1251/17
|
08/02/2021
|
afamelanotide (Scenesse)
|
Full
|
for prevention of photoxicity in adult patients with erythropoietic protoporphyria (EPP). Scenesse is to be administered under a Post-Authorisation Safety Study (PASS) protocol in line with the approved European Medicines Agency Risk Management Plan.
|
|
SMC2280
|
09/11/2020
|
romosozumab (Evenity)
|
Full
|
Treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
|
|
1236/17
|
12/08/2019
|
empaglifozin linagliptin fixed-dose combination (Glyxambi)
|
Abbreviated
|
Indicated in adults aged 18 years and older with type 2 diabetes mellitus: to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control when already being treated with the free combination of empagliflozin and linagliptin
|
|
SMC2180
|
08/07/2019
|
daratumumab (Darzalex)
|
Full
|
In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
|
|
1327/18
|
11/06/2018
|
telotristat (Xermelo)
|
Full
|
for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin anologue (SSA) therapy in adults inadequately controlled by SSA therapy.
|
|
1316/18
|
07/05/2018
|
regorafenib (Stivarga)
|
Full
|
As a monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously tretated with sorafenib
|
|
1315/18
|
07/05/2018
|
avelumab (Bavencio)
|
Full
|
indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC)
|
|
1139/16
|
09/04/2018
|
teduglutide (Revestive)
|
Full
|
Treatment of patients aged 1 year and above with short bowel syndrome.
|
|
1317/18
|
09/04/2018
|
sofosbuvir/velpatasvir/voxilprevir (Vosevi)
|
Full
|
Indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults
|
|
1314/18
|
09/04/2018
|
sarilumab (Kevzara)
|
Full
|
In combination with methotrexate, or as monontherapy, for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs. Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
|
|
1313/18
|
09/04/2018
|
dimethyl fumarate (Skilarence)
|
Full
|
Treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
|
|
1295/18
|
12/03/2018
|
ribociclib (Kisqali)
|
Full
|
for use in combination with an aromatase inhibitor (AI), for the treatment of postmenopausal women with HR+/human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.
|
|
1296/18
|
12/03/2018
|
pembrolizumab (Keytruda)
|
Full
|
monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.
|
|
1297/18
|
12/03/2018
|
atezolizumab (Tecentriq)
|
Full
|
As monotherapy, indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma after prior platinum - containing chemotherapy or who are considered cisplatin ineligible.
|
|
158/05
|
13/11/2017
|
pegvisomant (Somavert)
|
Resubmission
|
Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize insulin-like growth factor type 1 (IGF-1) concentrations or was not tolerated
|
|
1271/17
|
09/10/2017
|
sofosbuvir/velpatasvir (Epclusa)
|
Full
|
Treatment of chronic hepatitis C virus (HCV) infection in adults
|
|
1281/17
|
09/10/2017
|
opicapone (Ongentys)
|
Non submission
|
Adjunctive therapy to preparations of levodopa / DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
|
|
1282/17
|
09/10/2017
|
maraviroc (Celsentri)
|
Non submission
|
In combination with other antiretroviral medicinal products for treatment-experienced adolescents and children of 2 years and older and weighing at least 10kg infected with only CCR5-tropic HIV-1 detectable.
|
|
1205/17
|
09/10/2017
|
daratumumab (Darzalex)
|
Resubmission
|
As monotherapy, for the treatment of adult patients with relapsed and refectory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and have demonstrated disease progression on the last therapy.
|
|
1274/17
|
09/10/2017
|
beclometasone dipropionate anhydrous/formoterol fumarate dihydrate/glycopyrronium bromide (Trimbow)
|
Abbreviated
|
Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.
|
|