Ireland - English - HPRA (Health Products Regulatory Authority)

abbvie limited - botulinum toxin type a - powder for solution for injection - other muscle relaxants, peripherally acting agents; botulinum toxin

Ireland - English - HPRA (Health Products Regulatory Authority)

abbvie limited - botulinum toxin type a - powder for solution for injection - other muscle relaxants, peripherally acting agents; botulinum toxin

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

evolus, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - jeuveau is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. jeuveau is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [see warnings and precautions (5.4) ]. jeuveau is contraindicated in the presence of infection at the proposed injection site(s). the limited available data on jeuveau use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. an embryofetal developmental study conducted with jeuveau in pregnant rats revealed no treatment-related effects to the developing fetus when jeuveau was administered intramuscularly during organogenesis at doses up to 12 times the maximum recommended human dose (mrhd) (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. animal data in an embryofetal developmental study, intramuscular doses up to 4 unit/kg jeuveau were administered to pregnant rats once daily during organogenesis (gestation days 6 to 16). no maternal or embryofetal toxicities were observed at doses up to 4 unit/kg (12 times the mrhd of 20 units, based on unit/kg comparison). there is no information regarding the presence of prabotulinumtoxina-xvfs in human or animal milk, its effects on the breastfed infant, or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for jeuveau and any potential adverse effects on the breastfed infant from jeuveau or from the underlying maternal condition safety and effectiveness in pediatric patients have not been established. the two clinical trials of jeuveau included 68 subjects age 65 and greater. although no differences in safety or efficacy were observed between older and younger subjects, clinical studies of jeuveau did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

revance therapeutics, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - daxxify is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. daxxify is indicated for the treatment of cervical dystonia in adult patients. daxxify is contraindicated in: - patients with known hypersensitivity to any botulinum toxin preparation, daxxify, or any of the components in the daxxify formulation [see warnings and precautions (5.4)]. - the presence of infection at the proposed injection sites. risk summary there are no available data on daxxify use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, intramuscular administration of daxxify during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at maternally toxic doses approximately equivalent to 40 times the maximum recommended human dose (mrhd) (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data embryofetal development studies were conducted in rats and rabbits with daxxify. for comparison of animal to human doses based on a body weight comparison, the mrhd is set at 40 units/subject (0.67 units/kg for an average 60 kg subject). intramuscular administration of daxxify (3, 10, or 30 units/kg) to pregnant rats four times during the period of organogenesis (on gestation days 7, 10, 13, and 16) caused decreased fetal body weight and decreased fetal skeletal ossification at the highest dose, which was associated with maternal toxicity. no embryofetal developmental toxicity was noted at doses up to 10 units/kg, which is 15 times the mrhd. intramuscular administration of daxxify (0.02, 0.1, 0.48, or 2.4 units/kg/day) to pregnant rabbits during the period of organogenesis (total of 13 doses) resulted in maternal lethality at 2.4 units/kg/day and significant decreased maternal body weight at 0.48 units/kg/day. no embryofetal developmental toxicity was noted at doses up to 0.48 units/kg/day, which is approximately equivalent to the mrhd. risk summary there are no data on the presence of daxxify in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for daxxify and any potential adverse effects on the breastfed infant from daxxify or from the underlying maternal condition. safety and effectiveness of daxxify in patients less than 18 years of age have not been established. glabellar lines among the 406 subjects treated with daxxify in the placebo-controlled clinical trials, 36 subjects were 65 years or older. there was no increase in the incidence of treatment-related adverse events in patients over 65 years treated with daxxify. clinical studies of daxxify did not include sufficient numbers of subjects aged 65 and older to determine whether they responded differently from younger subjects [see clinical studies (14)]. cervical dystonia among the 255 patients treated with daxxify in the placebo-controlled clinical trial, 83 patients were 65 years or older. there was no increase in the incidence of treatment-related adverse events in patients over 65 years treated with daxxify. clinical studies of daxxify did not include sufficient numbers of patients aged 65 and older to determine whether they responded differently from younger patients [see clinical studies (14)].

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

zoetis australia pty ltd - clostridium botulinum type c toxoid; clostridium botulinum type d toxoid; thiomersal - parenteral liquid/solution/suspension - clostridium botulinum type c toxoid vaccine-toxoid active 0.0 p; clostridium botulinum type d toxoid vaccine-toxoid active 0.0 p; thiomersal mercury other 0.1 mg/ml - immunotherapy - cattle | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | heifer | steer - botulism

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

special order - botulinum antitoxin type a; botulinum antitoxin type b; botulinum antitoxin type c; botulinum antitoxin type d; botulinum antitoxin type e; botulinum antitoxin type f; botulinum antitoxin type g - powder for solution for injection - 897unit ; 3525unit ; 1545unit ; 495unit ; 1635unit ; 1560unit ; 481unit

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

virbac (australia) pty ltd - clostridium botulinum type c toxoid; clostridium botulinum type d toxoid; thiomersal - misc. vaccines or anti sera - clostridium botulinum type c toxoid vaccine-toxoid active 5.0 iu/ml; clostridium botulinum type d toxoid vaccine-toxoid active 1.0 iu/ml; thiomersal mercury other 0.13 g/l - immunotherapy - cattle | sheep | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | ewe | heifer | h - botulism

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

virbac (australia) pty ltd - clostridium botulinum type c toxoid; clostridium botulinum type d toxoid; thiomersal - parenteral liquid/solution/suspension - clostridium botulinum type c toxoid vaccine-toxoid active 0.0 p; clostridium botulinum type d toxoid vaccine-toxoid active 0.0 p; thiomersal mercury other 0.13 g/l - immunotherapy - bull | cattle | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | heifer | male cat - botulism

Israel - English - Ministry of Health

medison pharma ltd - botulinum toxin type a - powder for solution for injection - botulinum toxin type a 300 u/vial - botulinum toxin - dysport is indicated for symptomatic treatment of focal spasticity of:- upper limbs in adults due to stroke or traumatic brain injury- lower limbs in adults affecting the ankle joint due to stroke or traumatic brain injury (tbi) - dynamic equinus foot deformity in ambulant paediatric cerebral palsy patients, two years of age or older.- upper limbs in pediatric cerebral palsy patients, two years of age or older.dysport is indicated in adults for symptomatic treatment of:- spasmodic torticollis- blepharospasm- hemifacial spasm.dysport is indicated for symptomatic treatment of persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment.dysport is indicated for the temporary improvement in the appearance of moderate to severe:- glabellar lines (vertical lines between the eyebrows) seen at frown,and/or - lateral canthal lines (crow’s feet lines) seen at maximum smile in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.

Israel - English - Ministry of Health

medison pharma ltd - botulinum toxin type a - powder for solution for injection - botulinum toxin type a 500 u/vial - botulinum toxin - dysport is indicated for symptomatic treatment of focal spasticity of:- upper limbs in adults due to stroke or traumatic brain injury- lower limbs in adults affecting the ankle joint due to stroke or traumatic brain injury (tbi) - dynamic equinus foot deformity in ambulant paediatric cerebral palsy patients, two years of age or older.- upper limbs in pediatric cerebral palsy patients, two years of age or older.dysport is indicated in adults for symptomatic treatment of:- spasmodic torticollis- blepharospasm- hemifacial spasm.dysport is indicated for symptomatic treatment of persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment.dysport is indicated for the temporary improvement in the appearance of moderate to severe:- glabellar lines (vertical lines between the eyebrows) seen at frown,and/or - lateral canthal lines (crow’s feet lines) seen at maximum smile in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.