12357 results
-
List item
Press release: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity
Last updated: 19/11/2018irbesartan, losartan and olmesartan. The review is being carried … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 2011
CHMP, Last updated: 23/09/2011application/pdf Edarbi azilsartan medoxomil Takeda Global Research and … application/pdf Ipreziv azilsartan medoxomil Takeda Global Research and … -
List item
Press release: PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system
PRAC, Last updated: 11/04/2014eprosartan, irbesartan, losartan, olmesartan, telmisartan or valsartan … eprosartan, irbesartan, losartan, olmesartan, telmisartan or valsartan … -
List item
Press release: European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive
CHMP, Last updated: 20/10/2011eprosartan, irbesartan, losartan, olmesartan, valsartan and telmisartan … eprosartan, irbesartan, losartan, olmesartan, valsartan and telmisartan … eprosartan, irbesartan, losartan, olmesartan, telmisartan and valsartan … -
List item
Press release: EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan: EMA and national authorities considering impact on other active substances produced at the site
Last updated: 28/09/2018irbesartan, losartan and olmesartan. The review is being carried … -
List item
Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 50, Authorised, Last updated: 13/03/2023liver, 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 … -
List item
Human medicine European public assessment report (EPAR): Multaq
dronedarone, Atrial Fibrillation
Date of authorisation: 25/11/2009, Revision: 18, Authorised, Last updated: 25/11/2022only be prescribed after alternative treatment options have been … prolonged ‘QTc Bazett’ (an alteration of the electrical activity … -
List item
Human medicine European public assessment report (EPAR): NovoRapid
insulin aspart, Diabetes Mellitus
Date of authorisation: 07/09/1999, Revision: 32, Authorised, Last updated: 22/03/2023infusion 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 … -
List item
Human medicine European public assessment report (EPAR): Zalasta
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
Human medicine European public assessment report (EPAR): Farydak (updated)
panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015,
, Revision: 12, Authorised, Last updated: 16/05/2023
medical need, it offers a new alternative. Although the side effects … subgroup in view of the lack of alternatives, and could be managed. The … -
List item
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: 8, Authorised, Last updated: 10/11/2022
a poor prognosis and few alternatives. The side effects were similar … -
List item
Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 21-24 June 2010
CHMP, Last updated: 25/06/2010Vpriv might constitute an alternative treatment option for this … Vpriv might constitute an alternative treatment option for this … -
List item
Human medicine European public assessment report (EPAR): Hepsera
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 … -
List item
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 … -
List item
Human medicine European public assessment report (EPAR): Tecartus
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,, , , Revision: 4, Authorised, Last updated: 30/01/2023
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 … -
List item
Human medicine European public assessment report (EPAR): Yescarta
Axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 11, Authorised, Last updated: 30/01/2023
tocilizumab (or a suitable alternative if this is unavailable due … tocilizumab (or a suitable alternative if this is unavailable due … -
List item
Human medicine European public assessment report (EPAR): Zirabev
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 14/02/2019,, , Revision: 12, Authorised, Last updated: 05/01/2023
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
List item
Human medicine European public assessment report (EPAR): Olanzapine Teva
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 29, Authorised, Last updated: 22/11/2022
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 … -
List item
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 … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018
CHMP, Last updated: 21/09/2018irbesartan, losartan and olmesartan. For more information, please … -
List item
Human medicine European public assessment report (EPAR): Xerava (updated)
eravacycline, Infection; Bacterial Infections
Date of authorisation: 20/09/2018,, Revision: 7, Authorised, Last updated: 05/06/2023
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 … -
List item
Human medicine European public assessment report (EPAR): Breyanzi (updated)
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,, Revision: 1, Authorised, Last updated: 25/05/2023
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 …