European Union - English - EMA (European Medicines Agency)

vanda pharmaceuticals netherlands b.v. - tasimelteon - sleep disorders, circadian rhythm - psycholeptics - hetlioz is indicated for the treatment of non-24-hour sleep-wake disorder (non-24) in totally blind adults.,

European Union - English - EMA (European Medicines Agency)

merz pharmaceuticals gmbh   - memantine hydrochloride - alzheimer disease - other anti-dementia drugs - treatment of patients with moderate to severe alzheimer’s disease.

European Union - English - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - multiple sclerosis - selective immunosuppressants - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4.4 and 5.1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

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

takeda pharmaceuticals australia pty ltd - guanfacine hydrochloride, quantity: 4.56 mg - tablet, modified release - excipient ingredients: hypromellose; methacrylic acid - ethyl acrylate copolymer (1:1); sodium lauryl sulfate; polysorbate 80; microcrystalline cellulose; colloidal anhydrous silica; lactose; povidone; crospovidone; glycerol dibehenate; fumaric acid; indigo carmine aluminium lake; iron oxide yellow - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6-17 years old, as monotherapy (when stimulants or atomoxetine are not suitable, not tolerated or have been shown to be ineffective) or as adjunctive therapy to psychostimulants (where there has been a sub-optimal response to psychostimulants).intuniv must be used as part of a comprehensive adhd management programme, typically including psychological, educational and social measures.

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

takeda pharmaceuticals australia pty ltd - guanfacine hydrochloride, quantity: 3.42 mg - tablet, modified release - excipient ingredients: hypromellose; methacrylic acid - ethyl acrylate copolymer (1:1); sodium lauryl sulfate; polysorbate 80; microcrystalline cellulose; colloidal anhydrous silica; lactose; povidone; crospovidone; glycerol dibehenate; fumaric acid; indigo carmine aluminium lake; iron oxide yellow - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6-17 years old, as monotherapy (when stimulants or atomoxetine are not suitable, not tolerated or have been shown to be ineffective) or as adjunctive therapy to psychostimulants (where there has been a sub-optimal response to psychostimulants).intuniv must be used as part of a comprehensive adhd management programme, typically including psychological, educational and social measures.

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

takeda pharmaceuticals australia pty ltd - guanfacine hydrochloride, quantity: 2.28 mg - tablet, modified release - excipient ingredients: hypromellose; methacrylic acid - ethyl acrylate copolymer (1:1); sodium lauryl sulfate; polysorbate 80; microcrystalline cellulose; colloidal anhydrous silica; lactose; povidone; crospovidone; glycerol dibehenate; fumaric acid - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6-17 years old, as monotherapy (when stimulants or atomoxetine are not suitable, not tolerated or have been shown to be ineffective) or as adjunctive therapy to psychostimulants (where there has been a sub-optimal response to psychostimulants).intuniv must be used as part of a comprehensive adhd management programme, typically including psychological, educational and social measures.

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

takeda pharmaceuticals australia pty ltd - guanfacine hydrochloride, quantity: 1.14 mg - tablet, modified release - excipient ingredients: hypromellose; methacrylic acid - ethyl acrylate copolymer (1:1); sodium lauryl sulfate; polysorbate 80; microcrystalline cellulose; colloidal anhydrous silica; lactose; povidone; crospovidone; glycerol dibehenate; fumaric acid - intuniv is indicated for the treatment of attention deficit hyperactivity disorder (adhd) in children and adolescents 6-17 years old, as monotherapy (when stimulants or atomoxetine are not suitable, not tolerated or have been shown to be ineffective) or as adjunctive therapy to psychostimulants (where there has been a sub-optimal response to psychostimulants).intuniv must be used as part of a comprehensive adhd management programme, typically including psychological, educational and social measures.

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

alliance healthcare (distribution) ltd - timolol maleate - eye drops - 2.5mg/1ml

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

alliance healthcare (distribution) ltd - timolol maleate - eye drops - 5mg/1ml

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

phoenix healthcare distribution ltd - timolol maleate - eye drops - 2.5mg/1ml