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

swisse wellness pty ltd - avena sativa, quantity: 50 mg (equivalent: avena sativa, qty 500 mg); equisetum arvense, quantity: 7.5 mg (equivalent: equisetum arvense, qty 30 mg); vaccinium myrtillus, quantity: 250 microgram (equivalent: vaccinium myrtillus, qty 25 mg; equivalent: anthocyanosides (of vaccinium myrtillus), qty 63 microgram); ubidecarenone, quantity: 1 mg; ferrous fumarate, quantity: 9.61 mg (equivalent: iron, qty 3 mg); selenomethionine, quantity: 65 microgram (equivalent: selenium, qty 26 microgram); centella asiatica, - tablet, film coated - excipient ingredients: silicon dioxide; rosmarinus officinalis; microcrystalline cellulose; hypromellose; magnesium stearate; chlorophyllin-copper complex; acacia; sucrose; pea starch; purified water; colloidal anhydrous silica; sodium alginate; sodium ascorbate; crospovidone; macrogol 400; dl-alpha-tocopherol; titanium dioxide; medium chain triglycerides; maize starch; maltodextrin; macrogol 6000; povidone; peppermint oil - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support collagen formation ; maintain/support collagen health ; maintain/support energy production ; maintain/support physical endurance/capacity/stamina ; maintain/support vitality ; relieve weariness/tiredness/fatigue/feeling of weakness ; maintain/support general health and wellbeing ; aid/assist healthy red blood cell production ; maintain/support red blood cell health ; maintain/support blood health ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; support healthy stress response in the body ; maintain/support cognitive function/mental function ; maintain/support brain function ; maintain/support brain health ; maintain/support nervous system health ; maintain/suppor

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

juniper biologics pty ltd - fosnetupitant chloride hydrochloride, quantity: 260 mg (equivalent: fosnetupitant, qty 235 mg); palonosetron hydrochloride, quantity: 280 microgram (equivalent: palonosetron, qty 250 microgram) - injection, concentrated - excipient ingredients: sodium hydroxide; mannitol; disodium edetate; hydrochloric acid; water for injections - indicated in adult patients for:,prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.,prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

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

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - folic acid, quantity: 95 microgram; calcium pantothenate, quantity: 4 mg; cyanocobalamin, quantity: 50 microgram; pyridoxine hydrochloride, quantity: 5 mg (equivalent: pyridoxine, qty 4.11 mg); calcium ascorbate dihydrate, quantity: 121.04 mg (equivalent: ascorbic acid, qty 100 mg); iron (ii) glycinate, quantity: 18.26 mg (equivalent: iron, qty 5 mg) - tablet, film coated - excipient ingredients: crospovidone; maltodextrin; purified talc; calcium hydrogen phosphate dihydrate; hypromellose; iron oxide red; titanium dioxide; citric acid; microcrystalline cellulose; isomalt; macrogol 6000; macrogol 400; tartaric acid; magnesium stearate; croscarmellose sodium; silicon dioxide - maintain/support energy levels ; maintain/support energy production ; relieve weariness/tiredness/fatigue/feeling of weakness ; aid/assist healthy red blood cell production ; helps maintain/support haemoglobin formation/synthesis ; maintain/support healthy immune system function ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral) within normal range

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

sandoz pty ltd - norethisterone acetate, quantity: 4.8 mg (equivalent: estradiol hemihydrate, qty 0.806 mg; equivalent: norethisterone acetate, qty 250 microgram/24 h); estradiol, quantity: 0.512 mg (equivalent: estradiol, qty 50 microgram/24 h; equivalent: estradiol hemihydrate, qty 0.529 mg) - drug delivery system, transdermal - excipient ingredients: oleic acid; povidone; dipropylene glycol; polytrimethylhydrosilylsiloxane; xylene; ammonia; toluene; 1,1,1-trimethyl-n-(trimethylsilyl)silanamine; dimeticonol; polyethylene terephthalate; polyvinylidene flouride; ethyl acetate; ethanol; acrylates/va copolymer; ethylene/vinyl acetate copolymer - for the short-term treatment of symptoms of oestrogen deficiency in menopausal women who have an intact uterus. combination hrt should not be used in hysterectomised women because it is not needed in these women and it may increase the risk of breast cancer.

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

standard homeopathic company - avena sativa flowering top (unii: ma9cqj3f7f) (avena sativa flowering top - unii:ma9cqj3f7f) - avena sativa flowering top 30 [hp_x] in 1 g - occasional sleeplessness or mental fatigue

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

uriel pharmacy inc. - avena sativa flowering top (unii: ma9cqj3f7f) (avena sativa flowering top - unii:ma9cqj3f7f), ostrea edulis shell (unii: 49oy13be7z) (ostrea edulis shell - unii:49oy13be7z), valerian (unii: jwf5yaw3qw) (valerian - unii:jwf5yaw3qw), phosphorus (unii: 27ylu75u4w) (phosphorus - unii:27ylu75u4w), sulfur (unii: 70fd1kfu70) (sulfur - unii:70fd1kfu70) - avena sativa flowering top 6 [hp_x] in 1 ml - directions: for oral use. uses: temporary relief of nerves and sleeplessness.

