New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - citalopram hydrobromide 49.96mg equivalent to to 40 mg citralopram - film coated tablet - 40 mg - active: citalopram hydrobromide 49.96mg equivalent to to 40 mg citralopram excipient: croscarmellose sodium glycerol hypromellose e-5 lactose monohydrate macrogol 400 magnesium stearate maize starch microcrystalline cellulose povidone titanium dioxide

New Zealand - engelsk - 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 - engelsk - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - irinotecan hydrochloride trihydrate 20 mg/ml ((equivalent to 17.33 mg irinotecan));   - solution for infusion - 20 mg/ml - active: irinotecan hydrochloride trihydrate 20 mg/ml ((equivalent to 17.33 mg irinotecan))   excipient: hydrochloric acid lactic acid sodium hydroxide sorbitol water for injection - irinotecan hydrochloride trihydrate injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum, in combination with 5fu/leucovorin. irinotecan hydrochloride trihydrate injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - nitrazepam 5mg;   - tablet - 5 mg - active: nitrazepam 5mg   excipient: lactose monohydrate magnesium stearate maize starch - nitrazepam is indicated in adults for: · short term treatment of insomnia when it is severe, disabling or subjecting the individual to unacceptable distress, where daytime insomnia is acceptable.

Irland - engelsk - HPRA (Health Products Regulatory Authority)

pharmaceuticals sales & development sweden ab (pharmswed) - apomorphine hydrochloride hemihydrate - solution for infusion - 5 milligram(s)/millilitre - dopamine agonists; apomorphine

Singapore - engelsk - HSA (Health Sciences Authority)

mundipharma pharmaceuticals pte. ltd. (uen 200411241w) - tapentadol hydrochloride 58.24 mg eqv tapentadol - tablet, film coated - 50 mg - tapentadol hydrochloride 58.24 mg eqv tapentadol 50 mg

Singapore - engelsk - HSA (Health Sciences Authority)

mundipharma pharmaceuticals pte. ltd. (uen 200411241w) - tapentadol hydrochloride 87.36 mg eqv tapentadol - tablet, film coated - 75 mg - tapentadol hydrochloride 87.36 mg eqv tapentadol 75 mg

Irland - engelsk - HPRA (Health Products Regulatory Authority)

aspen pharma trading limited - propofol - emulsion for injection/infusion - 1 percent weight/volume - other general anesthetics; propofol

Den europeiske union - engelsk - EMA (European Medicines Agency)

takeda pharma a/s - fentanyl citrate - pain; cancer - analgesics - instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Den europeiske union - engelsk - EMA (European Medicines Agency)

amneal pharma europe ltd - levodopa, carbidopa - parkinson disease - anti-parkinson drugs - symptomatic treatment of adult patients with parkinson’s disease