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

janssen-cilag pty ltd - guselkumab, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; histidine; sucrose; polysorbate 80; histidine hydrochloride monohydrate - plaque psoriasis,tremfya is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,tremfya is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior dmard therapy.

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

janssen-cilag pty ltd - guselkumab, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; sucrose; histidine hydrochloride monohydrate; histidine; polysorbate 80 - plaque psoriasis,tremfya is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.,psoriatic arthritis,tremfya is indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior dmard therapy.

European Union - English - EMA (European Medicines Agency)

h. lundbeck a/s - nalmefene hydrochloride dihydrate - alcohol-related disorders - drugs used in alcohol dependence - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - selumetinib -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

astrazeneca sdn. bhd. - selumetinib -

Malta - English - Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 200 mg - all other therapeutic products

Malta - English - Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 500 mg - all other therapeutic products

United States - English - NLM (National Library of Medicine)

janssen biotech, inc. - guselkumab (unii: 089658a12d) (guselkumab - unii:089658a12d) - guselkumab 100 mg in 1 ml - tremfya is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. tremfya is indicated for the treatment of adult patients with active psoriatic arthritis. tremfya is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see warnings and precautions (5.1)] . pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to tremfya during pregnancy. patients should be encouraged to enroll in the registry by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing mothertobaby@health.ucsd.edu. risk summary there are no available data on tremfya use in pregnant women to inform a drug associated risk of adverse developmental outcomes. human igg antibodies are known to cross the placental barrier; therefore, tremfya may be transmitted from the mother to the devel

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

alphapharm pty ltd - selegiline hydrochloride -

Ireland - English - HPRA (Health Products Regulatory Authority)

pharma regulatory solutions ltd - voriconazole - pdr for soln for infusion - 200 milligram - triazole derivatives - antimycotics for systemic use, triazole derivatives - voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis. treatment of candidaemia in non-neutropenic patients. treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). treatment of serious fungal infections caused by scedosporium spp. and fusarium spp. voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients.