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Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease (see section 5.1).

ORALDENE is indicated for use in minor mouth infections including thrush, as an aid in the prevention and treatment of gingivitis, and in the management of sore throat and recurrent aphthous ulcers. ORALDENE is also of value in the alleviation of halitosis and pre- and post-dental surgery.

Rheumatoid arthritis ORENCIA, in combination with methotrexate, is indicated for: ▪ the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. ▪ the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate. Psoriatic arthritis ORENCIA, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate and for whom additional systemic therapy for psoriatic skin lesions is not required.

Rheumatoid arthritis ORENCIA, in combination with methotrexate, is indicated for: ▪ the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. ▪ the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate. Psoriatic arthritis ORENCIA, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required. Polyarticular juvenile idiopathic arthritis ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 6 years of age and older who have had an inadequate response to previous DMARD therapy. ORENCIA can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.

For moderate to severe pain.

For moderate to severe pain.

MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile (see sections 4.3 and 4.4), MULTAQ should only be prescribed after alternative treatment options have been considered. MULTAQ must not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.

Omeprazole Oral Suspension is indicated for: Adults • Treatment of duodenal ulcers • Prevention of relapse of duodenal ulcers • Treatment of gastric ulcers • Prevention of relapse of gastric ulcers • In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease • Treatment of NSAID-associated gastric and duodenal ulcers • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk • Treatment of reflux esophagitis • Long-term management of patients with healed reflux esophagitis • Treatment of symptomatic gastro-esophageal reflux disease Paediatric use Children over 1 month of age • Treatment of reflux esophagitis • Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease Children over 4 years of age and adolescents In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori

Omeprazole for intravenous use is indicated in adults, as an alternative to oral therapy, for the following indications: • Treatment of duodenal ulcers • Prevention of relapse of duodenal ulcers • Treatment of gastric ulcers • Prevention of relapse of gastric ulcers • In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease • Treatment of NSAID-associated gastric and duodenal ulcers • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk • Treatment of reflux esophagitis • Long-term management of patients with healed reflux esophagitis • Treatment of symptomatic gastro-esophageal reflux disease • Treatment of Zollinger-Ellison syndrome

Adults: Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy Ondansetron is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV). Paediatric Population: Ondansetron is indicated for the management of chemotherapy-induced nausea and vomiting in children aged ≥6 months, and for the prevention and treatment of post-operative nausea and vomiting in children aged ≥ 1 month.