European Union - English - EMA (European Medicines Agency)

cangene europe limited - human hepatitis b immunoglobulin - immunization, passive; hepatitis b - specific immunoglobulins - immunoprophylaxis of hepatitis b - in case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown).- in haemodialysed patients, until vaccination has become effective.- in the newborn of a hepatitis b virus carrier-mother.- in subjects who did not show an immune response (no measurable hepatitis b antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis b.consideration should also be given to other official guidance on the appropriate use of human hepatitis b immunoglobulin for intramuscular use.

Israel - English - Ministry of Health

cts ltd - baclofen - solution for infusion - baclofen 2 mg/ml - baclofen - baclofen sintetica is indicated in patients with severe chronic spasticity resulting from trauma, multiple sclerosis or other spinal cord disorders, who are unresponsive to oral baclofen or other orally administered antispastic agents and/or those patients who experience unacceptable side effects at effective oral doses.baclofen sintetica is effective in adult patients with severe chronic spasticity of cerebral origin, resulting e.g. from cerebral palsy, brain trauma or cerebrovascular accident; however, clinical experience is limited.paediatric population: baclofen sintetica indicated in patients aged 4 to <18 years with severe chronic spasticity of cerebral origin or of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Israel - English - Ministry of Health

cts ltd - baclofen - solution for infusion - baclofen 0.5 mg / 1 ml - baclofen - baclofen sintetica is indicated in patients with severe chronic spasticity resulting from trauma, multiple sclerosis or other spinal cord disorders, who are unresponsive to oral baclofen or other orally administered antispastic agents and/or those patients who experience unacceptable side effects at effective oral doses.baclofen sintetica is effective in adult patients with severe chronic spasticity of cerebral origin, resulting e.g. from cerebral palsy, brain trauma or cerebrovascular accident; however, clinical experience is limited.paediatric population: baclofen sintetica indicated in patients aged 4 to <18 years with severe chronic spasticity of cerebral origin or of spinal origin (associated with injury, multiple sclerosis, or other spinal cord diseases) who are unresponsive to orally administered antispastics (including oral baclofen) and/or who experience unacceptable side effects at effective oral doses.

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios liconsa, s.a. - losartan potassium - film coated tablet - 50 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios liconsa, s.a. - losartan potassium - film coated tablet - 100 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

laboratorios liconsa, s.a. - losartan potassium - film coated tablet - 12.5 milligram

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - donepezil hydrochloride - film-coated tablet - 10 milligram(s) - anticholinesterases; donepezil

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - donepezil hydrochloride - film-coated tablet - 5 milligram(s) - anticholinesterases; donepezil

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - baclofen 10mg - tablet - 10 mg - active: baclofen 10mg excipient: calcium hydrogen phosphate colloidal silicon dioxide lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate - spasticity of the skeletal muscles in multiple sclerosis. spastic conditions occurring in spinal-cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin: e.g. spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord; muscle spasm of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

noumed pharmaceuticals limited - baclofen 10mg - tablet - 10 mg - active: baclofen 10mg excipient: colloidal silicon dioxide magnesium stearate maize starch microcrystalline cellulose povidone - " spasticity of the skeletal muscles in multiple sclerosis. " spastic conditions occurring in spinal-cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin: e.g. spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord; muscle spasm of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease.