South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

pharma dynamics (pty) ltd - tablet - 75,0 mg - each tablet contains isoniazid 50,0 mgrifampicin 75,0 mg

Australia - English - Department of Health (Therapeutic Goods Administration)

isoniazid -

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - isoniazid, quantity: 100 mg - tablet, uncoated - excipient ingredients: propyl hydroxybenzoate; colloidal anhydrous silica; wheat starch; calcium stearate; sodium benzoate; dextrin; microcrystalline cellulose; sodium starch glycollate; gelatin; maize starch; lactose monohydrate - indications as at 21 oct 1999 : treatment of pulmonary and extrapulmonary tuberculosis in combination with other antitubercular agents.

Israel - English - Ministry of Health

taro pharmaceutical industries ltd - triamcinolone - tablets - triamcinolone 4 mg - triamcinolone - triamcinolone - rheumatology: - active phases of systemic vasculitis: panarteritis nodosa (in patients with concomitant positive hepatitis b serology, the duration of treatment should be restricted to two weeks), polymyalgia rheumatica (pmr), pmr with giant cell arteritis, arteritis temporalis with acute visual loss;- active phases of systemic rheumatic disease: systemic lupus erythematosus, mixed connective tissue disease;- severe progressive forms of active rheumatoid arthritis, e.g. rapidly destructive forms and/or with extra-articular manifestations;- other forms of inflammatory rheumatic arthritis, provided that the severity of symptoms requires it and non-steroidal anti-inflammatory drugs (nsaids) cannot be used:spondylarthritis (ankylosing spondylitis with involvement of peripheral joints, psoriatic arthritis, enteropathic arthropathy with high inflammatory activity);- reactive forms of arthritis;- arthritis in sarcoidosis;- severe systemic form of juvenile idiopathic arthritis (still’s disease) or with iridocyclitis refractory to topical treatment.pulmonary and respiratory tract disorders: - bronchial asthma:for the long-term treatment of severe chronic asthma (category 4) and for treatment of exacerbations in adults and children.- chronic obstructive pulmonary disease (copd):for short-term treatment (max. 14 days) of exacerbations;- upper respiratory tract disorders:for short-term treatment of severe forms of allergic rhinitis in adults after failure of all other treatment alternatives, including topical glucocorticoids.dermatology: - oral initial treatment of extensive, severe, acute skin conditions responsive to glucocorticoids, such as: allergic skin disease (e.g. acute urticaria, contact dermatitis, drug eruption), atopic eczema (acute exacerbations or extensive weeping eczema), pemphigus vulgaris.nephrology: - minimal change glomerulonephritis;- extracapillary proliferative glomerulonephritis (rapidly progressive glomerulonephritis), generally in combination with cytostatics, tapering and ending treatment in goodpasture’s syndrome; for all other forms, long-term continuation of treatment;- idiopathic retroperitoneal fibrosis.

Singapore - English - HSA (Health Sciences Authority)

dksh singapore pte. ltd. - midazolam - injection - 5 mg/5 ml - midazolam 1 mg/ml

Singapore - English - HSA (Health Sciences Authority)

dksh singapore pte. ltd. - midazolam - injection - 15 mg/3 ml - midazolam 5 mg/ml

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - bromocriptine mesilate, quantity: 5.735 mg (equivalent: bromocriptine, qty 5 mg) - capsule, hard - excipient ingredients: iron oxide red; gelatin; magnesium stearate; titanium dioxide; lactose monohydrate; shellac; indigo carmine; maleic acid; colloidal anhydrous silica; maize starch - prevention of onset of lactation in the puerperium for clearly defined medical reasons. therapy should be continued for 14 days to prevent rebound lactation. parlodel should not be used to suppress established lactation. treatment of hyperprolactinaemia where surgery and/or radiotherapy are not indicated or have already been used with incomplete resolution. precautions should be taken to ensure that the hyperprolactinaemia is not due to severe primary hypothyroidism. where the cause of hyperprolactinaemia is a prolactin-secreting microadenoma or macroadenoma, parlodel is indicated for conservative treatment; prior to surgery in order to reduce tumour size and to facilitate removal; after surgery if prolactin level is still elevated. adjunctive therapy in the management of acromegaly when: (1) the patient refuses surgery and/or radiotherapy; (2) surgery and/or radiotherapy has been unsuccessful or full effects are not expected for some months; (3) a manifestation of the acromegaly needs to be brought under con

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

healol pharmaceuticals sdn. bhd. - iron(iii) hydroxide polymaltose complex; folic acid; ascorbic acid -

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

macleods pharmaceuticals limited, india - pyrazinamide - tablets - 500

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

macleods pharmaceuticals limited, india - pyrazinamide - tablets - 400