Ireland - English - HMA (Heads of Medicines Agencies)

janssen animal health bvba - flubendazole 100 mg/g - oral emulsion - chicken, pigs - flubendazole

Italy - English - HMA (Heads of Medicines Agencies)

janssen animal health bvba - flubendazole 100 mg/g - oral emulsion - chicken, pigs - flubendazole

Portugal - English - HMA (Heads of Medicines Agencies)

janssen animal health bvba - flubendazole 100 mg/g - oral emulsion - chicken, pigs - flubendazole

United Kingdom - English - HMA (Heads of Medicines Agencies)

janssen animal health bvba - flubendazole 100 mg/g - oral emulsion - chicken, pigs - flubendazole

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

johnson & johnson sdn bhd - rad26.cov2-s -

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

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

janssen biotech, inc. - teclistamab (unii: 54534mx6z9) (teclistamab - unii:54534mx6z9) - tecvayli is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-cd38 monoclonal antibody. this indication is approved under accelerated approval based on response rate [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary based on the mechanism of action, tecvayli may cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on the use of tecvayli in pregnant women to evaluate for a drug associated risk. no animal reproductive or developmental toxicity studies have been conducted with tecvayli. teclistamab-cqyv causes t-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. human immunoglobulin g (igg) is known to cross the placenta; therefore, teclistamab-cqyv has the potential to be transmitted from the mother to the developing fetus. advise women of the potential risk to the fetus. tecvayli is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with tecvayli should be considered. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there are no data on the presence of teclistamab-cqyv in human milk, the effect on the breastfed child, or the effects on milk production. maternal igg is known to be present in human milk. the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to tecvayli are unknown. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with tecvayli and for 5 months after the last dose. tecvayli may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status of females of reproductive potential prior to initiating tecvayli. contraception females advise females of reproductive potential to use effective contraception during treatment and for 5 months after the last dose of tecvayli. the safety and efficacy of tecvayli have not been established in pediatric patients. of the 165 patients with relapsed or refractory multiple myeloma treated with tecvayli in majestec-1 at the recommended dosage, 48% were 65 years of age or older, and 15% were 75 years of age or older. no overall differences in safety or effectiveness were observed between patients 65 to 74 years of age compared to younger patients. there is an insufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

janssen pharmaceutica n.v. - propiconazole - emulsifiable concentrate - propiconazole triazole active 250.0 g/l - fungicide - mushroom bed | mushroom growing tray - control adhesion of mushroom mycelium | allow easy tip out of compost | tray

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - golimumab 50mg;   - solution for injection - 50 mg - active: golimumab 50mg   excipient: histidine polysorbate 80 sorbitol water for injection - rheumatoid arthritis: simponi, in combination with mtx, is indicated for: · the treatment of active rheumatoid arthritis in adult patients when the response to dmard therapy has been inadequate. · the treatment of active rheumatoid arthritis in adult patients not previously treated with mtx. simponi has also been shown to reduce the rate of progression of joint damage as measured by x-ray, improve physical function and health related quality of life. simponi can be used in patients previously treated with one or more tnf inhibitor(s).

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - golimumab 50mg;   - solution for injection - 50 mg - active: golimumab 50mg   excipient: histidine polysorbate 80 sorbitol water for injection - rheumatoid arthritis: simponi, in combination with mtx, is indicated for: · the treatment of active rheumatoid arthritis in adult patients when the response to dmard therapy has been inadequate. · the treatment of active rheumatoid arthritis in adult patients not previously treated with mtx. simponi has also been shown to reduce the rate of progression of joint damage as measured by x-ray, improve physical function and health related quality of life. simponi can be used in patients previously treated with one or more tnf inhibitor(s).