European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - pramipexole dihydrochloride monohydrate - restless legs syndrome; parkinson disease - anti-parkinson drugs - mirapexin is indicated for treatment of the signs and symptoms of idiopathic parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).mirapexin is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).

United States - English - NLM (National Library of Medicine)

boehringer ingelheim pharmaceuticals, inc. - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.375 mg - mirapex er® tablets are indicated for the treatment of parkinson's disease. none. risk summary there are no adequate data on the developmental risk associated with the use of mirapex er in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data ]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. this incre

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

medis pharma pty ltd - capecitabine -

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

medis pharma pty ltd - capecitabine -

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

dechra veterinary products (australia) pty. ltd. - levothyroxine sodium (97%-102%) - oral solution/suspension - levothyroxine sodium (97%-102%) active 1.0 mg/ml - endocrine system

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

dechra veterinary products (australia) pty. ltd. - neomycin sulfate; polymyxin b sulfate; lignocaine hydrochloride; nitrofurazone; pyrethrins - misc. aural, ophthalmic, oro/naso pharyngeal - neomycin sulfate antibiotic active 5.0 mg/ml; polymyxin b sulfate antibiotic active 10000.0 units/ml; lignocaine hydrochloride caine active 2.5 mg/ml; nitrofurazone nitrofuran active 2.6 mg/ml; pyrethrins pyrethroid-pyrethrin active 0.5 mg/ml - ear,nose,throat preps. - cat | dog | horse | bitch | castrate | cat - queen | cat - tom | colt | donkey | endurance horse | filly | foal | gelding | high - ear mange mite | otitis externa | acute canine otitis | associated with yeast &/or bac | chronic canine otitis | ear mites | malassezia pachydermatis | otitis (canine)

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

dechra veterinary products (australia) pty. ltd. - stilboestrol - oral tablet - stilboestrol steroid-estrogen active 1.0 mg/tb - endocrine system - dog | bitch | castrate | puppy - incontinence - hormone responsive | prostatic carcinomata | suppression of laction in bitches

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

dechra veterinary products (australia) pty. ltd. - amoxycillin as amoxycillin trihydrate - oral tablet - amoxycillin as amoxycillin trihydrate antibiotic active 200.0 mg/tb - antibiotic & related - cat | dog | bitch | castrate | cat - queen | cat - tom | kitten | puppy - bacterial infection | amoxycillin sensitive bacteria | associated with viral disease | gram negative organisms | gram positive organisms | post parturient bacterial infe | primary bacterial infection | sulfadiazine sensitive bacteri | trimethoprim sensitive bacteri | tylosin sensitive bacteria

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

dechra veterinary products (australia) pty. ltd. - amoxycillin as amoxycillin trihydrate - oral tablet - amoxycillin as amoxycillin trihydrate antibiotic active 400.0 mg/tb - antibiotic & related - cat | dog | bitch | castrate | cat - queen | cat - tom | kitten | puppy - bacterial infection | amoxycillin sensitive bacteria | associated with viral disease | gram negative organisms | gram positive organisms | post parturient bacterial infe | primary bacterial infection | sulfadiazine sensitive bacteri | trimethoprim sensitive bacteri | tylosin sensitive bacteria

European Union - English - EMA (European Medicines Agency)

swedish orphan biovitrum ab - collagenase clostridium histolyticum - dupuytren contracture - other drugs for disorders of the musculo-skeletal system - , the treatment of dupuytren’s contracture in adult patients with a palpable cord., the treatment of adult men with peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.