फ़िलिपींस - अंग्रेज़ी - FDA (Food And Drug Administration)

dyna drug corporation; importer: n/a; distributor: n/a - colchicine - tablet - 500 mcg

फ़िलिपींस - अंग्रेज़ी - FDA (Food And Drug Administration)

dyna drug corporation; importer: n/a; distributor: n/a - mefenamic acid - capsule - 500 mg

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - parecoxib sodium -

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - parecoxib sodium 21.18mg equivalent to 20 mg parecoxib;   - powder for injection - 20 mg - active: parecoxib sodium 21.18mg equivalent to 20 mg parecoxib   excipient: dibasic sodium phosphate heptahydrate nitrogen phosphoric acid sodium hydroxide hydrochloric acid nitrogen sodium chloride sodium hydroxide water for injection - for a single peri-operative dose for the management of post-operative pain.

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - parecoxib sodium 42.36mg equivalent to 40 mg parecoxib;   - powder for injection - 40 mg - active: parecoxib sodium 42.36mg equivalent to 40 mg parecoxib   excipient: dibasic sodium phosphate heptahydrate nitrogen phosphoric acid sodium hydroxide hydrochloric acid nitrogen sodium chloride sodium hydroxide water for injection - for a single peri-operative dose for the management of post-operative pain.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - panobinostat lactate (unii: hn0t99oo4v) (panobinostat - unii:9647fm7y3z) - panobinostat 10 mg - farydak, a histone deacetylase inhibitor, in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. this indication is approved under accelerated approval based on progression free survival [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. none risk summary farydak can cause fetal harm when administered to a pregnant woman. panobinostat was teratogenic in rats and rabbits. if farydak is used during pregnancy or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus. data animal data in embryofetal development studies, panobinostat was administered orally 3 times per week during the period of organogenesis to pregnant rats (30, 100, and 300 mg/kg) and rabbits (10, 40, and 80 mg/kg). i

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

genzyme corporation - vandetanib (unii: yo460oq37k) (vandetanib - unii:yo460oq37k) - vandetanib 100 mg - caprelsa is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. use caprelsa in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of caprelsa. do not use in patients with congenital long qt syndrome [see boxed warning] . risk summary based on its mechanism of action and findings in animals, caprelsa can cause fetal harm when administered to a pregnant woman. there are no available human data on caprelsa use in pregnant women to inform a drug-associated risk. vandetanib is embryotoxic, fetotoxic, and induced fetal malformations in rats at exposures less than or equal to those expected at the recommended human dose of 300 mg/day. advise patients 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 reproductive toxicity studies, administration of vandetanib to female rats prior to mating and through the first week of pregnancy at a dose of 25 mg/kg/day (approximately equal to the human exposure at the 300 mg clinical dose based on cmax ), there were increases in pre-implantation loss and post-implantation loss resulting in a reduction in the number of live embryos. during organogenesis, vandetanib caused an increase in post-implantation loss, including occasional total litter loss at a dose of 25 mg/kg/day. at doses greater than 10 mg/kg/day (approximately 0.4 times the human cmax at the 300 mg clinical dose) treatment with vandetanib resulted in increases in late embryofetal death and decreases in fetal birth weight. a no-effect level for malformations was not identified in this study. administration of vandetanib at doses greater than or equal to 1 mg/kg/day (approximately 0.03 times the human cmax at the 300 mg clinical dose) resulted in dose dependent increases in both malformations of the heart vessels and skeletal variations including delayed ossification of the skull, vertebrae, and sternum, indicating delayed fetal development. in a rat prenatal and postnatal development study, at doses (1 and 10 mg/kg/day) producing mild maternal toxicity during gestation and/or lactation, vandetanib decreased pup survival and reduced postnatal pup growth. reduced postnatal pup growth was associated with a delay in physical development. risk summary there are no data on the presence of vandetanib or its metabolites in human milk, the effects on the breastfed child or on milk production. vandetanib was present in the milk of lactating rats (see data) . because of the potential for serious adverse reactions from caprelsa in breastfed children, advise lactating women not to breastfeed during treatment with caprelsa and for 4 months after the last dose. data animal data in nonclinical studies, vandetanib was excreted in rat milk and found in plasma of pups following dosing to lactating rats. vandetanib transfer in breast milk resulted in relatively constant exposure in pups due to the long half-life of the drug. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating treatment with caprelsa [see use in specific populations (8.1)] . contraception caprelsa can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . females advise females of reproductive potential to use effective contraception during treatment with caprelsa and for 4 months after the last dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with caprelsa and for 4 months after the last dose. infertility there are no data on the effect of caprelsa on human fertility. results from animal studies indicate that vandetanib can impair male and female fertility [see nonclinical toxicology (13.1)] . safety and efficacy of caprelsa in pediatric patients have not been established. the mtc study of caprelsa did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently compared to younger patients. vandetanib exposure is increased in patients with impaired renal function. reduce the starting dose to 200 mg in patients with moderate (creatinine clearance ≥30 to <50 ml/min) renal impairment [see dosage and administration (2.1), warnings and precautions (5.12), and clinical pharmacology (12.3)] . vandetanib is not recommended for use in patients with severe renal impairment (clearance below 30 ml/min) [see warnings and precautions (5.12)] . patients with end-stage renal disease requiring dialysis were not studied [see adverse reactions (6.1)] . the pharmacokinetics of caprelsa were evaluated after a single dose of 800 mg in subjects with mild (n=8), moderate (n=7), and severe (n=6) hepatic impairment and normal hepatic function (n=5). subjects with mild (child-pugh class a), moderate (child-pugh class b), and severe (child-pugh class c) hepatic impairment had comparable mean auc and clearance values to those with normal hepatic function. there are limited data in patients with liver impairment (serum bilirubin greater than 1.5 times the upper limit of normal). caprelsa is not recommended for use in patients with moderate and severe hepatic impairment, as safety and efficacy have not been established [see dosage and administration (2.1) and warnings and precautions (5.13)] .

मलेशिया - अंग्रेज़ी - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dynapharm (m) sdn bhd - white soft paraffin; liquid paraffin; cetomacrogol emulsifying wax -

मलेशिया - अंग्रेज़ी - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

dynapharm (m) sdn bhd - calamine -

मलेशिया - अंग्रेज़ी - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

izuhan pharmacy sdn bhd - ascorbic acid -