10338 results
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Herbal medicinal product: Melaleucae aetheroleum
Melaleuca alternifolia (Maiden and Betche) Cheel, Tea-tree oil, F: Assessment finalised, Last updated: 09/03/2017branches of the trees Melaleuca alternifolia Cheel, M. linariifolia Smith … nity list entry on Melaleuca alternifolia (Maiden and Betch) Cheel … Community list entry on Melaleuca alternifolia (Maiden and Betch) Cheel … -
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Clinical efficacy and safety: blood products (including biotech alternatives)
Last updated: 11/02/2016products (including biotech alternatives) … products (including biotech alternatives) …
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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 … be used as additional or alternative treatment to reduce high … be used as additional or alternative treatment to reduce high … -
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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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CVMP reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU
Last updated: 18/10/2019promoting the authorisation of alternatives to antimicrobials in the EU … promoting the authorisation of alternatives to antimicrobials in the EU …
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Human medicine European public assessment report (EPAR): Farydak
panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015,
, Revision: 9, Authorised, Last updated: 16/06/2020
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: 46, Authorised, Last updated: 21/03/2019liver, 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: 30, Authorised, Last updated: 06/11/2020found 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): Vyxeos liposomal (previously known as Vyxeos)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 4, Authorised, Last updated: 27/01/2021
a poor prognosis and few alternatives. The side effects were similar … -
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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): Xerava
eravacycline, Infection, Bacterial Infections
Date of authorisation: 20/09/2018,
, Revision: 1, Authorised, Last updated: 10/07/2019
shown to be as effective as alternative antibiotics in 2 main studies … Xerava is as effective as alternative antibiotics in treating infections … -
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Human medicine European public assessment report (EPAR): Kigabeq
vigabatrin, Spasms, Infantile, Epilepsies, Partial
Date of authorisation: 20/09/2018, Revision: 3, Authorised, Last updated: 16/09/2020careful assessment of possible alternatives, and patients’ vision must … -
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Human medicine European public assessment report (EPAR): Qutenza
capsaicin, Neuralgia
Date of authorisation: 15/05/2009, Revision: 14, Authorised, Last updated: 21/08/2020helps 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): 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: 2, Authorised, Last updated: 28/08/2019nebuliser, would be a useful alternative. In addition, it takes less … -
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Human medicine European public assessment report (EPAR): Busilvex
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 09/07/2003, Revision: 17, Authorised, Last updated: 20/11/2020either 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): Equidacent
bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,, 
, Revision: 1, Authorised, Last updated: 16/11/2020
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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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): Mvasi
bevacizumab, Carcinoma, Renal Cell, Peritoneal Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Fallopian Tube Neoplasms
Date of authorisation: 15/01/2018,, , Revision: 9, Authorised, Last updated: 03/11/2020
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
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Human medicine European public assessment report (EPAR): Fiasp
insulin aspart, Diabetes Mellitus
Date of authorisation: 09/01/2017,, Revision: 7, Authorised, Last updated: 04/11/2020
infusion under the skin or alternatively, it can be injected into a … -
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Human medicine European public assessment report (EPAR): Effentora
fentanyl, Pain, Cancer
Date of authorisation: 04/04/2008, Revision: 22, Authorised, Last updated: 03/09/2020between the gum and the cheek. Alternatively, the tablets can be placed … between the gum and the cheek. Alternatively, the tablets can be placed … -
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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: 31, Authorised, Last updated: 23/07/2020Tygacil can be a treatment alternative for complicated skin and … -
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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): Olanzapine Teva
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 12/12/2007,
, Revision: 27, Authorised, Last updated: 27/05/2020
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 …