Iirimaa - inglise - HPRA (Health Products Regulatory Authority)

rosemont pharmaceuticals ltd - simvastatin - oral suspension - 40 mg/5ml - hmg coa reductase inhibitors; simvastatin

Malta - inglise - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - piperacillin, tazobactam, sodium - powder for solution for infusion - piperacillin 2 g tazobactam 0.25 g sodium 130 mg - antibacterials for systemic use

Malta - inglise - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - piperacillin, tazobactam, sodium - powder for solution for infusion - piperacillin 4 g tazobactam 0.5 g sodium 261 mg - antibacterials for systemic use

Austraalia - inglise - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zagro australia pty ltd - levamisole hydrochloride - oral solution/suspension - levamisole hydrochloride anthelmintic active 80.0 g/l - parasiticides

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - trastuzumab emtansine, quantity: 171 mg - injection, powder for - excipient ingredients: sodium hydroxide; sucrose; polysorbate 20; succinic acid - early breast cancer,kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.,metastatic breast cancer,kadcyla, as a single agent, is indicated for the treatment of patients with her2-positive metastatic (stage iv) breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:,? received prior therapy for metastatic disease, or,? developed disease recurrence during or within six months of completing adjuvant therapy.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - trastuzumab emtansine, quantity: 106 mg - injection, powder for - excipient ingredients: sucrose; polysorbate 20; succinic acid; sodium hydroxide - early breast cancer,kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.,metastatic breast cancer,kadcyla, as a single agent, is indicated for the treatment of patients with her2-positive metastatic (stage iv) breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:,? received prior therapy for metastatic disease, or,? developed disease recurrence during or within six months of completing adjuvant therapy.

Ameerika Ühendriigid - inglise - NLM (National Library of Medicine)

aurobindo pharma limited - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate 800 mg - sevelamer carbonate for oral suspension is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. sevelamer carbonate for oral suspension is contraindicated in patients with bowel obstruction. sevelamer carbonate for oral suspension is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. data animal data in pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin d, occurred in mid and high-dose groups (human equivalent doses approximately equal to 3 to 4 times the maximum clinical trial dose of 13 g). in pregnant rabbits given oral doses of 100, 500, or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred in the high-dose group (human equivalent dose twice the maximum clinical trial dose). risk summary sevelamer carbonate is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to sevelamer carbonate. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. the safety and efficacy of sevelamer carbonate in lowering serum phosphorus levels was studied in patients 6 years of age and older with ckd. in this study, sevelamer carbonate was apparently less effective in children with a low baseline serum phosphorus, which described children <13 years of age and children not on dialysis. given its mechanism of action, sevelamer carbonate is expected to be effective in lowering serum phosphorus levels in pediatric patients with ckd. most adverse events that were reported as related, or possibly related, to sevelamer carbonate were gastrointestinal in nature. no new risks or safety signals were identified with the use of sevelamer carbonate in the trial. sevelamer carbonate has not been studied in pediatric patients below 6 years of age. clinical studies of sevelamer carbonate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Suurbritannia - inglise - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - piperacillin sodium; tazobactam sodium - powder for solution for infusion - 2gram ; 250mg

Suurbritannia - inglise - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - piperacillin sodium; tazobactam sodium - powder for solution for infusion - 4gram ; 500mg

Suurbritannia - inglise - MHRA (Medicines & Healthcare Products Regulatory Agency)

clinigen healthcare ltd - aldesleukin - powder for solution for injection - 18mega unit