European Union - English - EMA (European Medicines Agency)

aventis pharma s.a. - telithromycin - community-acquired infections; pharyngitis; bronchitis, chronic; pneumonia; tonsillitis; sinusitis - antibacterials for systemic use, - when prescribing levviax consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).levviax is indicated for the treatment of the following infections:in patients of 18 years and older:-community-acquired pneumonia, mild or moderate (see section 4.4).- when treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):- acute exacerbation of chronic bronchitis,- acute sinusitisin patients of 12 years and older:- tonsillitis/pharyngitis caused by streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant s. pyogenes, when mediated by ermtr or mefa (see sections 4.4 and 5.1).

European Union - English - EMA (European Medicines Agency)

aventis pharma s.a. - telithromycin - sinusitis; tonsillitis; bronchitis, chronic; pharyngitis; community-acquired infections; pneumonia, bacterial - antibacterials for systemic use, - when prescribing ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance.ketek is indicated for the treatment of the following infections:in patients of 18 years and oldercommunity-acquired pneumonia, mild or moderate.when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin:acute exacerbation of chronic bronchitis;acute sinusitis;in patients of 12 years and oldertonsillitis / pharyngitis caused by streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant s. pyogenes, when mediated by ermtr or mefa.

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

sanofi-aventis australia pty ltd - risedronate sodium; calcium carbonate; colecalciferol; cholecalciferol -

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - propamidine isetionate 0.1%{relative} - eye drops, solution - 0.1 % - active: propamidine isetionate 0.1%{relative} excipient: ammonium chloride benzalkonium chloride sodium chloride sodium hydroxide water for injection

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - fexofenadine hydrochloride 6 mg/ml; fexofenadine hydrochloride 6 mg/ml - oral suspension - 6 mg/ml - active: fexofenadine hydrochloride 6 mg/ml excipient: butyl hydroxybenzoate dibasic sodium phosphate heptahydrate disodium edetate monobasic sodium phosphate monohydrate poloxamer propyl hydroxybenzoate propylene glycol purified water raspberry flavour f-9950 pfc sucrose titanium dioxide xanthan gum xylitol active: fexofenadine hydrochloride 6 mg/ml excipient: dibasic sodium phosphate heptahydrate disodium edetate monobasic sodium phosphate monohydrate poloxamer potassium sorbate propylene glycol purified water raspberry flavour f-9950 pfc sucrose titanium dioxide xanthan gum xylitol - relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age.

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

sanofi-aventis (malaysia) sdn. bhd. - triamcinolone acetonide -

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

theramex australia pty ltd - calcium carbonate -

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

sanofi-aventis australia pty ltd - risedronate sodium; calcium carbonate; colecalciferol; cholecalciferol -

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - sodium cromoglicate 5mg equivalent to 3.5211% w/w;  ;   - aerosol inhaler, metered dose - 5 mg/dose - active: sodium cromoglicate 5mg equivalent to 3.5211% w/w     excipient: apaflurane macrogol 600 povidone - intal forte 5 mg cfc-free is indicated for the preventive treatment of bronchial asthma (which may be due to allergy, exercise, cold air or chemical irritants) in adults and children.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - nedocromil sodium 1.4085%{relative} (2 mg/dose);   - aerosol inhaler, metered dose - 2 mg/dose - active: nedocromil sodium 1.4085%{relative} (2 mg/dose)   excipient: apaflurane macrogol 600 menthol povidone - tilade cfc-free is indicated in the treatment of bronchial asthma (whether extrinsic or intrinsic in nature, and including asthmatic bronchitis, late onset asthma, exercise induced asthma, and bronchospasm provoked by a variety of stimuli such as cold air, inhaled allergens, atmospheric pollutants and other irritants). tilade cfc-free is intended for regular prophylactic treatment and not for symptomatic relief. in the management of asthma, tilade cfc-free improves pulmonary function, reduces the frequency and severity of attacks and reduces bronchospasm, cough and bronchial hyper-responsiveness. in patients already receiving treatment for their asthma, tilade cfc-free can be given in addition to all existing therapies and will in many cases provide added therapeutic benefit. having established this benefit of tilade cfc-free, it may be possible to gradually reduce or eliminate concomitant therapy.