Malta - English - Medicines Authority

pharmconsul s.r.o. krcmárovská 223/33, miskovice, prague 9, 196 00, , czech republic - orodispersible tablet - olanzapine 10 mg - psycholeptics

Malta - English - Medicines Authority

pharmconsul s.r.o. krcmárovská 223/33, miskovice, prague 9, 196 00, , czech republic - orodispersible tablet - olanzapine 15 mg - psycholeptics

Malta - English - Medicines Authority

pharmconsul s.r.o. krcmárovská 223/33, miskovice, prague 9, 196 00, , czech republic - orodispersible tablet - olanzapine 20 mg - psycholeptics

Ireland - English - HPRA (Health Products Regulatory Authority)

pharma regulatory solutions ltd - voriconazole - pdr for soln for infusion - 200 milligram - triazole derivatives - antimycotics for systemic use, triazole derivatives - voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis. treatment of candidaemia in non-neutropenic patients. treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). treatment of serious fungal infections caused by scedosporium spp. and fusarium spp. voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - budesonide, formoterol - asthma - drugs for obstructive airway diseases, - budesonide/formoterol teva pharma b.v. is indicated in adults 18 years of age and older only.asthmabudesonide/formoterol teva pharma b.v. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists. 

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

mayne pharma international pty ltd - doxycycline hyclate, quantity: 116.3 mg (equivalent: doxycycline, qty 100 mg) - capsule, modified release - excipient ingredients: microcrystalline cellulose; purified water; hypromellose phthalate; povidone; diethyl phthalate; magnesium stearate; wheat starch; hypromellose; lactose monohydrate; hyprolose; gelatin; ethanol; shellac; pharmaceutical glaze; carbon black - doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. doxycycline is active against a wide range of gram-positive and gram-negative organisms. note: the 50 mg capsule is not a paediatric formulation. mayne pharma doxycycline capsules are indicated in the treatment of infections caused by the following micro-organisms: mycoplasma pneumoniae: primary atypical pneumonia. rickettsiae: queensland tick typhus, typhus fever and q fever. agents of psittacosis. calymmatobacterium (donovania) granulomitis: granuloma inguinale. agents of lymphogranuloma venereum. borreliae: relapsing fever. chlamydia trachomatis. mayne pharma doxycycline capsules are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline capsules alone, or in combination with topical agents. mayne pharma doxycycline is indicated in the treatment

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

mayne pharma international pty ltd - doxycycline hyclate, quantity: 58.15 mg (equivalent: doxycycline, qty 50 mg) - capsule, modified release - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; hypromellose phthalate; hypromellose; hyprolose; povidone; wheat starch; diethyl phthalate; purified water; gelatin; ethanol; shellac; pharmaceutical glaze; carbon black - doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. doxycycline is active against a wide range of gram-positive and gram-negative organisms. note: the 50 mg capsule is not a paediatric formulation. mayne pharma doxycycline capsules are indicated in the treatment of infections caused by the following micro-organisms: mycoplasma pneumoniae: primary atypical pneumonia. rickettsiae: queensland tick typhus, typhus fever and q fever. agents of psittacosis. calymmatobacterium (donovania) granulomitis: granuloma inguinale. agents of lymphogranuloma venereum. borreliae: relapsing fever. chlamydia trachomatis. mayne pharma doxycycline capsules are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline capsules alone, or in combination with topical agents. mayne pharma doxycycline is indicated in the treatment

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

noumed pharmaceuticals pty ltd - pseudoephedrine hydrochloride, quantity: 60 mg - tablet, uncoated - excipient ingredients: calcium hydrogen phosphate dihydrate; magnesium stearate; microcrystalline cellulose - fast temporary relief from a runny nose and reduce the swollen membranes of the nose and sinuses and helping breathe freely.

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

noumed pharmaceuticals pty ltd - pseudoephedrine hydrochloride, quantity: 30 mg; paracetamol, quantity: 500.4 mg - tablet, uncoated - excipient ingredients: crospovidone; pregelatinised maize starch; povidone; purified water; microcrystalline cellulose; magnesium stearate; stearic acid - temporary relief of the following cold and flu symptoms: nasal congestion, sinus pain, runny nose, headache and body aches & pains. reduces fever

Israel - English - Ministry of Health

mbi pharma ltd., israel - dexamethasone phosphate ( as sodium phosphate ) - solution for injection / infusion - dexamethasone phosphate ( as sodium phosphate ) 4 mg/ml - dexamethasone - dexamethasone kern pharma is indicated in the treatment of:• endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia.• allergy: severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs.• ophtalmic: serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers.• inflammatory bowel dis.: systemic treatment in exacerbations of ulcerative colitis and regional enteritis.• dermatological diseases (pemphigus, stevens johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • respiratory diseases (symptomatic sarcoidosis, berylliosis, loeffler's syndrome)• haematological: acquired )autoimmune( haemolytic anaemia, idiopathic thrombocytopenic purpura in adult, pure red cell aplasia• nephrotic syndrome of the idioplathic type or that due to lupus erythematosus• cerebral edema caused by brain tumor, neurosurgery, brain abscess, bacterial meningitis• collagen diseases: active rheumatoid arthritis with severe progressive course, fast destructive remitting forms and / or extra-articular manifestations, juvenile idiopathic arthritis with severe systemic-onset form (still's disease) or locally with no control, rheumatic fever with carditis, dermatomyositis, polymyositis, sle, temporal arteritis.• infectious diseases: bacterial meningitis – adjunct to antibiotics in suspected pneumococcal meningitis and tb meningitis. severe infectious diseases with toxic states (eg tuberculosis, typhoid, brucellosis;. only with simultaneous anti-infective therapy)• fetal lung maturation• chemotherapy – associated nausea and vomiting• multiple myeloma – part of chemotherapy protocols (eg vad)• prevention and treatment of acute mountain sickness/hace