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. 

European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - pioglitazone hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes - pioglitazone is indicated in the treatment of type-2 diabetes mellitus as monotherapy: , in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance. , pioglitazone is also indicated for combination with insulin in type 2 diabetes mellitus adult patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance. after initiation of therapy with pioglitazone, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in hba1c). in patients who fail to show an adequate response, pioglitazone should be discontinued. in light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.,

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 of infections caused by the following gram-negative micro-organisms: vibrio species: cholera. brucella species: brucellosis (in conjunction with streptomycin). yersinia pestis: plague. francisella tularensis: tularemia. bartonella bacilliformis: bartonellosis. bacteroides species. when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: treponema pallidum: syphilis. treponema pertenue: yaws. neisseria gonorrhoea: gonorrhoea (see dosage and administration). mayne pharma doxycycline capsules is not the drug of choice in the treatment of any type of staphylococcal infection or infections caused by streptococcus pneumoniae, haemophilus influenzae, streptococcus pyogenes, streptococcus faecalis, or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxycycline should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory tract infections due to group a beta-haemolytic streptococci (including prophylaxis of rheumatic fever) penicillin is the usual drug of choice. doxycycline is active against both pre-erythroycitic and asexual bloodstages of plasmodium falciparum. the tetracyclines are only partially active against the pre-erythrocytic stages of plasmodium vivax and protection depends on drug suppression of the blood stages. doxycycline has no activity against the relapsing forms (hypnozoites) of plasmodium vivax. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine. in acute intestinal amoebiasis mayne pharma doxycycline capsules may be a useful adjunct to amoebicides. in severe acne mayne pharma doxycycline capsules may be a useful adjunctive therapy.

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 of infections caused by the following gram-negative micro-organisms: vibrio species: cholera. brucella species: brucellosis (in conjunction with streptomycin). yersinia pestis: plague. francisella tularensis: tularemia. bartonella bacilliformis: bartonellosis. bacteroides species. when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: treponema pallidum: syphilis. treponema pertenue: yaws. neisseria gonorrhoea: gonorrhoea (see dosage and administration). mayne pharma doxycycline capsules is not the drug of choice in the treatment of any type of staphylococcal infection or infections caused by streptococcus pneumoniae, haemophilus influenzae, streptococcus pyogenes, streptococcus faecalis, or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxycycline should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory tract infections due to group a beta-haemolytic streptococci (including prophylaxis of rheumatic fever) penicillin is the usual drug of choice. doxycycline is active against both pre-erythroycitic and asexual bloodstages of plasmodium falciparum. the tetracyclines are only partially active against the pre-erythrocytic stages of plasmodium vivax and protection depends on drug suppression of the blood stages. doxycycline has no activity against the relapsing forms (hypnozoites) of plasmodium vivax. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine. in acute intestinal amoebiasis manye pharma doxycycline capsules may be a useful adjunct to amoebicides. in severe acne mayne pharma doxycycline capsules may be a useful adjunctive therapy

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

Malta - English - Medicines Authority

+pharma arzneimittel gmbh hafnerstrasse 211 8054 graz , austria - film-coated tablet - vildagliptin 50 mg metformin hydrochloride 850 mg - drugs used in diabetes

Malta - English - Medicines Authority

+pharma arzneimittel gmbh hafnerstrasse 211 8054 graz , austria - film-coated tablet - metformin hydrochloride 1000 mg vildagliptin 50 mg - drugs used in diabetes

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

noumed pharmaceuticals pty ltd - pseudoephedrine hydrochloride, quantity: 30 mg; chlorphenamine maleate, quantity: 2 mg; paracetamol, quantity: 500.4 mg - tablet, uncoated - excipient ingredients: microcrystalline cellulose; magnesium stearate; crospovidone; pregelatinised maize starch; povidone; purified water; erythrosine aluminium lake; stearic acid - temporary relief of the symptoms of sinus headache, pain and nasal congestion (including fever) and hay fever.