Type 2 diabetes mellitus
Dapagliflozin is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.
-as monotherapy when metformin is considered inappropriate due to intolerance.
-in addition to other medicinal products for the treatment of type 2 diabetes.
Heart failure
Dapagliflozin is indicated in adults for the treatment of symptomatic chronic heart failure.
Chronic kidney disease
Dapagliflozin is indicated in adults for the treatment of chronic kidney disease.
For adult patients with type 2 diabetes mellitus:
as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.
as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Acyclovir is indicated for the treatment of Herpes Simplex virus
infections of the skin including initial and recurrent genital herpes and herpes labialis.
The treatment of the following infections:
1. As part of a multidrug regimen in the treatment of all forms of leprosy.
2. Treatment of blistering dermatoses such as dermatitis herpetiformis.
3. Prophylaxis of Pneumocystis jirovecii pneumonia in immunodeficient subjects, especially AIDS patients.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Adults
Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight.
Paediatric population
Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus erythematosus.
Deferasirox is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.
Deferasirox is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:
- in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,
- in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (<7 ml/kg/month of packed red blood cells) aged 2 years and older,
- in adult and paediatric patients with other anaemias aged 2 years and older.
Deferasirox is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with nontransfusion-dependent thalassaemia syndromes aged 10 years and older.
Denosumab is intended for the following indications:
• Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women it significantly reduces the risk of vertebral, non-vertebral and hip fractures.
• Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, it significantly reduces the risk of vertebral fractures.
• Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
