European Union - English - EMA (European Medicines Agency)

deciphera pharmaceuticals (netherlands) b.v. - ripretinib - gastrointestinal stromal tumors - antineoplastic agents - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (gist) who have received prior treatment with three or more kinase inhibitors, including imatinib.

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

deciphera pharmaceuticals, llc - ripretinib (unii: 9xw757o13d) (ripretinib - unii:9xw757o13d) - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (gist) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , qinlock can cause fetal harm when administered to a pregnant woman. there are no available data on the use of qinlock in pregnant women to inform a drug-associated risk. administration of ripretinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations primarily associated with the cardiovascular and skeletal systems, anatomic variations, reduced fetal body weight, and increased post-implantation loss at maternal exposures that were approximately equal to the human exposure at the recommended dose of 150 mg (see data ). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects an

Canada - English - Health Canada

deciphera pharmaceuticals. llc - ripretinib - tablet - 50mg - ripretinib 50mg - antineoplastic agents

Israel - English - Ministry of Health

medison pharma ltd - ripretinib - tablets - ripretinib 50 mg - ripretinib - qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (gist) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Malta - English - Medicines Authority

baxter holding b.v. kobaltweg 49, 3542ce utrecht, netherlands - calcium chloride, dihydrate, phenylalanine, potassium chloride, histidine, arginine, aspartic acid, olive oil, threonine, tryptophan, tyrosine, valine, glucose monohydrate, glutamic acid, glycine, methionine, isoleucine, lysine, magnesium chloride, hexahydrate, serine, proline, sodium acetate, trihydrate, sodium glycerophosphate, soybean oil - emulsion for infusion - tryptophan tyrosine valine glucose monohydrate glutamic acid glycine methionine isoleucine lysine magnesium chloride hexahydrate serine proline sodium acetate trihydrate sodium glycerophosphate soybean oil calcium chloride dihydrate phenylalanine potassium chloride histidine arginine aspartic acid olive oil alanine threonine - blood substitutes and perfusion solutions

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

aft pharmaceuticals pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - analgesia (adults and children over 12 years of age) ? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain (excluding intermittent top up injections) ? field block (minor nerve block and infiltration) ? continuous peripheral nerve block infusion or intermittent injections for post ? operative pain management ? continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0 - 12 years) ? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine-aft for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

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

aft pharmaceuticals pty ltd - ropivacaine hydrochloride, quantity: 2 mg/ml - injection, intravenous infusion - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - analgesia (adults and children over 12 years of age) ? continuous epidural infusion or intermittent bolus epidural administration for analgesia in postoperative pain or labour pain (excluding intermittent top up injections) ? field block (minor nerve block and infiltration) ? continuous peripheral nerve block infusion or intermittent injections for post ? operative pain management ? continuous wound infusion for postoperative pain management (adults only) analgesia (children aged 0 - 12 years) ? continuous epidural infusion in infants (> 30 days and over 2500 g weight) and children up to and including 12 years,for peri- and postoperative pain management. there are no safety or efficacy data to support the use of ropivacaine-aft for analgesia for longer than 72 hours. (data for peripheral nerve block administered as a continuous peripheral infusion or intermittent injections and for continuous wound infusion support the use for up to 48 hours only).

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

bio-excel australia pty ltd - 40601 - peripheral vascular infusion/aspiration catheter - goback crossing catheter is intended to be used in conjunction with a steerable guide wire to access discrete regions of the peripheral vasculature. it may be used to facilitate placement and exchange of guidewires.

Malta - English - Medicines Authority

centrient pharmaceuticals netherlands b.v (dsm sinochem) alexander fleminglaan 1, 2613 ax delft, netherlands - caspofungin acetate - powder for concentrate for solution for infusion - caspofungin acetate 50 mg - antimycotics for systemic use

Malta - English - Medicines Authority

centrient pharmaceuticals netherlands b.v (dsm sinochem) alexander fleminglaan 1, 2613 ax delft, netherlands - caspofungin acetate - powder for concentrate for solution for infusion - caspofungin acetate 70 mg - antimycotics for systemic use