India - English - Central Drugs Standard Control Organization

ajanta ph. - efflornithine hcl. - tube - 13.9% - 10g

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

physicians total care, inc. - eflornithine hydrochloride (unii: 4nh22ndw9h) (eflornithine - unii:zqn1g5v6sr) - eflornithine hydrochloride anhydrous 139 mg in 1 g - vaniqa (eflornithine hydrochloride) cream, 13.9% is indicated for the reduction of unwanted facial hair in women. vaniqa has only been studied on the face and adjacent involved areas under the chin of affected individuals. usage should be limited to these areas of involvement. vaniqa is contraindicated in patients with a history of sensitivity to any components of the preparation.

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

allergan, inc. - eflornithine hydrochloride (unii: 4nh22ndw9h) (eflornithine - unii:zqn1g5v6sr) - eflornithine hydrochloride anhydrous 139 mg in 1 g - vaniqa ®   (eflornithine hydrochloride) cream, 13.9% is indicated for the reduction of unwanted facial hair in women. vaniqa ® has only been studied on the face and adjacent involved areas under the chin of affected individuals. usage should be limited to these areas of involvement. vaniqa ® is contraindicated in patients with a history of sensitivity to any components of the preparation.

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

a menarini australia pty ltd - eflornithine hydrochloride -

Israel - English - Ministry of Health

medison pharma ltd - eflornithine as hydrochloride monohydrate - cream - eflornithine as hydrochloride monohydrate 11.5 %w/w - eflornithine - eflornithine - vaniqa is indicated for the reduction of unwanted facial hair in women.

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

pella pharmaceuticals co. ltd - eflornithine hydrochloride (unii: 4nh22ndw9h) (eflornithine - unii:zqn1g5v6sr) - florexa is indicated for the reduction of unwanted facial hair in women. florexa has only been studied on the face and adjacent involved areas under the chin of affected individuals. usage should be limited to these areas of involvement. eflomithine hcl is contraindicated in patients with a history of sensitivity to any components of the preparation. children less than 12 years of age shouldn't use florexa .

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - eflornithine hydrochloride monohydrate 13.9% - topical cream - 13.9 % - active: eflornithine hydrochloride monohydrate 13.9% excipient: dimeticone glyceryl stearate + polyoxyl 100 stearate cetostearyl alcohol + ceteareth-20 liquid paraffin methyl hydroxybenzoate phenoxyethanol propyl hydroxybenzoate purified water stearyl alcohol

European Union - English - EMA (European Medicines Agency)

almirall, s.a. - eflornithine - hirsutism - other dermatological preparations - treatment of facial hirsutism in women.

Canada - English - Health Canada

cipher pharmaceuticals inc - eflornithine hydrochloride - cream - 13.9% - eflornithine hydrochloride 13.9% - misc. skin and mucous membrane agents

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

uswm, llc - eflornithine hydrochloride (unii: 4nh22ndw9h) (eflornithine - unii:zqn1g5v6sr) - iwilfin (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (hrnb) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-gd2 immunotherapy. none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1) ], iwilfin can cause fetal harm when administered to a pregnant woman. in animal reproduction studies, oral administration of eflornithine to pregnant rats and rabbits during the period of organogenesis resulted in embryolethality at doses equivalent to the recommended human dose [see data] . there are no available data on the use of iwilfin in pregnant women. advise pregnant women and females of reproductive potential 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 in an embryo-fetal development study, once daily oral administration of 30, 80 or 200 mg/kg/day eflornithine to pregnant rats during the period of organogenesis (gestation day 6 to 7) resulted in reduced fetal body weights and an increase in the incidence of skeletal variations (presence of a 14th rudimentary rib, 14th full rib, 27th presacral vertebrae) at 200 mg/kg/day [approximately 0.8 to 2 times the recommended human dose of 1152 ± 384 mg/m2 /day based on body surface area (bsa)]. in a dose range-finding embryo-fetal development study, pregnant rats receiving oral administration of up to 2000 mg/kg/day eflornithine during the period of organogenesis exhibited increased early resorptions and post-implantation loss beginning at 300 mg/kg/day (approximately 1 to 2 times the recommended human dose of 1152 ± 384 mg/m2 /day based on bsa), with 100% post-implantation loss and no viable fetuses at ≥800 mg/kg/day (approximately ≥3 to 6 times the recommended human dose of 1152 ± 384 mg/m2 /day based on bsa). in an embryo-fetal development study in rabbits, once daily oral administration of 15, 45 or 135 mg/kg/day eflornithine to pregnant animals during the period of organogenesis (gestation day 7 to 20) resulted in reduced gravid uterine weight accompanied by increased pre-implantation and post-implantation loss, increased early resorptions, and reduced fetal body weights at 135 mg/kg/day (approximately 1 to 2 times the recommended human dose of 1152 ± 384 mg/m2 /day based on bsa). eflornithine resulted in abortions in one animal at 15 mg/kg/day (approximately 0.1 to 0.2 times the recommended human dose of 1152 ± 384 mg/m2 /day based on bsa) and one animal at 135 mg/kg/day. in a dose range-finding embryo-fetal development study, pregnant rabbits receiving oral administration of up to 500 mg/kg/day eflornithine during the period of organogenesis exhibited 100% post-implantation loss and no viable fetuses at 500 mg/kg/day (approximately 4 to 8 times the recommended human dose of 1152 ± 384 mg/m2 /day based on bsa). there was no clear evidence of eflornithine-related fetal malformations in rats or rabbits. risk summary there are no data on the presence of eflornithine in human milk, the effects on the breastfed child, or on milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with iwilfin and for 1 week after the last dose. based on animal data and its mechanism of action, iwilfin 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 iwilfin [see use in specific populations (8.1)] . contraception females advise females of reproductive potential to use effective contraception during treatment with iwilfin and for 1 week after the last dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with iwilfin and for 1 week after the last dose. the safety and effectiveness of iwilfin have been established to reduce the risk of relapse in pediatric patients with high-risk neuroblastoma (hrnb) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-gd2 immunotherapy. use of iwilfin for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients with a median age of 4 years (range: 1 to 17) [see adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)]. the safety and effectiveness of iwilfin have not been established in pediatric patients for other indications [see indications and usage (1)].