European Union - English - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - regdanvimab - covid-19 virus infection - immune sera and immunoglobulins, - regdanvimab is indicated for the treatment of adults with coronavirus disease 2019 (covid-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19.

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

celltrion healthcare australia pty ltd - regdanvimab, quantity: 60 mg/ml - injection, concentrated - excipient ingredients: polysorbate 80; water for injections; histidine hydrochloride monohydrate; histidine; arginine hydrochloride - regkirona has provisional approval for the treatment of adults with coronavirus disease 2019 (covid-19) who do not require supplemental oxygen and are at increased risk of progressing to severe covid-19 (see section 5.1 pharmacodynamic properties, clinical trials).,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from assessment.

United Arab Emirates - English - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

regdanvimab -

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

incyte corporation - retifanlimab (unii: 2y3t5if01z) (retifanlimab - unii:2y3t5if01z) - zynyz is indicated for the treatment of adult patients with metastatic or recurrent locally advanced merkel cell carcinoma (mcc). this indication is approved under accelerated approval based on tumor response rate and duration of response. continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials [see clinical studies (14)] . none. risk summary based on its mechanism of action, zynyz can cause fetal harm when administered to a pregnant woman [see clinical pharmacology ( 12.1 )] . there are no available data on the use of zynyz in pregnant women. animal studies have demonstrated that inhibition of the pd‑1/pd‑l1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see data ). human igg4 immunoglobulins (igg4) are known to cross the placenta; therefore, retifanlimab-dlwr has the potential to be transmitted from the mother to the developing fetus. advise women of the potential risk to a fetus. 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. data animal data animal reproduction studies have not been conducted with zynyz to evaluate its effect on reproduction and fetal development. a central function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. in murine models of pregnancy, blockade of pd-l1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering zynyz during pregnancy include increased rates of abortion or stillbirth. as reported in the literature, there were no malformations related to the blockade of pd-1/pd-l1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in pd-1 and pd-l1 knockout mice. based on its mechanism of action, fetal exposure to retifanlimab-dlwr may increase the risk of developing immune-mediated disorders or altering the normal immune response. risk summary there is no information regarding the presence of retifanlimab-dlwr in human milk, or its effects on the breastfed child or 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 zynyz are unknown. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 4 months after the last dose of zynyz. zynyz can cause fetal harm when administered to a pregnant woman [see use in specific populations ( 8.1 )] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating zynyz [see use in specific populations ( 8.1 )] . contraception advise females of reproductive potential to use effective contraception during treatment with zynyz and for 4 months after the last dose. the safety and effectiveness of zynyz have not been established in pediatric patients. of the 65 patients with metastatic or recurrent locally advanced mcc treated with zynyz, 79% were 65 years or older, and 37% were 75 years or older. clinical studies of zynyz did not include sufficient numbers of younger adult patients to determine if patients 65 years of age and older respond differently than younger adult patients.

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

bristol-myers squibb australia pty ltd - nivolumab, quantity: 255.6 mg; relatlimab, quantity: 85.2 mg - injection, concentrated - excipient ingredients: histidine hydrochloride monohydrate; water for injections; pentetic acid; sucrose; polysorbate 80; histidine - opdualag is indicated for the treatment of patients with unresectable or metastatic melanoma who are at least 12 years old.

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

e.r. squibb & sons, l.l.c. - nivolumab (unii: 31yo63lbsn) (nivolumab - unii:31yo63lbsn), relatlimab (unii: af75xof6w3) (relatlimab - unii:af75xof6w3) - opdualag™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. none.       risk summary based on findings in animals and mechanism of action, opdualag can cause fetal harm when administered to a pregnant woman. administration of nivolumab to cynomolgus monkeys from the onset of organogenesis through delivery resulted in increased abortion and premature infant death (see data ). human igg4 is known to cross the placenta; therefore, nivolumab and relatlimab have the potential to be transmitted from the mother to the developing fetus. the effects of opdualag are likely to be greater during the second and third trimesters of pregnancy. there are no available data on opdualag in pregnant women to evaluate a drug-associated risk. advise the patient of the potential risk to a fetus. 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. data animal data opdualag injection for intravenous use contains nivolumab and relatlimab [see description (11)] . nivolumab: one function of the pd-1/pd-l1 pathway is to preserve pregnancy by maintaining immune tolerance to the fetus. the effects of nivolumab on prenatal and postnatal development were evaluated in monkeys that received nivolumab twice weekly from the onset of organogenesis through delivery, at exposure levels of between 9 and 42 times higher than those observed at the clinical dose of 3 mg/kg (based on auc). nivolumab administration resulted in a non-dose-related increase in spontaneous abortion and increased neonatal death. in surviving infants (18 of 32 compared to 11 of 16 vehicle-exposed infants) of cynomolgus monkeys treated with nivolumab, there were no apparent malformations and no effects on neurobehavioral, immunological, or clinical pathology parameters throughout the 6-month postnatal period. relatlimab: there are no available animal data on relatlimab. the effects of a murine surrogate anti-lag-3 antibody was evaluated in mice using syngeneic and allogeneic breeding models. when anti-lag-3 antibodies were administered beginning on gestation day 6, there were no maternal or developmental effects in either syngeneic or allogeneic breedings. risk summary there are no data on the presence of nivolumab and relatlimab in human milk, the effects on the breastfed child, or the effects on milk production. because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with opdualag and for at least 5 months after the last dose [see pharmacokinetics (12.3)] . opdualag can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating opdualag [see use in specific populations (8.1)] . contraception advise females of reproductive potential to use effective contraception during treatment and for at least 5 months following the last dose of opdualag [see clinical pharmacology (12.3)] . the safety and effectiveness of opdualag for the treatment of unresectable or metastatic melanoma have been established in pediatric patients 12 years of age or older who weigh at least 40 kg. use of opdualag for this indication is supported by evidence from an adequate and well-controlled study in adults and additional data analyses that suggest that nivolumab and relatlimab exposures in pediatric patients 12 years of age who weigh at least 40 kg are expected to result in similar safety and efficacy to that of adults. the pharmacokinetics of monoclonal antibodies and the course of unresectable or metastatic melanoma are sufficiently similar in adults and pediatric patients 12 years of age or older to allow extrapolation of data from adult patients to pediatric patients 12 years of age or older (who weigh at least 40 kg). a recommended dosage for pediatric patients 12 years of age or older who weigh less than 40 kg has not been established [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the safety and effectiveness of opdualag have not been established in pediatric patients 12 years of age or older who weigh less than 40 kg, and pediatric patients younger than 12 years of age. of the 355 patients treated with opdualag in relativity-047, 47% of patients were 65 years or older, 29% were 65 to 74 years, 17% were 75 to 84 years, and 1.7% were 85 years and older. no overall differences in safety or effectiveness were observed between elderly patients and younger patients.

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab, relatlimab - melanoma - antineoplastic agents, monoclonal antibodies - opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell pd l1 expression < 1%.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - nivolumab; relatlimab - concentrate for solution for infusion - relatlimab 4 mg/ml; nivolumab 12 mg/ml - nivolumab - opdualag is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

Singapore - English - HSA (Health Sciences Authority)

bristol-myers squibb (singapore) pte. ltd. - nivolumab; relatlimab - infusion, solution concentrate - nivolumab 240mg per vial; relatlimab 80mg per vial