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

pharma-q holdings (pty) ltd - injection - see ingredients - each 1 ml liquid contains epinephrine bitartrate 1,80 mg equivalent to epinephrine 1 mg

Malta - English - Medicines Authority

brillpharma (ireland) limited inniscarra, main street, rathcoole, co. dublin, ireland - telmisartan - tablet - telmisartan 20 mg - agents acting on the renin-angiotensin system

Malta - English - Medicines Authority

brillpharma (ireland) limited inniscarra, main street, rathcoole, co. dublin, ireland - telmisartan - tablet - telmisartan 40 mg - agents acting on the renin-angiotensin system

Malta - English - Medicines Authority

brillpharma (ireland) limited inniscarra, main street, rathcoole, co. dublin, ireland - telmisartan - tablet - telmisartan 80 mg - agents acting on the renin-angiotensin system

European Union - English - EMA (European Medicines Agency)

1 a pharma gmbh - rivastigmine - alzheimer disease; dementia; parkinson disease - psychoanaleptics, - symptomatic treatment of mild to moderately severe alzheimer's dementia.symptomatic treatment of mild to moderately severe dementia in patients with idiopathic parkinson's disease.

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

mayne pharma international pty ltd - erythromycin, quantity: 250 mg - capsule, enteric - excipient ingredients: povidone; monobasic potassium phosphate; lactose monohydrate; gelatin; carbon black; sunset yellow fcf; shellac; indigo carmine; purified water; cellacefate; erythrosine; diethyl phthalate - mayne pharma erythromycin is indicated in children and adults for the treatment of the following conditions: upper respiratory tract infections of mild to moderate degree caused by streptococcus pyogenes (group a beta haemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae). lower respiratory tract infections of mild to moderate severity caused by streptococcus pyogenes (group a beta hemolytic streptococci), streptococcus pneumoniae (diplococcus pneumoniae), acute and chronic bronchitis, pneumonia. sinusitis caused by streptococcus pneumoniae, streptococcus pyogenes. otitis media due to streptococcus pneumoniae, streptococcus pyogenes. respiratory tract infections due to mycoplasma pneumonia (eaton's agent). skin, and skin structure infections of mild to moderate severity caused by streptococcus pyogenes and staphylococcus aureus (resistant staphylococci may emerge during treatment). bordetella pertussis: erythromycin produces early elimination of the causative organism from the nasopharynx although the clinical course of the disease is not altered; therapeutic doses should be continued for at least 10 days. diphtheria: as an adjunct to antitoxin infections due to corynebacterium diphtheriae, to prevent establishment of carriers and to eradicate the organism in carriers. erythrasma: in the treatment of infections due to corynebacterium minutissimum. infections due to listera monocytogenes. non-gonococcal urethritis: chlamydia trachomatis and ureaplasma urealyticum have been shown to be sensitive to erythromycin and clinical studies have demonstrated its efficacy in urethritis due to these organisms. a minimum of 10 days therapy appears to be required. chlamydia trachomatis infection (excluding non-gonococcal urethritis): erythromycin has been shown to be effective in the treatment of trachoma or inclusion-body conjunctivitis and pneumonia in infants caused by chlamydia trachomatis. campylobacter fetus (subspecies) jejuni: infections due to this organism when antibiotic therapy is indicated. primary syphilis caused by treponema pallidum: erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. in the treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the followup after therapy. legionnaires' disease caused by legionella pneumophila: although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating legionnaires' disease. prevention of initial attacks of rheumatic fever: penicillin is considered by the american heart association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of group a beta - haemolytic streptococcal infections of the upper respiratory tract e.g. tonsillitis or pharyngitis). erythromycin is indicated for the treatment of penicillin allergic patients. a therapeutic dose should be administered for 10 days. prevention of recurrent attacks of rheumatic fever: penicillin or sulphonamides are considered by the american heart association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. in patients who are allergic to penicillin and sulphonamides, oral erythromycin is recommended by the american heart association in the long term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever). prevention of bacterial endocarditis: although no controlled clinical efficacy trials have been conducted, oral erythromycin has been suggested by the american heart association and the american dental association in a regimen for prophylaxis against bacterial endocarditis in patients sensitive to penicillin who have congenital heart disease, or rheumatic or other acquired valvular heart disease when they undergo dental or surgical procedures of the upper respiratory tract. erythromycin is not suitable prior to genitourinary or gastrointestinal tract surgery.

European Union - English - EMA (European Medicines Agency)

teva pharma b.v.  - clopidogrel (as hydrobromide) - peripheral vascular diseases; acute coronary syndrome; myocardial infarction; stroke - antithrombotic agents - prevention of atherothrombotic eventsclopidogrel is indicated in:adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease;adult patients suffering from acute coronary syndrome: non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa);st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy.prevention of atherothrombotic and thromboembolic events in atrial fibrillationin adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin-k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke.

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)

southern cross pharma pty ltd - amisulpride, quantity: 100 mg - tablet, uncoated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium starch glycollate type a; hypromellose - amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.