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.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - dexamethasone - implant in applicator - dexamethasone 0.7 mg - dexamethasone - dexamethasone - ozurdex is indicated for the treatment of adult patients with:• diabetic macular oedema (dme)• macular oedema following either branch retinal vein occlusion (brvo) or central retinal vein occlusion (crvo).• inflammation of the posterior segment of the eye presenting as non-infectious uveitis.

Israel - English - Ministry of Health

abbvie biopharmaceuticals ltd, israel - bimatoprost; timolol as maleate - eye drops, solution - bimatoprost 0.3 mg/ml; timolol as maleate 5 mg/ml - timolol - timolol - reduction of intraocular pressure in patients with open- angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

Ireland - English - HPRA (Health Products Regulatory Authority)

vale pharmaceuticals ltd - flucloxacillin sodium - pdr for soln inj/inf - 250 milligram - beta-lactamase resistant penicillins

Ireland - English - HPRA (Health Products Regulatory Authority)

vale pharmaceuticals ltd - flucloxacillin sodium - pdr for soln inj/inf - 500 milligram - beta-lactamase resistant penicillins

Ireland - English - HPRA (Health Products Regulatory Authority)

vale pharmaceuticals ltd - flucloxacillin sodium - pdr for soln inj/inf - 1000 milligram - beta-lactamase resistant penicillins

Ireland - English - HPRA (Health Products Regulatory Authority)

vale pharmaceuticals ltd - flucloxacillin sodium - pdr for soln inj/inf - 2000 milligram - beta-lactamase resistant penicillins

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

a a h pharmaceuticals ltd - hypromellose - eye drops - 3mg/1ml