Malta - English - Medicines Authority

biocon pharma malta limited the victoria centre unit 2 lower ground floor valletta road mosta mst 9012 , malta - hard capsule - dabigatran etexilate 150 mg - antithrombotic agents

Malta - English - Medicines Authority

biocon pharma malta limited the victoria centre unit 2 lower ground floor valletta road mosta mst 9012 , malta - hard capsule - dabigatran etexilate 75 mg - antithrombotic agents

Malta - English - Medicines Authority

biocon pharma malta limited the victoria centre unit 2 lower ground floor valletta road mosta mst 9012 , malta - hard capsule - dabigatran etexilate 110 mg - antithrombotic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

lexon pharmaceuticals (ireland) limited - ivabradine - film-coated tablet - 5 milligram(s) - ivabradine

Ireland - English - HPRA (Health Products Regulatory Authority)

lexon pharmaceuticals (ireland) limited - ivabradine - film-coated tablet - 7.5 milligram(s) - ivabradine

United States - English - NLM (National Library of Medicine)

biocon pharma inc. - fingolimod hydrochloride (unii: g926ec510t) (fingolimod - unii:3qn8byn5qf) - fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. pediatric use information is approved for novartis pharmaceuticals corporation’s gilenya (fingolimod) capsules. however, due to novartis pharmaceuticals corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, tia, decompensated heart failure requiring hospitalization or class iii/iv heart failure - a history or presence of mobitz type ii second-degree or third-degree av block or sick sinus syndrome, unless patient has a functioning pacemaker [see warning and precautions (5.1)] - a baseline qtc interval ≥500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with cla

Singapore - English - HSA (Health Sciences Authority)

zuellig pharma pte. ltd. - pegfilgrastim - injection, solution - pegfilgrastim 6 mg / 0.6 ml

United States - English - NLM (National Library of Medicine)

biocon pharma inc. - teriflunomide (unii: 1c058ikg3b) (teriflunomide - unii:1c058ikg3b) - teriflunomide tablet is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. teriflunomide tablets are contraindicated in/with: - patients with severe hepatic impairment [see warnings and precautions (5.1) ]. - pregnant women and females of reproductive potential not using effective contraception. teriflunomide tablet may cause fetal harm [see warnings and precautions (5.2, 5.3) and use in specific populations (8.1) ]. - patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablet. reactions have included anaphylaxis, angioedema, and serious skin reactions [see warnings and precautions (5.5)]. - coadministration with leflunomide [see clinical pharmacology (12.3)]. risk summary teriflunomide is contraindicated for use in pregnant women and females of reproductive potential

United States - English - NLM (National Library of Medicine)

biocon pharma inc., - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - adults esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed ee in adults. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of esomeprazole magnesium delayed-release capsules may be considered. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of ee in pediatric patients 12 years to 17 years of age. esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of ee in adults. controlled studies do not extend beyond 6 months. adults esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with gerd in adults. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsu

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

mylan pharmaceutical private limited, india - insulin glargine - injection - 100 iu/ml