European Union - English - EMA (European Medicines Agency)

blueprint medicines (netherlands) b.v. - avapritinib - gastrointestinal stromal tumors - other antineoplastic agents, protein kinase inhibitors - ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (gist) harbouring the platelet-derived growth factor receptor alpha (pdgfra) d842v mutation.

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

stryker australia pty ltd - 40885 - radionuclide system, therapeutic, stereotactic radiosurgery, application program software - intended for use during shoulder prosthesis surgery to aid surgeons by visualizing stereoscopic three-dimensional images of the patient?s bony anatomy and intraoperatively aid by guiding of the pin during placement through real-time feedback.

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

blueprint medicines corporation - avapritinib (unii: 513p80b4yj) (avapritinib - unii:513p80b4yj) - ayvakit® is indicated for the treatment of adults with unresectable or metastatic gist harboring a platelet-derived growth factor receptor alpha (pdgfra) exon 18 mutation, including pdgfra d842v mutations [see dosage and administration (2.2)] . ayvakit is indicated for the treatment of adult patients with advanced systemic mastocytosis (advsm). advsm includes patients with aggressive systemic mastocytosis (asm), systemic mastocytosis with an associated hematological neoplasm (sm-ahn), and mast cell leukemia (mcl). limitations of use : ayvakit is not recommended for the treatment of patients with advsm with platelet counts of less than 50 × 109 /l [see warnings and precautions (5.1)] . ayvakit is indicated for the treatment of adult patients with indolent systemic mastocytosis (ism). limitations of use : ayvakit is not recommended for the treatment of patients with ism with platelet counts of less than 50 × 109 /l [see warnings and precautions (5.1)] . none. risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , ayvakit can cause fetal harm when administered to a pregnant woman. there are no available data on ayvakit use in pregnant women. oral administration of avapritinib to pregnant rats during the period of organogenesis was teratogenic and embryotoxic at exposure levels approximately 31.4, 6.3 and 2.7 times the human exposure based on auc at the 25 mg, 200 mg and 300 mg dose, respectively (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 and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in a reproductive toxicity study, administration of avapritinib to rats during the period of organogenesis resulted in decreased fetal body weights, post-implantation loss, and increases in visceral (hydrocephaly, septal defect, and stenosis of the pulmonary trunk) and skeletal (sternum) malformations at doses greater than or equal to 10 mg/kg/day (approximately 31.4, 6.3 and 2.7 times the human exposure based on auc at the 25 mg, 200 mg and 300 mg dose, respectively). risk summary there are no data on the presence of avapritinib or its metabolites in human milk or the effects of avapritinib on the breastfed child or milk production. because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with ayvakit and for 2 weeks following the final dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating ayvakit [see use in specific populations (8.1)] . contraception ayvakit can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)]. females advise females of reproductive potential to use effective contraception during treatment with ayvakit and for 6 weeks after the final dose. males advise males with female partners of reproductive potential to use effective contraception during treatment with ayvakit and for 6 weeks after the final dose. infertility females based on findings from animal studies, ayvakit may impair female fertility. these findings were not reversible within a two month recovery period [see nonclinical toxicology (13.1)]. males based on findings from animal studies, ayvakit may impair male fertility. these findings were not reversible within a two month recovery period [see nonclinical toxicology (13.1)] . the safety and effectiveness of ayvakit in pediatric patients have not been established. of the 204 patients with unresectable or metastatic gist who received ayvakit in navigator, 40% were 65 years or older, while 6% were 75 years and older. of the 131 patients with advsm who received ayvakit in explorer and in pathfinder, 62% were 65 years or older, while 21% were 75 years and older. of the 141 patients with ism who received ayvakit in pioneer, 6% were 65 years or older, while <1% were 75 years and older. no overall differences in safety or efficacy were observed between these patients and younger adult patients. no dose adjustment is recommended for patients with mild or moderate renal impairment [creatinine clearance (clcr) 30 to 89 ml/min estimated by cockcroft-gault]. the recommended dose of ayvakit has not been established for patients with severe renal impairment (clcr 15 to 29 ml/min) or end-stage renal disease (clcr <15 ml/min) [see clinical pharmacology (12.3)] . no dose adjustment is recommended for patients with mild [total bilirubin ≤ upper limit of normal (uln) and aspartate aminotransferase (ast) > uln or total bilirubin > 1 to 1.5 times uln and any ast], or moderate [total bilirubin >1.5 to 3 times uln and any ast] hepatic impairment. unbound auc0-inf was 61% higher in subjects with severe hepatic impairment (child-pugh class c) as compared to matched healthy subjects with normal hepatic function. a lower starting dose is recommended in patients with severe hepatic impairment [see dosage and administration (2.7)] .

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

blueprint medicines corporation - pralsetinib (unii: 1wpe73o1wv) (pralsetinib - unii:1wpe73o1wv) - gavreto is indicated for the treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer (nsclc) as detected by an fda approved test. this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret -mutant medullary thyroid cancer (mtc) who require systemic therapy. this indication is approved under accelerated approval based on overall response rate and duration of response [see clinical studies (14.2)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older wit

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

stryker australia pty ltd - 41018 - cad/cam unit, orthopaedic - blueprint 3d planning software is an application that helps a surgeon plan their patients' shoulder prosthesis surgery pre-operatively. it generates the information required to produce a guide that is specific to each patient, and enables the insertion of a pin following the reaming axis aimed at preparing the glenoid fossa surface.

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

genome investigation pty ltd - ct910 - interpretive software ivds - the agendia-secured data analysis pipeline tool (adapt) takes gene expression profiling data (.fastq file) from the mammaprint breast cancer recurrence risk and blueprint molecular subtyping kit (see artg 356739) to generate both a breast cancer distant recurrence risk and a molecular subtype (luminal, basal or her2) of the formalin-fixed, paraffin-embedded (ffpe) breast cancer tissue.

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

genome investigation pty ltd - ct929 - acquired genetic alteration ivds - the mammaprint breast cancer recurrence risk and blueprint molecular subtyping ngs kit is an in vitro diagnostic which generates data (.fastq file) from gene expression profiling of breast cancer tissue performed by next generation sequencing. this data is used to generate both a breast cancer distant recurrence risk and a molecular subtype (luminal, basal or her2) via a second step using the agendia-secured data analysis pipeline tool (adapt) (see artg 356740). the assay measures the gene expression profile on a next generation sequencer using rna extracted from formalin-fixed, paraffin-embedded (ffpe) breast cancer tissue.

Malta - English - Medicines Authority

leo pharma a/s industriparken 55, 2750-dk ballerup, denmark - calcipotriol - cream - calcipotriol 50 µg/g - antipsoriatics

Malta - English - Medicines Authority

leo pharma a/s - fusidic acid - cream - fusidic acid - antibiotics and chemotherapeutics for dermatological use

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

leo pharma - calcipotriol monohydrate - cutaneous solution - 50microgram/1ml