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

uriel pharmacy inc - avena sativa flowering top (unii: ma9cqj3f7f) (avena sativa flowering top - unii:ma9cqj3f7f), valerian (unii: jwf5yaw3qw) (valerian - unii:jwf5yaw3qw), ostrea edulis shell (unii: 49oy13be7z) (ostrea edulis shell - unii:49oy13be7z), phosphorus (unii: 27ylu75u4w) (phosphorus - unii:27ylu75u4w), sulfur (unii: 70fd1kfu70) (sulfur - unii:70fd1kfu70) - avena sativa flowering top 3 [hp_x] - directions: for oral use only. use: temporary relief for sleeplessness and nerves.

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

rxhomeo private limited d.b.a. rxhomeo, inc - avena sativa flowering top (unii: ma9cqj3f7f) (avena sativa flowering top - unii:ma9cqj3f7f) - avena sativa flowering top 1 [hp_x] - uses: temporary relief - difficulty falling asleep* * claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated. condition listed above or as directed by the physician

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

rxhomeo private limited d.b.a. rxhomeo, inc - avena sativa flowering top (unii: ma9cqj3f7f) (avena sativa flowering top - unii:ma9cqj3f7f) - avena sativa flowering top 1 [hp_x] - nervous exhaustion condition listed above or as directed by the physician

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

emd serono, inc. - avelumab (unii: kxg2pj551i) (avelumab - unii:kxg2pj551i) - avelumab 20 mg in 1 ml - bavencio (avelumab) is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic merkel cell carcinoma (mcc). first-line maintenance treatment of urothelial carcinoma bavencio is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (uc) that has not progressed with first-line platinum-containing chemotherapy [see clinical studies (14.2)] . previously-treated urothelial carcinoma bavencio is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (uc) who: - have disease progression during or following platinum-containing chemotherapy - have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy [see clinical studies (14.2)]. bavencio in combination with axitinib is indicated for the first-line treatment of patients with advanced renal cell carcinoma (rcc) [see clinical studies (14.3)] . none. risk summary based on its mechanism of action, bavencio can cause fetal harm when administered to a pregnant woman. there are no available data on the use of bavencio in pregnant women [see clinical pharmacology (12.1)] . 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 igg1 immunoglobulins (igg1) are known to cross the placenta. therefore, bavencio has the potential to be transmitted from the mother to the developing fetus. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, 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 animal reproduction studies have not been conducted with bavencio 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 bavencio 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 bavencio may increase the risk of developing immune-related disorders or altering the normal immune response. risk summary there is no information regarding the presence of avelumab in human milk, the effects on the breastfed infant, or the effects on milk production. since many drugs including antibodies are excreted in human milk, advise a lactating woman not to breastfeed during treatment and for at least one month after the last dose of bavencio due to the potential for serious adverse reactions in breastfed infants. contraception based on its mechanism of action, bavencio 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 bavencio and for at least 1 month after the last dose of bavencio. the safety and effectiveness of bavencio have been established in pediatric patients aged 12 years and older for metastatic mcc. use of bavencio in this age group is supported by evidence from adequate and well-controlled studies of bavencio in adults with additional population pharmacokinetic data demonstrating that age and body weight had no clinically meaningful effect on the steady state exposure of avelumab, that drug exposure is generally similar between adults and pediatric patients age 12 years and older for monoclonal antibodies, and that the course of mcc is sufficiently similar in adult and pediatric patients to allow extrapolation of data in adults to pediatric patients. the recommended dose in pediatric patients 12 years of age or greater is the same as that in adults [see dosage and administration (2.2), clinical pharmacology (12.3), and clinical studies (14)] . safety and effectiveness of bavencio have not been established in pediatric patients less than 12 years of age. metastatic merkel cell carcinoma of the 204 patients with mcc who received bavencio in the javelin merkel 200 trial, 78% were 65 years or older and 43% were 75 years or older. no overall differences in safety or efficacy were observed between elderly patients and younger patients. locally advanced or metastatic urothelial carcinoma of the 344 patients randomized to bavencio 10 mg/kg plus bsc in the javelin bladder 100 trial, 63% were 65 years or older and 24% were 75 years or older. no overall differences in safety or efficacy were reported between elderly patients and younger patients. advanced renal cell carcinoma of the 434 patients randomized to bavencio 10 mg/kg administered in combination with axitinib 5 mg twice daily in the javelin renal 101 trial, 38% were 65 years or older and 8% were 75 years or older. no overall difference in safety or efficacy were reported between elderly patients and younger patients.