Malta - English - Medicines Authority

bayer public limited company 400 south oak way, reading berkshire rg2 6ad, united kingdom - drospirenone, ethinylestradiol - film-coated tablet - drospirenone 3 mg ethinylestradiol 0.02 mg - sex hormones and modulators of the genital system

Ireland - English - HPRA (Health Products Regulatory Authority)

bayer limited - drospirenone micronized ethinylestradiol (as betadex clathrate micronized) - film coated tablet - 0.02/3 milligram

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - captopril 5.5 mg/ml (includes 10% excess);  ;  ; captopril 5.5 mg/ml - oral solution - 5 mg/ml - active: captopril 5.5 mg/ml (includes 10% excess)     excipient: citric acid disodium edetate dihydrate hydrochloric acid purified water sodium benzoate sodium citrate dihydrate sodium hydroxide active: captopril 5.5 mg/ml excipient: citric acid disodium edetate dihydrate hydrochloric acid purified water sodium benzoate sodium citrate dihydrate sodium hydroxide - capoten (captopril) is indicated for the treatment of hypertension. in using capoten, consideration should be given to the risk of neutropenia/agranulocytosis. capoten is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of captopril and thiazides are approximately additive.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - salbutamol sulfate 120.5ug equivalent to 100 µg dose (10% excess may be added to compensate for manufacturing loss);   - aerosol inhaler, metered dose - 100 mcg/dose - active: salbutamol sulfate 120.5ug equivalent to 100 µg dose (10% excess may be added to compensate for manufacturing loss)   excipient: norflurane - salbutamol is a selective ?2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. it provides short acting (four hours) bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. for patients with asthma salbutamol may be used to relieve symptoms when they occur and to prevent them prior to a known trigger. bronchodilators should not be the only or main treatment in patients with persistent asthma. in patients with persistent asthma unresponsive to salbutamol, treatment with inhaled corticosteroids is recommended to achieve and maintain control. failure to respond promptly or fully to such rescue medication signals a need for urgent medical advice and treatment.

New Zealand - English - Medsafe (Medicines Safety Authority)

upjohn new zealand ulc - alprazolam 0.25mg (exclusive of 1.5% excess.);  ;   - tablet - 0.25 mg - active: alprazolam 0.25mg (exclusive of 1.5% excess.)     excipient: colloidal silicon dioxide [docusate sodium (85% ) with sodium benzoate [15%] lactose monohydrate magnesium stearate maize starch microcrystalline cellulose - 1. anxiety states (anxiety neuroses). symptoms which occur in such patients include anxiety, tension, fear, insomnia, apprehension, restlessness, concentration difficulties, irritability and/or autonomic hyperactivity resulting in a variety of somatic complaints. 2. mixed anxiety-depression. symptoms of both anxiety and depression occur concurrently in such patients. 3. neurotic or reactive depression. such patients primarily exhibit a depressed mood or a pervasive loss of interest or pleasure. other characteristics include anxiety, appetite disturbances, changes in weight, cognitive disturbances, decreased energy, feeling of worthlessness or guilt, insomnia, somatic complaints, or thoughts of death or suicide. 4. anxiety states, mixed anxiety-depression, or neurotic depression associated with other diseases such as the chronic phase of alcohol withdrawal and functional or organic disease, particularly certain gastrointestinal, cardiovascular, or dermatological disorders.

New Zealand - English - Medsafe (Medicines Safety Authority)

