European Union - English - EMA (European Medicines Agency)

ceva santé animale - benazepril hydrochloride, spironolactone - cardiovascular system - dogs - for the treatment of congestive heart failure caused by chronic degenerative valvular disease in dogs (with diuretic support as appropriate).

European Union - English - EMA (European Medicines Agency)

ceva sante animale - dinotefuran, pyriproxyfen, permethrin - permethrin, combinations - dogs - treatment and prevention of flea infestation (ctenocephalides felis and ctenocephalides canis).treatment and prevention of tick infestation (rhipicephalus sanguineus, dermacentor reticulatus, ixodes ricinus).prevention of biting from sand flies (phlebotomus perniciosus), mosquitoes (culex pipiens, aedes aegypti) and stable flies (stomoxys calcitrans).treatment of mosquito (aedes aegypti) and stable fly (stomoxys calcitrans) infestation.

European Union - English - EMA (European Medicines Agency)

ceva santé animale - torasemide - high-ceiling diuretics, sulfonamides, plain - dogs - for treatment of clinical signs related to congestive heart failure in dogs, including pulmonary oedema.

Uganda - English - National Drug Authority

astra pharma (uk) ltd - fortified procaine penicillin - parenteral ordinary dry vials - 4000000 iu

Uganda - English - National Drug Authority

gittoes pharmaceuticals limited; gittoes pharmaceuticals limited - fortified procaine penicillin - parenteral ordinary vials - 4 mega units

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

sanofi pasteur inc. - nirsevimab (unii: vrn8s9cw5v) (nirsevimab - unii:vrn8s9cw5v) - beyfortus is indicated for the prevention of respiratory syncytial virus (rsv) lower respiratory tract disease in: beyfortus is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients [see warnings and precautions (5.1) and description (11)] . beyfortus is not indicated for use in females of reproductive potential. beyfortus is not indicated for use in females of reproductive potential. the safety and effectiveness of beyfortus have been established for the prevention of rsv lower respiratory tract disease in neonates and infants born during or entering their first rsv season and in children up to 24 months of age who remain vulnerable to severe rsv disease through their second rsv season. the safety and efficacy of beyfortus for this indication and populations are discussed throughout the labeling. use of beyfortus for this indication is supported by evidence from adequate and well-controlled studies in neonates and infants from birth up to 12 months of age with additional pharmacokinetic and safety data in children up to 24 months of age [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . the safety and effectiveness of beyfortus have not been established in children older than 24 months of age.

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

seagen inc. - enfortumab vedotin (unii: dle8519rwm) (enfortumab vedotin - unii:dle8519rwm) - padcev® , in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (muc). padcev, as a single agent, is indicated for the treatment of adult patients with locally advanced or muc who: none. risk summary based on the mechanism of action and findings in animals, padcev can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available human data on padcev use in pregnant women to inform a drug-associated risk. in an animal reproduction study, administration of enfortumab vedotin-ejfv to pregnant rats during organogenesis caused maternal toxicity, embryo-fetal lethality, structural malformations and skeletal anomalies at maternal exposures similar to the exposures at the recommended human dose of 1.25 mg/kg (see data) . advise patients of the potential risk to the fetus. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. data animal data in a rat pilot embryo-fetal development study, administration of enfortumab vedotin-ejfv on gestation day 6 and 13 during the period of organogenesis resulted in a complete litter loss in all pregnant rats at the maternally toxic dose of 5 mg/kg (approximately 3 times the exposure at the recommended human dose). a dose of 2 mg/kg (similar to the exposure at the recommended human dose) resulted in maternal toxicity, embryo-fetal lethality and structural malformations that included gastroschisis, malrotated hindlimb, absent forepaw, malpositioned internal organs and fused cervical arch. additionally, skeletal anomalies (asymmetric, fused, incompletely ossified, and misshapen sternebrae, misshapen cervical arch, and unilateral ossification of the thoracic centra) and decreased fetal weight were observed. risk summary there are no data on the presence of enfortumab vedotin-ejfv in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with padcev and for 3 weeks after the last dose. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating padcev treatment [see use in specific populations (8.1)] . contraception females padcev can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with padcev and for 2 months after the last dose. males advise male patients with female partners of reproductive potential to use effective contraception during treatment with padcev and for 4 months after the last dose. infertility females based on findings in animal studies with mmae-containing antibody-drug conjugates (adcs), padcev may impair female fertility. the effect on fertility is reversible [see nonclinical toxicology (13.1)] . males based on findings from animal studies, padcev may impair male fertility [see nonclinical toxicology (13.1)] . safety and effectiveness of padcev in pediatric patients have not been established. of the 564 patients treated with padcev in combination with pembrolizumab, 44% (n=247) were 65-74 years and 26% (n=144) were 75 years or older. of the 720 patients treated with padcev as a single agent in clinical trials, 39% (n=282) were 65-74 years and 24% (n=170) were 75 years or older. no overall differences in effectiveness were observed between patients 65 years of age or older and younger patients. patients 75 years of age or older treated with padcev in combination with pembrolizumab experienced a higher incidence of fatal adverse reactions than younger patients. the incidence of fatal adverse reactions was 4% in patients younger than 75 and 7% in patients 75 years or older. patients 75 years of age or older treated with padcev as a single agent experienced a higher incidence of fatal adverse reactions than younger patients. the incidence of fatal adverse reactions was 6% in patients younger than 75 years, and 11% in patients 75 years or older. no significant difference was observed in the pharmacokinetics of padcev between patients 65 years and older and younger patients [see clinical pharmacology (12.3 )]. avoid the use of padcev in patients with moderate or severe hepatic impairment (total bilirubin >1.5 x uln and ast any). padcev has only been studied in a limited number of patients with moderate hepatic impairment (n=3) and has not been evaluated in patients with severe hepatic impairment [see clinical pharmacology (12.3)] . in another adc that contains mmae, the frequency of ≥ grade 3 adverse reactions and deaths was greater in patients with moderate (child-pugh b) or severe (child-pugh c) hepatic impairment compared to patients with normal hepatic function.

European Union - English - EMA (European Medicines Agency)

ceva santé animale - pyriproxyfen, dinotefuran - antiparasitic products, insecticides and repellents, other ectoparasiticides for topical use, pyriproxyfen, combinations - cats - treatment and prevention of flea infestations (ctenocephalides felis) on cats.one application prevents flea infestation for one month. it also prevents the multiplication of fleas by inhibiting flea emergence in the environment of the cat for 3 months.

Ireland - English - HPRA (Health Products Regulatory Authority)

ceva santé animale - eprinomectin - solution for injection - 20 milligram(s)/millilitre - eprinomectin - cattle - endectoparasiticides

Ireland - English - HPRA (Health Products Regulatory Authority)

ceva santé animale - febantel; pyrantel ; praziquantel - tablet - 525,175,175 mg/tablet - praziquantel, combinations - dogs - endoparasiticide