Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus 1
(HIV 1) infected adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg.
Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm 3, or after failure of protease inhibitor (PI) containing
regimens. Although cross resistance of Efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after
failure of regimens containing Efavirenz.
For a summary of clinical and pharmacodynamic information.
Treatment of essential hypertension.
AMOTAN-H FC TABLET
Add-on therapy
OLMEXA PLUS is indicated in adult patients whose blood pressure is not adequately controlled on the combination of
olmesartan medoxomil and amlodipine taken as dual-component formulation.
Substitution therapy
OLMEXA PLUS is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the
combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (Olmesartan medoxomil and amlodipine or olmesart
Treatment of essential hypertension.
AMOTAN-H FC TABLET
Add-on therapy
OLMEXA PLUS is indicated in adult patients whose blood pressure is not adequately controlled on the combination of
olmesartan medoxomil and amlodipine taken as dual-component formulation.
Substitution therapy
OLMEXA PLUS is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the
combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (Olmesartan medoxomil and amlodipine or olmesart
Treatment of essential hypertension.
AMOTAN-H FC TABLET
Add-on therapy
OLMEXA PLUS is indicated in adult patients whose blood pressure is not adequately controlled on the combination of
olmesartan medoxomil and amlodipine taken as dual-component formulation.
Substitution therapy
OLMEXA PLUS is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the
combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (Olmesartan medoxomil and amlodipine or olmesart
Treatment of essential hypertension.
AMOTAN-H FC TABLET
Add-on therapy
OLMEXA PLUS is indicated in adult patients whose blood pressure is not adequately controlled on the combination of
olmesartan medoxomil and amlodipine taken as dual-component formulation.
Substitution therapy
OLMEXA PLUS is indicated as substitution therapy in adult patients whose blood pressure is adequately controlled on the
combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide, taken as a dual-component (Olmesartan medoxomil and amlodipine or olmesart
Elacestrant Dihydrochloride monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least line of endocrine therapy including a CDK 4/6 inhibitor for at least 12 months.
This indication is approved based on progression free survival. Continued approval of this indication may be contingent upon verification and description of clinical benefit (overall survival) in the confirmatory trials.
Ticagrelor co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with
- acute coronary syndromes (ACS) or
- a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event
Ticagrelor co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with
- acute coronary syndromes (ACS) or
- a history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event
Ticagrelor co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with
- Acute coronary syndromes (ACS) or
- A history of myocardial infarction (MI) and a high risk of developing an atherothrombotic event.
Zylinamet is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
·In patients inadequately controlled on their maximally tolerated dose of metformin alone
·In combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products
·In patients already being treated with the combination of linagliptin and metformin as separate tablets.
