12492 results
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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): Qutenza
capsaicin, Neuralgia
Date of authorisation: 15/05/2009, Revision: 18, Authorised, Last updated: 23/10/2023helps to reduce discomfort. Alternatively, medicines for pain may be … helps to reduce discomfort. Alternatively, medicines for pain may be … -
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Human medicine European public assessment report (EPAR): Vantobra (previously Tobramycin PARI)
Tobramycin, Respiratory Tract Infections; Cystic Fibrosis
Date of authorisation: 18/02/2019, Revision: 5, Authorised, Last updated: 22/09/2023nebuliser, would be a useful alternative. In addition, it takes less … hours. Vantobra is taken in alternating cycles of 28 days. A cycle … is evident, additional or alternative anti-pseudomonal therapy … -
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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): 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): Multaq
dronedarone, Atrial Fibrillation
Date of authorisation: 25/11/2009, Revision: 19, Authorised, Last updated: 27/06/2023only be prescribed after alternative treatment options have been … prolonged ‘QTc Bazett’ (an alteration of the electrical activity … -
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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): 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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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): 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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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): 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): Esbriet
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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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): 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): 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): Abevmy (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: 21/04/2021,, , Revision: 6, Authorised, Last updated: 30/11/2023
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Human medicine European public assessment report (EPAR): Tecartus (updated)
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,, 
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, Revision: 5, Authorised, Last updated: 28/11/2023
tocilizumab (or a suitable alternative if tocilizumab is unavailable … tocilizumab (or a suitable alternative if tocilizumab is unavailable … Tocilizumab or a suitable alternative in case tocilizumab is unavailable … -
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 18, Authorised, Last updated: 24/11/2023
inhibitors and they have no alternative treatment options. Blincyto … inhibitors and they have no alternative treatment options. Blincyto … -
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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): Oyavas (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: 26/03/2021,, , Revision: 6, Authorised, Last updated: 09/11/2023
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Human medicine European public assessment report (EPAR): Yescarta
Axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 12, Authorised, Last updated: 30/10/2023
tocilizumab (or a suitable alternative if this is unavailable due … tocilizumab (or a suitable alternative if this is unavailable due …