Irland - engelska - HPRA (Health Products Regulatory Authority)

wockhardt uk limited - amitriptyline hydrochloride - oral solution - 50 mg/5ml - non-selective monoamine reuptake inhibitors; amitriptyline

Australien - engelska - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - tigecycline, quantity: 50 mg - injection, powder for - excipient ingredients: arginine; hydrochloric acid; sodium hydroxide - tigecycline juno is indicated for the treatment of the following infections in adults:,? complicated skin and skin structure infections, including those with methicillin resistant staphylococcus aureus (mrsa), where there is suspected or proven resistance to, intolerance of, or there are co- morbidities preventing the use of, other available agents.,? complicated intra-abdominal infections, where there is suspected or proven resistance to, intolerance of, or there are co-morbidities preventing the use of, other available agents.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - fulvestrant, quantity: 50 mg/ml - injection, solution - excipient ingredients: ethanol; benzyl alcohol; benzyl benzoate; castor oil - faslodex is indicated for the treatment of postmenopausal women with:,? hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, locally advanced or metastatic breast cancer who have not been previously treated with endocrine therapy.,? hr positive, locally advanced or metastatic breast cancer who have progressive disease following prior endocrine (anti-oestrogen or aromatase inhibitor) therapy.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amdipharm mercury australia pty ltd - erythromycin ethyl succinate -

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - risperidone - powder and solvent for suspension for injection - 50mg

Australien - engelska - Department of Health (Therapeutic Goods Administration)

amdipharm mercury australia pty ltd - erythromycin ethyl succinate -

Armenien - engelska - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

hankook korus pharm co. - fluconazole - capsules hard - 150mg

Malta - engelska - Medicines Authority

doc generici srl via turati, 40-20121, milano, italy - oral drops, solution - paroxetine 10 mg/ml - psychoanaleptics

Australien - engelska - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents. daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age),complicated skin and skin structure infections,daptomycin wkt is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wkt is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin wkt is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wkt is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents. daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age) complicated skin and skin structure infections,daptomycin wockhardt is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wockhardt is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age) daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin wockhardt is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wockhardt is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.