Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

rad neurim pharmaceuticals eec limited - melatonina - melatonina....2.0 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

arrotex pharmaceuticals (nz) limited - melatonin 2mg;   - modified release tablet - 2 mg - active: melatonin 2mg   excipient: calcium hydrogen phosphate dihydrate colloidal silicon dioxide lactose monohydrate magnesium stearate methacrylic acid copolymer purified talc - indicated as a monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients aged 55 years and over.

European Union - English - EMA (European Medicines Agency)

rad neurim pharmaceuticals eec sarl - melatonin - sleep initiation and maintenance disorders; autistic disorder - psycholeptics - slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (asd) and / or smith-magenis syndrome, where sleep hygiene measures have been insufficient.

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

rad data australia pty ltd - melatonin -

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - melatonin 2mg;  ;   - modified release tablet - 2 mg - active: melatonin 2mg     excipient: ammonio methacrylate copolymer calcium hydrogen phosphate dihydrate colloidal silicon dioxide lactose monohydrate magnesium stearate purified talc - monotherapy for the short term treatment (up to 13 weeks) of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - melatonin 2mg;  ;   - modified release tablet - 2 mg - active: melatonin 2mg     excipient: ammonio methacrylate copolymer calcium hydrogen phosphate dihydrate colloidal silicon dioxide lactose monohydrate magnesium stearate purified talc - monotherapy for the short term treatment (up to 13 weeks) of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

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

generic partners pty ltd - melatonin, quantity: 2 mg - tablet, modified release - excipient ingredients: magnesium stearate; purified talc; colloidal anhydrous silica; calcium hydrogen phosphate dihydrate; lactose monohydrate; ammonio methacrylate copolymer - monotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

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

apotex pty ltd - melatonin, quantity: 2 mg - tablet, modified release - excipient ingredients: ammonio methacrylate copolymer; calcium hydrogen phosphate dihydrate; lactose monohydrate; colloidal anhydrous silica; purified talc; magnesium stearate - monotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.

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

generic partners pty ltd - melatonin, quantity: 2 mg - tablet, modified release - excipient ingredients: ammonio methacrylate copolymer; calcium hydrogen phosphate dihydrate; lactose monohydrate; colloidal anhydrous silica; purified talc; magnesium stearate - monotherapy for the short term treatment of primary insomnia characterized by poor quality of sleep in patients who are aged 55 or over.