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.
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.
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.
Malignant pleural mesothelioma
Pemetrexed Disodium in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Disodium in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
Pemetrexed Disodium is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.
Pemetrexed Disodium is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
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.