11930 results
Keyword Amlodipina Alter Remove keyword
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Herbal medicinal product: Melaleucae aetheroleum
Melaleuca alternifolia (Maiden and Betche) Cheel, Tea-tree oil, F: Assessment finalised, Last updated: 15/03/2022branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … Tea tree oil Melaleuca alternifolia (Maiden and Betch) Cheel … branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … -
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Clinical efficacy and safety: blood products (including biotech alternatives)
Last updated: 11/02/2016products (including biotech alternatives) …
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Promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU
Last updated: 26/07/2021omoting the authorisation of alternatives to antimicrobial veterinary … ‘Promoting the authorisation of alternatives to antimicrobial veterinary … promote the authorisation of alternatives to antimicrobials in the …
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Press release: Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels
CMDh, Last updated: 20/12/2013be used as additional or alternative treatment to reduce high … only as an additional or alternative treatment in type IIb and … role as an additional or alternative treatment to reduce triglycerides … -
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Press release: PRAC recommends using acipimox only as additional or alternative treatment to lower high triglyceride levels
PRAC, Last updated: 08/11/2013acipimox only as additional or alternative treatment to lower high triglyceride … acipimox only as additional or alternative treatment to lower high triglyceride … acipimox only as additional or alternative treatment to lower high triglyceride … -
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Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products
Last updated: 23/04/2009rabbit pyrogen testing by an alternative test for plasma derived medicinal … rabbit pyrogen testing by an alternative test for plasma derived medicinal …
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Human medicine European public assessment report (EPAR): Farydak
panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015,, Revision: 11, Authorised, Last updated: 05/04/2022
medical need, it offers a new alternative. Although the side effects … subgroup in view of the lack of alternatives, and could be managed. The … -
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Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 48, Authorised, Last updated: 25/11/2021liver, QT prolongation (an alteration of the electrical activity … another type of heart activity alteration); midazolam taken by mouth … electrocardiogram (ECG). These indicate alterations of the electrical activity … -
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Human medicine European public assessment report (EPAR): Torisel
Temsirolimus, Carcinoma, Renal Cell; Lymphoma, Mantle-Cell
Date of authorisation: 19/11/2007, Revision: 33, Authorised, Last updated: 21/06/2022found more effective than alternative cancer medicines (such as … Torisel or the most appropriate alternative cancer medicines chosen by … months in those receiving the alternative treatment. What are the risks … -
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,,
, Revision: 3, Withdrawn, Last updated: 25/11/2021
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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Human medicine European public assessment report (EPAR): Xerava
eravacycline, Infection; Bacterial Infections
Date of authorisation: 20/09/2018,, Revision: 4, Authorised, Last updated: 19/08/2021
shown 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): Lumykras
sotorasib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 06/01/2022,, Authorised, Last updated: 31/03/2022
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): Kirsty (previously Kixelle)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,,
, Revision: 1, Authorised, Last updated: 14/09/2021
infusion under the skin or alternatively, it can be given into a vein … infusion under the skin or alternatively, it can be given into a vein … -
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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: 3, Authorised, Last updated: 06/07/2022
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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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: 18/01/2019seen with Cyanokit and with alternatives. However, the CHMP concluded … Cyanokit had advantages over alternative antidotes because it has … seen with Cyanokit and with alternatives. However, the CHMP concluded … -
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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: 3, Authorised, Last updated: 13/04/2021nebuliser, 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): Breyanzi
CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022,, Authorised, Last updated: 20/05/2022
tocilizumab (or a suitable alternative if this is unavailable due … Tocilizumab, or suitable alternatives in case of its unavailability … tocilizumab (or a suitable alternative if this is unavailable due … -
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Human medicine European public assessment report (EPAR): NovoRapid
insulin aspart, Diabetes Mellitus
Date of authorisation: 07/09/1999, Revision: 31, Authorised, Last updated: 23/11/2020infusion under the skin or alternatively, it can be given into a vein … infusion under the skin or alternatively, it can be given into a vein … -
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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: 09/02/2022either 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): 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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Veterinary medicine European public assessment report (EPAR): Pexion
imepitoin, Dogs
Date of authorisation: 25/02/2013, Revision: 6, Authorised, Last updated: 15/08/2018after careful evaluation of alternative treatment options; reduce … after careful evaluation of alternative treatment options; • … after careful evaluation of alternative treatment options. For … -
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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): Tygacil
Tigecycline, Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections
Date of authorisation: 24/04/2006, Revision: 33, Authorised, Last updated: 26/10/2021Tygacil can be a treatment alternative for complicated skin and … -
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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 …