Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - atorvastatin calcium trihydrate, quantity: 10.85 mg (equivalent: atorvastatin, qty 10 mg); amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg) - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; calcium carbonate; magnesium stearate; pregelatinised maize starch; polysorbate 80; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000 - caduet (amlodipine and atorvastatin) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented. the indications for amlodipine are: 1. hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor. 2. angina: amlodipine is indicated for the first line treatment of chronic stable angina. amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs. the indications for atorvastatin are: 1. atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated. 2. atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, solution - excipient ingredients: water for injections; sodium hydroxide; metacresol; hydrochloric acid; glycerol - other conditions: refrigerate - do not freeze. indications: for the treatment of insulin dependent diabetic patients.

Malta - angličtina - Medicines Authority

galenicum health, s.l.u calle sant gabriel, 50 esplugues de llobregat 08950 barcelona, spain - rosuvastatin - film-coated tablet - rosuvastatin 5 mg - lipid modifying agents

Malta - angličtina - Medicines Authority

galenicum health, s.l.u calle sant gabriel, 50 esplugues de llobregat 08950 barcelona, spain - rosuvastatin - film-coated tablet - rosuvastatin 10 mg - lipid modifying agents

Malta - angličtina - Medicines Authority

galenicum health, s.l.u calle sant gabriel, 50 esplugues de llobregat 08950 barcelona, spain - rosuvastatin - film-coated tablet - rosuvastatin 20 mg - lipid modifying agents

Malta - angličtina - Medicines Authority

galenicum health, s.l.u calle sant gabriel, 50 esplugues de llobregat 08950 barcelona, spain - rosuvastatin - film-coated tablet - rosuvastatin 40 mg - lipid modifying agents

Európska únia - angličtina - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - pegfilgrastim - neutropenia - immunostimulants, - reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Európska únia - angličtina - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - adalimumab - hidradenitis suppurativa; psoriasis; uveitis; arthritis, rheumatoid; spondylitis, ankylosing; crohn disease; colitis, ulcerative; arthritis, psoriatic - immunosuppressants, tumor necrosis factor alpha (tnf-α) inhibitors

Európska únia - angličtina - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastic agents - breast cancermetastatic breast cancerogivri is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatmentsin combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitablein combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic diseasein combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive mbc, not previously treated with trastuzumab.early breast cancer                     ogivri is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc):following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable)following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxelin combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.in combination with neoadjuvant chemotherapy followed by adjuvant ogivri therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.ogivri should only be used in patients with metastatic or ebc whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay.metastatic gastric cancerogivri in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.ogivri should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. accurate and validated assay methods should be used.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: water for injections; sodium hydroxide; protamine sulfate; phenol; dibasic sodium phosphate heptahydrate; glycerol; metacresol; hydrochloric acid; zinc oxide - for the treatment of insulin dependent diabetic patients.