upjohn new zealand ulc - alprazolam 0.5mg (exclusive of 1.5% excess.);  ;   - tablet - 0.5 mg - active: alprazolam 0.5mg (exclusive of 1.5% excess.)     excipient: colloidal silicon dioxide docusate sodium erythrosine lactose monohydrate magnesium stearate maize starch microcrystalline cellulose sodium benzoate - 1. anxiety states (anxiety neuroses). symptoms which occur in such patients include anxiety, tension, fear, insomnia, apprehension, restlessness, concentration difficulties, irritability and/or autonomic hyperactivity resulting in a variety of somatic complaints. 2. mixed anxiety-depression. symptoms of both anxiety and depression occur concurrently in such patients. 3. neurotic or reactive depression. such patients primarily exhibit a depressed mood or a pervasive loss of interest or pleasure. other characteristics include anxiety, appetite disturbances, changes in weight, cognitive disturbances, decreased energy, feeling of worthlessness or guilt, insomnia, somatic complaints, or thoughts of death or suicide. 4. anxiety states, mixed anxiety-depression, or neurotic depression associated with other diseases such as the chronic phase of alcohol withdrawal and functional or organic disease, particularly certain gastrointestinal, cardiovascular, or dermatological disorders.

New Zealand - English - Medsafe (Medicines Safety Authority)

upjohn new zealand ulc - alprazolam 1mg (exclusive of 1.5% excess.);  ;   - tablet - 1 mg - active: alprazolam 1mg (exclusive of 1.5% excess.)     excipient: colloidal silicon dioxide erythrosine indigo carmine docusate sodium (85%) with sodium benzoate (15%) lactose monohydrate magnesium stearate maize starch microcrystalline cellulose - 1. anxiety states (anxiety neuroses). symptoms which occur in such patients include anxiety, tension, fear, insomnia, apprehension, restlessness, concentration difficulties, irritability and/or autonomic hyperactivity resulting in a variety of somatic complaints. 2. mixed anxiety-depression. symptoms of both anxiety and depression occur concurrently in such patients. 3. neurotic or reactive depression. such patients primarily exhibit a depressed mood or a pervasive loss of interest or pleasure. other characteristics include anxiety, appetite disturbances, changes in weight, cognitive disturbances, decreased energy, feeling of worthlessness or guilt, insomnia, somatic complaints, or thoughts of death or suicide. 4. anxiety states, mixed anxiety-depression, or neurotic depression associated with other diseases such as the chronic phase of alcohol withdrawal and functional or organic disease, particularly certain gastrointestinal, cardiovascular, or dermatological disorders.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - interferon beta-1b 0.25mg (20% excess in quantity filled) - injection with diluent - 8 miu - active: interferon beta-1b 0.25mg (20% excess in quantity filled) excipient: albumin hydrochloric acid mannitol sodium hydroxide hydrochloric acid sodium chloride water for injection - betaferon is indicated for: · the treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent magnetic resonance imaging (mri) lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded, · the treatment of ambulatory patients, with relapsing-remitting multiple sclerosis characterised by at least two attacks of neurological dysfunction over a two year period followed by complete or incomplete recovery. · the reduction of frequency and severity of clinical relapses and for slowing the progression of disease in patients with secondary progressive multiple sclerosis

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - clobetasol propionate 0.0525%{relative} (5% excess included);   - scalp lotion - 0.05% w/w - active: clobetasol propionate 0.0525%{relative} (5% excess included)   excipient: carbomer isopropyl alcohol purified water sodium hydroxide

New Zealand - English - Medsafe (Medicines Safety Authority)

bristol-myers squibb (nz) limited - fluphenazine decanoate 25 mg/ml (26.88mg added to provide 25mg/ml plus a 7.5% excess.) - injection (depot) - 25 mg/ml - active: fluphenazine decanoate 25 mg/ml (26.88mg added to provide 25mg/ml plus a 7.5% excess.) excipient: benzyl alcohol nitrogen sesame oil - fluphenazine decanoate is indicated in the long-term management of psychotic disorders including schizophrenia, mania and organic brain syndrome. it is of particular value in the treatment of chronic schizophrenia and for patients who are unreliable at taking oral medication. the drug often alleviates such target symptoms as hallucinations, delusions, confusion and withdrawal. it is not only useful in the hospital milieu but is unparalleled, because of its long duration of action in the long-term maintenance therapy of chronically psychotic patients who are amenable to out-patient therapy. fluphenazine decanoate has not been shown to be effective in the management of behavioural complications in patients with mental retardation.