Novartis’ Galvus (vildagliptin) is a member of a new class of oral antidiabetic agents known as dipeptidyl peptidase IV inhibitors (DPP-IV) inhibitors or ‘incretin . Galvus Approval Status. FDA Approved: No Brand name: Galvus Generic name: vildagliptin. Previous Name: LAF Company: Novartis Pharmaceuticals. Vildagliptin is an oral anti-hyperglycemic agent (anti-diabetic drug) of the dipeptidyl The European Medicines Agency has also approved a combination of vildagliptin and metformin, vildagliptin/metformin (Eucreas by Novartis) as an oral.
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It explains how noovartis Committee for Medicinal Products for Human Use CHMP assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Icandra. Icandra is a medicine that contains the active substances vildagliptin and metformin hydrochloride.
The company that makes Eucreas has agreed that its scientific data can be used for Icandra. The recommended dose of Icandra is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Patients already taking vildagliptin and metformin should switch gavlus Icandra containing the same amounts of each active substance.
Doses novzrtis vildagliptin above mg are not recommended. Taking Icandra with or just after food may reduce any stomach problems caused by metformin. Icandra should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver. Elderly patients taking Icandra should have their kidney novartsi monitored regularly. Type-2 diabetes is a disease novaartis which the pancreas does not make enough insulin to control the level of glucose sugar in the blood or when the body is unable to use insulin effectively.
Icandra contains two active substances, which each have a different mode of action. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Vildagliptin does not work when the blood noavrtis is low. Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Galvus 50 mg Tablets
As a result of the action of both substances, the blood glucose is reduced and this helps to control type-2 diabetes. Vildagliptin on its own was approved by the EU in September under the name Galvus, and metformin has been available galvsu the EU since Vildagliptin can be used with metformin in typediabetes patients who are not satisfactorily controlled on metformin alone.
The studies with Galvus as an add-on to metformin, metformin and a sulphonylurea, or metformin and insulin have been used to support the use of Icandra in the same indications. The studies compared Galvus with placebo and measured the levels of a substance in the blood called glycosylated haemoglobin HbA1cwhich gives an indication of how well the blood glucose is controlled.
The applicant also presented the results of two studies showing that the active substances in the two strengths of Icandra were absorbed in the body in the same way as when they were taken as separate tablets. Vildagliptin has been shown to be more effective than placebo a dummy treatment at reducing HbA1c levels when it was added to metformin. Patients adding vildagliptin had a fall in HbA1c levels of 0. In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.
In other studies, vildagliptin in combination with metformin has been shown to be more effective than placebo when used with a sulphonylurea or insulin. The most nogartis side effects with Icandra seen in more than 1 patient in 10 are nausea feeling sickvomiting, diarrhoea, abdominal tummy pain and loss of appetite.
For the full list of galvuw side effects reported with Icandra, see the package leaflet. Icandra should not be used in people who may be hypersensitive allergic to vildagliptin, metformin or any of the other ingredients. It must not be used in patients who have diabetic ketoacidosis high levels of ketones and acids in the blooddiabetic pre-coma, problems with their kidneys or liver, conditions galvuus may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
It must also not be used in patients with alcohol intoxication excessive alcohol consumption or alcoholism, or during breast-feeding. For the full list of restrictions, see the package leaflet.
The CHMP concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment. The CHMP also noted that the combination of vildagliptin and metformin was effective as an add-on to a sulphonylurea or insulin. Therefore, the Committee decided that the benefits of Icandra are greater than its risks and recommended that it be given marketing authorisation.
The name of the medicine was changed to Icandra on 6 February For more information about treatment with Icandra, read the package leaflet also part of the EPAR or contact your doctor or pharmacist.
More detail is available in the summary of product characteristics.
Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
Table of contents Overview Authorisation details Product information Assessment history.
Expand all Collapse all. Icandra is used to treat adults with type-2 diabetes. It is used in the following ways: The medicine can only be obtained with a prescription.
Diabetes Mellitus, Type 2.
Publication details Marketing-authorisation holder Novartis Europharm Limited. You are therefore advised to be selective about which sections or pages you wish to print. Drugs used in diabetes. Combinations of oral blood glucose lowering drugs. Icandra is indicated in the treatment of type-2 diabetes mellitus: Icandra is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Icandra is indicated in combination with a sulphonylurea i. Icandra is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Changes since initial authorisation of medicine List item. Initial marketing-authorisation documents List item. Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function. Investigation into GLPbased diabetes therapies concluded.
Galvus (vildagliptin) FDA Approval Status –
European Medicines Agency investigates findings on pancreatic risks with GLPbased therapies for type-2 diabetes. Metformin and metformin-containing medicines: How useful was this page? Galcus this field blank. International non-proprietary name INN or common name.
Anatomical therapeutic chemical ATC code. Date of issue of marketing authorisation valid throughout the European Union.