12269 results
Keyword Sildenafil Alter Remove keyword
-
List item
Orphan designation: tacrolimus for: Treatment of pulmonary arterial hypertension
Date of designation: 23/08/2017, Positive, Last updated: 17/10/2017iloprost, macitentan, riociguat, sildenafil, tadalafil and treprostinil … condition; the existence of alternative methods of diagnosis, prevention … iloprost, macitentan, riociguat, sildenafil, tadalafil and treprostinil … -
List item
Orphan designation: Sodium nitrite for: Treatment of pulmonary arterial hypertension
Date of designation: 05/03/2012, Positive, Last updated: 06/07/2012bosentan, epoprostenol, iloprost, sildenafil, tadalafil and treprostinil … condition; the existence of alternative methods of diagnosis, prevention … bosentan, epoprostenol, iloprost, sildenafil, tadalafil and treprostinil … -
List item
Press release: Update on the withdrawal of Thelin
CHMP, Last updated: 16/12/2010Prescribers should choose alternatives in line with treatment guidel … Prescribers should choose alternatives in line with treatment guidelines … Committee has also considered alternative treatment options. The … -
List item
Orphan designation: Macitentan for: Treatment of pulmonary arterial hypertension
Date of designation: 27/09/2011, Positive, Last updated: 12/10/2018bosentan, ambrisentan, tadalafil, sildenafil, iloprost, epoprostenol, and … bosentan, ambrisentan, tadalafil, sildenafil, iloprost, epoprostenol … condition; • the existence of alternative methods of diagnosis, prevention … -
List item
News: Public Statement on Viagra and Patrex
CHMP, Last updated: 22/04/1999pharmacokinetics of saquinavir and sildenafil and ritonavir and sildenafil when co-administered to healthy … steady state (500 mg bid) with sildenafil (100 mg single dose) resulted … pharmacokinetics of saquinavir and sildenafil and ritonavir and sildenafil when co-administered to healthy … -
List item
Orphan designation: (S)-3-((3-(1-((6-(3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium (seralutinib) for: Treatment of pulmonary arterial hypertension
Date of designation: 29/05/2019, Positive, Last updated: 30/09/2022macitentan, riociguat, selexipag, sildenafil, tadalafil and treprostinil … condition; the existence of alternative methods of diagnosis, prevention … -
List item
Orphan designation: sotatercept for: Treatment of pulmonary arterial hypertension
Date of designation: 09/12/2020, Positive, Last updated: 26/04/2022macitentan, riociguat, selexipag, sildenafil, tadalafil and treprostinil … macitentan, riociguat, selexipag, sildenafil, tadalafil and treprostinil … condition; • the existence of alternative methods of diagnosis, prevention … -
List item
Orphan designation: Ralinepag for: Treatment of pulmonary arterial hypertension
Date of designation: 11/01/2019, Positive, Last updated: 16/07/2021macitentan, riociguat, selexipag, sildenafil, tadalafil and treprostinil … condition; the existence of alternative methods of diagnosis, prevention … -
List item
Human medicine European public assessment report (EPAR): Reyataz
atazanavir (as sulfate), HIV Infections
Date of authorisation: 01/03/2004, Revision: 53, Authorised, Last updated: 17/10/2022used to treat tuberculosis), sildenafil (when this medicine is used … used to treat tuberculosis), sildenafil (when this medicine is used … -
List item
Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 49, Authorised, Last updated: 20/10/2022liver, 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): Rybrevant (updated)
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,
, 
, Revision: 2, Authorised, Last updated: 30/11/2023
-
List item
National expert: Karel Allegaert, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 85.83 KB | PDF
- Curriculum Vitae - 16.75 KB | PDF
neonates) 01/2014-10/2015 Pfizer sildenafil pulmonary hypertension of … 4 09/2013-01/2014 Pfizer sildenafil (iv) (switched to PI, cfr … Therapies (CAT) member or alternate Not a CAT member or … -
List item
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 … -
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): 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): 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
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
National expert: Sabine Straus, Medicines Evaluation Board (updated)
- Declaration of interests - 80.42 KB | PDF
- Curriculum Vitae - 33.81 KB | PDF
Silva D, Janssen H, Raine J, Alteri E. Study Design and Evaluation … Therapies (CAT) member or alternate Not a CAT member or alternate CONFIDENTIALITY UNDERTAKING In … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
CHMP, Last updated: 17/09/2021Sildenafil FGK … -
List item
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 … -
List item
Human medicine European public assessment report (EPAR): Carvykti (updated)
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 1, Authorised, Last updated: 17/01/2023
tocilizumab (or a suitable alternative when tocilizumab is unavailable … Tocilizumab, or suitable alternatives in case of its unavailability … tocilizumab (or a suitable alternative when tocilizumab is unavailable … -
List item
Human medicine European public assessment report (EPAR): Mvasi (updated)
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: 14, Authorised, Last updated: 05/01/2023
paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan … -
List item
Human medicine European public assessment report (EPAR): Zirabev (updated)
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): Rubraca
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,
, , Revision: 11, Authorised, Last updated: 08/12/2022
normal cells there is an alternative mechanism for repairing DNA … for repairing DNA but this alternative mechanism does not work properly … origination, pathogenesis, molecular alterations, risk factors, and prognosis …