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

merz australia pty ltd - incobotulinumtoxina, quantity: 100 u - injection, powder for - excipient ingredients: albumin; sucrose - xeomin is indicated in adults for the treatment of:,? cervical dystonia (spasmodic torticollis),? blepharospasm,? spasticity of the upper limb,? chronic sialorrhea due to neurological disorders,? upper facial lines,- glabellar frown lines,- lateral periorbital lines (crow?s feet),- horizontal forehead lines,xeomin is indicated in children and adolescents aged 2 years to 17 years for the symptomatic treatment of:,? chronic sialorrhea due to neurological/neurodevelopmental disorders,? spasticity of the lower and/or upper limbs

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

merz australia pty ltd - incobotulinumtoxina, quantity: 50 u - injection, powder for - excipient ingredients: albumin; sucrose - xeomin is indicated in adults for the treatment of:,? cervical dystonia (spasmodic torticollis),? blepharospasm,? spasticity of the upper limb,? chronic sialorrhea due to neurological disorders,? upper facial lines,- glabellar frown lines,- lateral periorbital lines (crow?s feet),- horizontal forehead lines,xeomin is indicated in children and adolescents aged 2 years to 17 years for the symptomatic treatment of:,? chronic sialorrhea due to neurological/neurodevelopmental disorders,? spasticity of the lower and/or upper limbs

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - botulinum toxin type a - powder for solution for injection - botulinum toxin type a 100 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.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - botulinum toxin type a - powder for solution for injection - botulinum toxin type a 50 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.

Israel - English - 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.

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

abbvie pty ltd - botulinim toxin type a, quantity: 100 u - injection, powder for - excipient ingredients: albumin; sodium chloride - botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following therapeutic indications: treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from a defined neurological illness (such as spinal cord injury or multiple sclerosis) and not controlled adequately by anticholinergic agents. prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine). treatment of strabismus in children and adults.treatment of blepharospasm associated with dystonia, including benign blepharospasm and viith nerve disorders (specifically hemifacial spasm) in patients twelve years and older. treatment of cervical dystonia (spasmodic torticollis). treatment of focal spasticity of the upper and lower limbs, including dynamic equinus foot deformity, due to juvenile cerebral palsy in patients two years and older. treatment of severe primary hyperhidrosis of the axillae. treatment of focal spasticity in adults. treatment of spasmodic dysphonia. botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following cosmetic indications: temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow's feet and forehead lines) in adults.

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

abbvie pty ltd - botulinim toxin type a, quantity: 200 u - injection, powder for - excipient ingredients: albumin; sodium chloride - botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following therapeutic indications: treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication.,treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from a defined neurological illness (such as spinal cord injury or multiple sclerosis) and not controlled adequately by anticholinergic agents.,prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).,treatment of strabismus in children and adults.,treatment of blepharospasm associated with dystonia, including benign blepharospasm and viith nerve disorders (specifically hemifacial spasm) in patients twelve years and older.,treatment of cervical dystonia (spasmodic torticollis).,treatment of focal spasticity of the upper and lower limbs, including dynamic equinus foot deformity, due to juvenile cerebral palsy in patients two years and older.,treatment of severe primary hyperhidrosis of the axillae.,treatment of focal spasticity in adults.,treatment of spasmodic dysphonia.,botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following cosmetic indications: temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow's feet and forehead lines) in adults. botox (botulinum toxin type a) purified neurotoxin complex in indicated for the following therapeutic indications: treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from a defined neurological illness (such as spinal cord injury or multiple sclerosis) and not controlled adequately by anticholinergic agents. this does not include idiopathic overactive bladder. prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine). treatment of strabismus in children and adults.treatment of blepharospasm associated with dystonia, including benign blepharospasm and vii nerve disorders (specifically hemifacial spasm) in patients twelve years and older. treatment of cervical dystonia (spasmodic torticollis). treatment of focal spasticity of the upper and lower limbs, including dynamic equinas foot deformity, due to juvenile cerebral palsy in patients two years of age and older. treatment of severe primary hyperhidrosis of the axillae. treatment of focal spasticity in adults. treatment of spasmodic dysphonia. botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following cosmetic indications: temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow's feet and forehead lines) in adults. botox (botulinum toxin type a) purified neurotoxin complex in indicated for the following therapeutic indications: - prophylaxis of headaches in adults with chronic migraine (headache on at least 15 days per month of which at least 8 days are with migraine); - treatment of strabismus in children and adults; - treatment of blepharospasm associated with dystonia, including benign blepharospasm and vii nerve disorders (specifically hemifacial spasm) in patients twelve years and over; - treatment of cervical dystonia (spasmodic torticollis); - treatment of focal spasticity of the upper and lower limbs, including dynamic equinus foot deformity, due to juvenile cerebral palsy in patients two years of age and older; - treatment of severe primary hyperhidrosis of the axillae; treatment of focal spasticity in adults. - treatment of spasmodic dysphonia. botox (botulinum toxin type a) purified neurotoxin complex in indicated for the following cosmotic indications: temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow-s feet and forehead lines) in adults.

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

abbvie pty ltd - botulinim toxin type a, quantity: 50 u - injection, powder for - excipient ingredients: albumin; sodium chloride - botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following therapeutic indications: treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of an anticholinergic medication. treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from a defined neurological illness (such as spinal cord injury or multiple sclerosis) and not controlled adequately by anticholinergic agents. prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine). treatment of strabismus in children and adults.treatment of blepharospasm associated with dystonia, including benign blepharospasm and viith nerve disorders (specifically hemifacial spasm) in patients twelve years and older. treatment of cervical dystonia (spasmodic torticollis). treatment of focal spasticity of the upper and lower limbs, including dynamic equinus foot deformity, due to juvenile cerebral palsy in patients two years and older. treatment of severe primary hyperhidrosis of the axillae. treatment of focal spasticity in adults. treatment of spasmodic dysphonia. botox (botulinum toxin type a) purified neurotoxin complex is indicated for the following cosmetic indications: temporary improvement in the appearance of upper facial rhytides (glabellar lines, crow's feet and forehead lines) in adults.

European Union - English - EMA (European Medicines Agency)

sloan pharma s.a.r.l - botulinum toxin type b - torticollis - muscle relaxants - neurobloc is indicated for the treatment of cervical dystonia (torticollis).see section 5.1 for data on efficacy in patients responsive / resistant to botulinum toxin type a.

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

croma australia pty ltd - letibotulinumtoxina, quantity: 50 u - injection, powder for - excipient ingredients: sodium chloride; albumin - letybo is indicated for the temporary improvement in the appearance of moderate to severe glabellar frown lines in adults.