12297 results
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Human medicine European public assessment report (EPAR): Ameluz
5-aminolevulinic acid hydrochloride, Keratosis, Actinic; Carcinoma, Basal Cell
Date of authorisation: 13/12/2011, Revision: 19, Authorised, Last updated: 23/03/2022somewhat safer than the standard alternative. The Agency therefore concluded … -
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Human medicine European public assessment report (EPAR): Busilvex
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 09/07/2003, Revision: 19, Authorised, Last updated: 01/02/2022either cyclophosphamide or an alternative medicine, melphalan, in children … Busilvex also provides an alternative to busulfan tablets, which … marketing authorisations as alternative suppliers or formulations … -
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Human medicine European public assessment report (EPAR): Fetcroja (updated)
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): Duavive
oestrogens conjugated, bazedoxifene, Postmenopause
Date of authorisation: 16/12/2014, Revision: 14, Authorised, Last updated: 21/01/2022smaller than what is seen with alternative treatments (progestogen-containing … women who cannot take these alternative medicines. Regarding safety … smaller than what is seen with alternative treatments (progestogen-containing … -
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Human medicine European public assessment report (EPAR): Zalasta (updated)
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 27/09/2007,, Revision: 20, Authorised, Last updated: 22/02/2023
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): Zoledronic Acid Hospira
zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012,, Revision: 18, Authorised, Last updated: 09/11/2021
process of bone growth is altered, which causes bones to become … process of bone growth is altered, which causes bones to become … -
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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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Human medicine European public assessment report (EPAR): Eurartesim
piperaquine tetraphosphate, Artenimol, Malaria
Date of authorisation: 27/10/2011, Revision: 12, Authorised, Last updated: 01/09/2021interval prolongation (an alteration of the electrical activity … treatment by offering a new alternative artemisinin combination therapy … interval prolongation (an alteration of the electrical activity … -
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Human medicine European public assessment report (EPAR): Onbevzi
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: 11/01/2021,,
, Revision: 3, Authorised, Last updated: 05/01/2023
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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Human medicine European public assessment report (EPAR): Oyavas
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: 26/03/2021,,
, Revision: 4, Authorised, Last updated: 05/01/2023
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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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): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,,
, Revision: 4, Authorised, Last updated: 15/12/2022
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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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,,
, Revision: 6, Authorised, Last updated: 15/12/2022
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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Human medicine European public assessment report (EPAR): Abevmy
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: 21/04/2021,,
, Revision: 5, Authorised, Last updated: 15/12/2022
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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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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Human medicine European public assessment report (EPAR): Trulicity (updated)
dulaglutide, Diabetes Mellitus, Type 2
Date of authorisation: 21/11/2014, Revision: 17, Authorised, Last updated: 16/03/2023achieving this target with alternative treatments. A further study … achieving this target with alternative treatments. A further study … -
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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): Tygacil
Tigecycline, Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections
Date of authorisation: 24/04/2006, Revision: 34, Authorised, Last updated: 11/10/2022Tygacil can be a treatment alternative for complicated skin and … -
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Human medicine European public assessment report (EPAR): Hepsera (updated)
adefovir dipivoxil, Hepatitis B, Chronic
Date of authorisation: 06/03/2003, Revision: 27, Withdrawn, Last updated: 06/03/2023considered when the use of an alternative antiviral agent with a higher … -
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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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Human medicine European public assessment report (EPAR): Zavicefta
avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections
Date of authorisation: 23/06/2016,, Revision: 14, Authorised, Last updated: 05/07/2022
infection) was as effective as alternative antibiotics: 91% of patients … after treatment with the best alternative antibiotic. In addition … after treatment with the best alternative antibiotic. These results … -
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Human medicine European public assessment report (EPAR): Tabrecta
capmatinib dihydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/06/2022,, Revision: 1, Authorised, Last updated: 25/01/2023
cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial … cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial … -
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Human medicine European public assessment report (EPAR): Cresemba
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 15, Authorised, Last updated: 17/01/2023
mucormycosis, there is a need for alternative treatments and Cresemba will … mucormycosis, there is a need for alternative treatments and Cresemba … -
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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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Human medicine European public assessment report (EPAR): Levetiracetam Hospira
levetiracetam, Epilepsy
Date of authorisation: 07/01/2014,, Revision: 23, Authorised, Last updated: 15/06/2022
Levetiracetam Hospira is used as an alternative for patients when oral treatment … Levetiracetam Hospira is used as an alternative for patients when oral treatment …