For the treatment of adult patients with immune (idiopathic) thrombocytopenic purpura (ITP) lasting at least 6 months from diagnosis who have not responded sufficiently to other treatment options (e.g.Corticosteroids, immunoglobulins or splenectomy) when there is an increased risk of bleeding due to pronounced thrombocytopenia.
For the treatment of paediatric patients (aged 1 year and older) with immune (idiopathic) thrombocytopenic purpura (ITP) lasting at least 6 months from diagnosis and a significant tendency to bleed who have not responded to an established treatment (e.g. IVIG, corticosteroids) and for whom splenectomy is not a treatment option.
For the treatment of thrombocytopenia in adult patients aged 18 years and older with chronic hepatitis C virus (HCV) infection, where the degree of thrombocytopenia prevents the initiation of interferon-based therapy and/or the ability to optimally maintain it. Ropirage has not been tested in combination with HCV protease inhibitors (boceprevir, telaprevir).
For the treatment of cytopenias in adult patients with acquired severe aplastic anaemia (SAA) who are either treatment-refractory or who have undergone considerable prior therapy and who are not eligible for a haematopoietic stem cell transplant at the time of indication.
For the first-line treatment of acquired severe aplastic anaemia (SAA) in combination with standard immunosuppressive therapy in adult and paediatric patients aged 2 years and over who are unsuitable for haematopoietic stem cell transplantation at the time of diagnosis.
Treatment of essential hypertension in adults and in children and adolescents 6 – 18 years of age.
· Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥ 0.5 g/day as part of an antihypertensive treatment
· Reduction in the risk of stroke in adult hypertensive patients with left ventricular hypertrophy documented by ECG.
Treatment of bleeding oesophageal varices.
Emergency treatment of type 1 hepatorenal syndrome, as defined by IAC (International Ascites Club) criteria.
Pantoprazole is indicated for use in adults and adolescents 12 years of age and above for:
- Reflux oesophagitis.
Pantoprazole is indicated in adults for:
- Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers.
- Gastric and duodenal ulcer.
- Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as:
monotherapy
• When metformin is inappropriate due to intolerance, or contraindicated due to renal impairment. combination therapy
• in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control
Lacosamide is indicated as monotherapy in the treatment of partial- seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epi-lepsy.
Lacosamide is indicated as adjunctive therapy
• in the treatment of partial- seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
• in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
For adult patients with type 2 diabetes mellitus, Sitaglu is indicated to improve glycaemic control:
as monotherapy:
• in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
as dual oral therapy in combination with:
• metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e. a thiazolidinedione) when use of a PPARγ agonist is appropriate and when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control
as triple oral therapy in combination with:
• a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• a PPARγ agonist and metformin when use of a PPARγ agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Sitagliptin is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Malignant pleural mesothelioma
-Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
-Pemetrexed 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 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 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.
-Pemetrexed is indicated in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous
NSCLC (non-small cell lung cancer), with no EGFR (Epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase) genomic tumor aberrations
Adults:
Major depressive episodes.
Obsessive-compulsive disorder.
Bulimia nervosa: Fluoxetine is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity.
Children and Adolescents Aged 8 Years and Above:
Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.
