR): Fiasp
insulin aspart, Diabetes Mellitus
Date of authorisation: 09/01/2017, Revision: 8, Authorised, Last updated: 23/09/2021infusion under the skin or alternatively, it can be injected into a … -
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PRAC members
Last updated: 02/07/2012details of the members and alternates of its Pharmacovigilance … details of the members and alternates of its Pharmacovigilance …
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Human medicine European public assessment report (EPAR): Sebivo
telbivudine, Hepatitis B, Chronic
Date of authorisation: 24/04/2007, Revision: 20, Withdrawn, Last updated: 14/01/2021considered when the use of an alternative antiviral agent with a higher … or appropriate to use an alternative medicine which the hepatitis … -
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Human medicine European public assessment report (EPAR): Aybintio
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020,
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, Revision: 7, Authorised, Last updated: 11/04/2023
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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Human medicine European public assessment report (EPAR): Esbriet (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 27/02/2011, Revision: 33, Authorised, Last updated: 08/09/2023noted the lack of effective alternative treatments. It was therefore … noted the lack of effective alternative treatments. It was therefore … -
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CAT members
Last updated: 31/12/2009details of the members and alternates of its … details of the members and alternates of its …
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Human medicine European public assessment report (EPAR): Avastin
bevacizumab, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Ovarian Neoplasms; Colorectal Neoplasms; Carcinoma, Renal Cell
Date of authorisation: 12/01/2005, Revision: 63, Authorised, Last updated: 17/03/2023paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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Human medicine European public assessment report (EPAR): Fetcroja
cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections
Date of authorisation: 23/04/2020,, Revision: 5, Authorised, Last updated: 08/03/2023
those treated with the best alternative treatment. For bloodstream … patients receiving the best alternative treatment. What are the risks … function (see section 4.2). Alternatively, cefiderocol should be discontinued … -
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Human medicine European public assessment report (EPAR): Lytgobi
Futibatinib, Cholangiocarcinoma
Date of authorisation: 04/07/2023,, 
, Authorised, Last updated: 18/07/2023
treatment. All patients had alterations (changes) in the FGFR2 gene … therapy and who had FGFR2 alterations. Treatment with Lytgobi resulted … treatment. All patients had alterations (changes) in the FGFR2 gene … -
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Summary of opinion: Krazati
adagrasib, opinion date: 20/07/2023, Negative, Last updated: 28/07/2023gene can produce an altered protein that causes the uncontrolled … adagrasib, attaches to this altered protein inside cancer cells … KRAS gene can produce an altered protein that causes the uncontrolled … -
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Human medicine European public assessment report (EPAR): Ketek
telithromycin, Sinusitis; Tonsillitis; Bronchitis, Chronic; Pharyngitis; Community-Acquired Infections; Pneumonia, Bacterial
Date of authorisation: 09/07/2001, Revision: 25, Withdrawn, Last updated: 19/06/2019as an alternative when beta-lactam antibiotics … -
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PDCO members
Last updated: 31/12/2009details of the members and alternates of its … details of the members and alternates of its …
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Human medicine European public assessment report (EPAR): Vibativ
telavancin, Pneumonia, Bacterial; Cross Infection
Date of authorisation: 02/09/2011,, Revision: 10, Withdrawn, Last updated: 16/05/2018
known or suspected that other alternatives are not suitable. Consideration … marketing authorisations as alternative suppliers or formulations … patients’ needs and for which no alternative supplier or formulation is … -
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Press release: Combined use of medicines affecting the renin-angiotensin system (RAS) to be restricted – CHMP endorses PRAC recommendation
CHMP, Last updated: 23/05/2014eprosartan, irbesartan, losartan, olmesartan, telmisartan or valsartan … -
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Human medicine European public assessment report (EPAR): Lumykras
sotorasib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/01/2022,, , Revision: 1, Authorised, Last updated: 29/11/2022
KRAS gene can produce an altered protein that causes the uncontrolled … sotorasib, attaches to this altered protein inside cancer cells … KRAS gene can produce an altered protein that causes the uncontrolled … -
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Human medicine European public assessment report (EPAR): Quofenix
delafloxacin meglumine, Community-Acquired Infections
Date of authorisation: 16/12/2019,, Revision: 5, Authorised, Last updated: 13/10/2022
shown to be as effective as alternative antibiotics in two main studies … Quofenix is as effective as alternative antibiotics given into a … shown to be as effective as alternative antibiotics in two main studies … -
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Human medicine European public assessment report (EPAR): Levviax
telithromycin, Community-Acquired Infections; Pharyngitis; Bronchitis, Chronic; Pneumonia; Tonsillitis; Sinusitis
Date of authorisation: 09/07/2001, Revision: 10, Withdrawn, Last updated: 14/02/2008Streptococcus pyogenes, as an alternative when beta lactam antibiotics … Streptococcus pyogenes, as an alternative when beta lactam antibiotics … beta streptococci, as an alternative when beta lactam antibiotics … -
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Veterinary medicine European public assessment report (EPAR): Improvac
Synthetic peptide analogue of GnRF conjugated to diptheria toxoid, Male pigs (from 8 weeks of age); Female pigs (from 14 weeks of age)
Date of authorisation: 11/05/2009, Revision: 20, Authorised, Last updated: 05/04/2022animals. Improvac is used as an alternative to physical castration (removal … animals. Improvac is used as an alternative to physical castration (removal … -
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Human medicine European public assessment report (EPAR): Olanzapine Teva (updated)
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007,
, Revision: 30, Authorised, Last updated: 25/09/2023
a mental illness causing alternating periods of high mood and … tablets, which can be used as an alternative to the tablets, are taken … a mental illness causing alternating periods of high mood and … -
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Human medicine European public assessment report (EPAR): Levetiracetam Sun (updated)
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 19, Authorised, Last updated: 22/09/2023
Levetiracetam Sun is used as an alternative for patients when oral treatment … Levetiracetam Sun is used as an alternative for patients when oral treatment … -
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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
retrovirus, which has been altered genetically so that it can … appropriate bone marrow donor and alternative treatment had not worked … retrovirus, which has been altered genetically so that it can … -
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Human medicine European public assessment report (EPAR): Olanzapine Apotex
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 10/06/2010,, Revision: 13, Authorised, Last updated: 09/03/2023
disorder (a mental illness with alternating periods of high mood and … disorder (a mental illness with alternating periods of high mood and … -
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Human medicine European public assessment report (EPAR): Vegzelma (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 17/08/2022,, , Revision: 4, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Odefsey
emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/06/2016, Revision: 20, Authorised, Last updated: 20/02/2023considered that Odefsey is an alternative treatment option to Eviplera … considered that Odefsey is an alternative treatment option to Eviplera …