Καναδάς - Αγγλικά - Health Canada

sanofi-aventis canada inc - alirocumab - solution - 75mg - alirocumab 75mg - proprotein convertase subtilisin kexin type 9 (pcsk9) inhibitors

Καναδάς - Αγγλικά - Health Canada

sanofi-aventis canada inc - alirocumab - solution - 150mg - alirocumab 150mg - proprotein convertase subtilisin kexin type 9 (pcsk9) inhibitors

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

bristol-myers squibb australia pty ltd - daclatasvir dihydrochloride -

Καναδάς - Αγγλικά - Health Canada

loxo oncology inc - selpercatinib - capsule - 40mg - selpercatinib 40mg - antineoplastic agents

Καναδάς - Αγγλικά - Health Canada

loxo oncology inc - selpercatinib - capsule - 80mg - selpercatinib 80mg - antineoplastic agents

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - measles virus strain schwartz attenuated chick embryo fibroblasts live antigen (unii: yrf2uzg52m) (measles virus strain schwartz attenuated chick embryo fibroblasts live antigen - unii:yrf2uzg52m), mumps virus strain rit-4385 attenuated chick embryo fibroblasts live antigen (unii: 566fj5l8r4) (mumps virus strain rit-4385 attenuated chick embryo fibroblasts live antigen - unii:566fj5l8r4), rubella virus strain wistar ra 27/3 live antigen (unii: 52202h034z) (rubella virus strain wistar ra 27/3 live antigen - unii:52202h034z) - priorix is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older. do not administer priorix to individuals with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of any measles, mumps, and rubella virus-containing vaccine [see description (11)] . due to the risk of disseminated vaccine virus infection, do not administer priorix to individuals with severe humoral or cellular (primary or acquired) immunodeficiency. do not administer priorix to individuals who are pregnant. pregnancy should be avoided for 1 month after vaccination [see use in specific populations (8.1)] . risk summary priorix contains live attenuated measles, mumps, and rubella viruses. the vaccine is contraindicated for use in pregnant women because infection during pregnancy with the wild-type viruses is associated with maternal and fetal adverse outcomes. pregnancy should be avoided for 1 month after vaccination [see contraindications (4.3), patient counseling information (17)]. reports have indicated that contracting wild-type measles during pregnancy enhances fetal risk, including increased rates of spontaneous abortion, stillbirth, premature delivery and congenital defects.2,3 wild-type mumps virus infection during the first trimester of pregnancy may increase the rate of spontaneous abortion. pregnant women infected with wild-type rubella virus are at increased risk for miscarriage or stillbirth, and their infants are at risk for congenital rubella syndrome.1 available data on inadvertent administration of priorix to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. there are no animal studies with priorix to inform use during pregnancy. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. 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. risk summary it is not known whether the vaccine components of priorix are excreted in human milk. data are not available to assess the effects of priorix on the breastfed infant or on milk production/excretion. studies have shown that lactating postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast‑fed infants.4,5 in the breast-fed infants with serological evidence of rubella virus vaccine strain antibodies, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella.6,7 the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for priorix and any potential adverse effects on the breastfed child from priorix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness of priorix in infants younger than 12 months have not been established. clinical studies of priorix did not include participants 65 years of age and older to determine whether they respond differently from younger participants.

Ισραήλ - Αγγλικά - Ministry of Health

eli lilly israel ltd, israel - selpercatinib - capsules - selpercatinib 40 mg - selpercatinib - • metastatic ret fusion-positive non-small cell lung cancerretevmo™ is indicated for the treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer (nsclc).• ret-mutant medullary thyroid cancerretevmo 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.• ret fusion-positive thyroid cancerretevmo is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Ισραήλ - Αγγλικά - Ministry of Health

eli lilly israel ltd, israel - selpercatinib - capsules - selpercatinib 80 mg - selpercatinib - • metastatic ret fusion-positive non-small cell lung cancerretevmo™ is indicated for the treatment of adult patients with metastatic ret fusion-positive non-small cell lung cancer (nsclc).• ret-mutant medullary thyroid cancerretevmo 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.• ret fusion-positive thyroid cancerretevmo is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

protein sciences corporation - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen (unii: 69h0yj871t) (influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen - unii:69h0yj871t) - influenza a virus a/michigan/45/2015 (h1n1) recombinant hemagglutinin antigen 45 ug in 0.5 ml

Ηνωμένες Πολιτείες - Αγγλικά - NLM (National Library of Medicine)

bavarian nordic a/s - vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen (unii: tu8j357395) (vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen - unii:tu8j357395) - jynneos is a vaccine indicated for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the us 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. available human data on jynneos administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. the effect of jynneos on embryo-fetal and post-natal development was evaluated in four developmental toxicity studies conducted in female rats and rabbits. in two studies, rats were administered a single human dose of jynneos (0.5 ml) once prior to mating and on one or two occasions during gestation. in the third study, rats were administered a single human dose of jynneos (0.5 ml) on two occasions during gestation. in the fourth study, rabbits were ad