以色列 - 英文 - Ministry of Health

abbvie biopharmaceuticals ltd, israel - botulinum toxin type a - powder for solution for injection - botulinum toxin type a 200 u/vial - botulinum toxin - botulinum toxin - neurologic disorders:• •focal spasticity associated with dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients two years of age or older. • • focal spasticity of the wrist and hand in adult • focal spasticity of the lower limb, including ankle and foot in adult. • •blepharospasm or vii nerve disorders in patients over 12 years, hemifacial spasm and associated focal dystonias as well as the correction of strabismus in patients 12 years of age and above. • •reduction of the signs and symptoms of cervical dystonia (spasmodic torticollis) in adults. • •symptom relief in adults fulfilling criteria for chronic migraine (headaches on ≥15 days per month of which at least 8 days with migraine) in patients who have responded inadequately or are intolerant of prophylactic migraine medications. bladder disorders: •management of overactive bladder with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medication. •urinary incontinence in adults with neurogenic detrusor overactivity resulting from neurogenic bladder due to stable sub-cervical spinal cord injury, or multiple sclerosis. skin and skin appendage disorder: •management of primary axillary hyperhidrosis in patients who failed other medical symptomatic treatment. •for the temporary improvement in the appearance of: - moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) and/or, - moderate to severe lateral canthal lines (crow’s feet lines) seen at maximum smile and/or, - moderate to severe forehead lines seen at maximum eyebrow elevation when the severity of the facial lines has an important psychological impact in adult patients.

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

merz pharmaceuticals gmbh - clostridium botulinum neuro-toxin type a (150 kd), free from complexing proteins - powder for solution for injection - 50 - other muscle relaxants, peripherally acting agents; botulinum toxin

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

merz pharmaceuticals gmbh - clostridium botulinum neuro-toxin type a (150 kd), free from complexing proteins - powder for solution for injection - 100 - other muscle relaxants, peripherally acting agents; botulinum toxin

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

merz pharmaceuticals gmbh - clostridium botulinum neuro-toxin type a (150 kd), free from complexing proteins - powder for solution for injection - 200 - other muscle relaxants, peripherally acting agents; botulinum toxin

马来西亚 - 英文 - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

abbvie sdn bhd - clostridium botulinum toxin type a -

美国 - 英文 - NLM (National Library of Medicine)

merz north america, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 50 [usp'u] - xeomin is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. upper limb spasticity in adult patients xeomin is indicated for the treatment of upper limb spasticity in adult patients. upper limb spasticity in pediatric patients, excluding spasticity caused by cerebral palsy xeomin is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. xeomin is indicated for the treatment of cervical dystonia in adult patients. xeomin is indicated for the treatment of blepharospasm in adult patients. xeomin 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. xeomin is contraindicated in patients with: - known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see warnings and precautions (5.3) and description (11)] . - infection at t

美国 - 英文 - NLM (National Library of Medicine)

merz pharmaceuticals, llc - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 50 [usp'u] - xeomin is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older. upper limb spasticity in adult patients xeomin is indicated for the treatment of upper limb spasticity in adult patients. upper limb spasticity in pediatric patients, excluding spasticity caused by cerebral palsy xeomin is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. xeomin is indicated for the treatment of cervical dystonia in adult patients. xeomin is indicated for the treatment of blepharospasm in adult patients. xeomin 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. xeomin is contraindicated in patients with: - known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see warnings and precautions (5.3) and description (11)] . - infection at t

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

merz pharmaceuticals gmbh - clostridium botulinum neurotoxin type a (150kd), free of complexing proteins - powder for solution for injection - 100 unit(s) - botulinum toxin

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

merz pharmaceuticals gmbh - clostridium botulinum neurotoxin type a (150kd), free of complexing proteins - powder for solution for injection - 50 unit(s) - botulinum toxin

美国 - 英文 - NLM (National Library of Medicine)

allergan, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 50 [usp'u] - botox cosmetic (onabotulinumtoxina) is indicated in adult patients for the temporary improvement in the appearance of: - moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity - moderate to severe lateral canthal lines  associated with orbicularis oculi activity - moderate to severe forehead lines associated with frontalis muscle activity botox cosmetic 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 )] . botox cosmetic is contraindicated in the presence of infection at the proposed injection site(s). risk summary there are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of botox cosmetic in pregnant women.   in animal studies, administrations of botox cosmetic during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [see data]. 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. the background risk of major birth defects and miscarriage for the indicated populations is unknown. data animal data when botox cosmetic (4, 8, or 16 units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were observed at the two highest doses. the no-effect dose for developmental toxicity in these studies (4 units/kg) is approximately 4 times the average high human dose for glabellar lines, lateral canthal lines, and forehead lines of 64 units on a body weight basis (units/kg). when botox cosmetic was administered intramuscularly to pregnant rats (0.125, 0.25, 0.5, 1, 4, or 8 units/kg) or rabbits (0.063, 0.125, 0.25, or 0.5 units/kg) daily during the period of organogenesis (total of 12 doses in rats, 13 doses in rabbits), reduced fetal body weights and decreased fetal skeletal ossification were observed at the two highest doses in rats and at the highest dose in rabbits. these doses were also associated with significant maternal toxicity, including abortions, early deliveries, and maternal death. the developmental no-effect doses in these studies of 1 unit/kg in rats is approximately equal the average high human dose of 64 units based on units/kg, and the developmental no-effect dose of 0.25 units/kg in rabbits is less than the average high human dose based on units/kg. when pregnant rats received single intramuscular injections (1, 4, or 16 units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal development were observed. the developmental no-effect level for a single maternal dose in rats (16 units/kg) is approximately 16 times the average high human dose of 64 units based on units/kg. risk summary there are no data on the presence of botox cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for botox cosmetic and any potential adverse effects on the breastfed infant from botox cosmetic or from the underlying maternal conditions. safety and effectiveness in patients below the age of 18 years have not been established. glabellar lines in the two initial glabellar lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older [see clinical studies ( 14 )] . lateral canthal lines in the two lateral canthal lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older. forehead lines in the two forehead lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older.