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.
is a fixed-dose combination product.
is intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products:
• Unstable angina or non-ST elevation myocardial infarction in order to prevent early and long-term
atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischemia).
is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularization (surgical or PCI, with or without stent).
• ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, CLOGREX ASA has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.
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.
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
Bupivacaine Hydrochloride Anhydrous 0.5% is indicated in adults and children of all ages for intrathecal (subarachnoid) spinal anaesthesia for surgery (urological and lower limb surgery lasting 2–3 hours, abdominal
surgery lasting 45–60 minutes).
Bupivacaine Hydrochloride Anhydrous is a long-acting anaesthetic agent of the amide type. Bupivacaine has a rapid onset of action and long duration. The duration of analgesia in the T10–T12 segments is 2–3 hours.
Bupivacaine Hydrochloride Anhydrous produces a moderate muscular relaxation of the lower extremities lasting 2–2.5 hours. The motor blockade of the abdominal muscles makes the solution suitable for performance
of abdominal surgery lasting 45–60 minutes. The duration of the motor blockade does not exceed the duration of analgesia. The cardiovascular effects of bupivacaine are similar or less than those seen with other spinal agents. Bupivacaine is exceptionally well tolerated by all tissues with which it comes in contact.
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.
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.
Rupatadine Fumarate 1 mg/ml oral solution is indicated for the symptomatic treatment of:
-Allergic rhinitis (including persistent allergic rhinitis) in children aged 2 to 11 years.
-Urticaria in children aged 2 to 11 years.
Mepolizumab is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype
Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil is not indicated for use by women.
