USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - pertuzumab (unii: k16aiq8ctm) (pertuzumab - unii:k16aiq8ctm), trastuzumab (unii: p188anx8ck) (trastuzumab - unii:p188anx8ck), hyaluronidase (human recombinant) (unii: 743quy4vd8) (hyaluronidase (human recombinant) - unii:743quy4vd8) - phesgo is indicated for use in combination with chemotherapy for - the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer [see dosage and administration (2.2) and clinical studies (14.2)] . - the adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrence [see dosage and administration (2.2) and clinical studies (14.2)] . select patients for therapy based on an fda-approved companion diagnostic test [see dosage and administration (2.1)]. phesgo is indicated for use in combination with docetaxel for the treatment of adult patients with her2-positive metastatic breast cancer who have not received prior anti-her2 therapy or chemotherapy for metastatic disease [see dosage and administration (2.2) and clinical studies (14.1)] . select patients for therapy based on an fda-approved compa

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - enfuvirtide (unii: 19owo1t3ze) (enfuvirtide - unii:19owo1t3ze) - enfuvirtide 90 mg in 1 ml - fuzeon® in combination with other antiretroviral agents is indicated for the treatment of hiv-1 infection in treatment-experienced patients with evidence of hiv-1 replication despite ongoing antiretroviral therapy. fuzeon is contraindicated in patients with known hypersensitivity to fuzeon or any of its components [see warnings and precautions (5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to antiretroviral medicines during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr are not sufficient to adequately assess the risk of birth defects or fetal outcomes. limited number of reports on the use of enfuvirtide during pregnancy has been submitted to the apr and the number of exposures to enfuvirtide is insufficient to make a risk assessment compared to a reference population. all pregna

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - bevacizumab (unii: 2s9zzm9q9v) (bevacizumab - unii:2s9zzm9q9v) - bevacizumab 100 mg in 4 ml - avastin, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mcrc). avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mcrc who have progressed on a first-line bevacizumab product-containing regimen. limitations of use : avastin is not indicated for adjuvant treatment of colon cancer [see clinical studies (14.2)]. avastin, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (nsclc). avastin is indicated for the treatment of recurrent glioblastoma (gbm) in adults. avastin, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mrcc). avastin, in combination with paclitaxel and cisplatin

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - pirfenidone (unii: d7nld2jx7u) (pirfenidone - unii:d7nld2jx7u) - pirfenidone 267 mg - esbriet is indicated for the treatment of idiopathic pulmonary fibrosis (ipf). none. risk summary the data with esbriet use in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage. in animal reproduction studies, pirfenidone was not teratogenic in rats and rabbits at oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (mrdd) in adults [see data] . 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 animal reproductive studies were conducted in rats and rabbits. in a combined fertility and embryofetal development study, female rats received pirfenidone at oral doses of 0, 50, 150, 450, and 1000 mg/kg/day from 2 weeks prior to mating, during the mating phase, and throughout the periods of early embryonic development from gestation days (gd) 0 to 5 and organogenesis from gd 6 to 17. in an embry

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - cobimetinib fumarate (unii: 6exi96h8sv) (cobimetinib - unii:er29l26n1x) - cobimetinib 20 mg - cotellic® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600e or v600k mutation, in combination with vemurafenib. cotellic®, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms. none. risk summary based on findings from animal reproduction studies and its mechanism of action, cotellic can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. there are no available data on the use of cotellic during pregnancy. in animal reproduction studies, oral administration of cobimetinib in pregnant rats during organogenesis was teratogenic and embryotoxic at exposures (auc) that were 0.9 to 1.4-times those observed in humans at the recommended human dose of 60 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 and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - pertuzumab (unii: k16aiq8ctm) (pertuzumab - unii:k16aiq8ctm) - pertuzumab 30 mg in 1 ml - perjeta is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with her2-positive metastatic breast cancer who have not received prior anti-her2 therapy or chemotherapy for metastatic disease [see dosage and administration (2.2) and clinical studies (14.1)] . perjeta is indicated for use in combination with trastuzumab and chemotherapy for - the neoadjuvant treatment of patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer [see dosage and administration (2.2) and clinical studies (14.2)] . - the adjuvant treatment of patients with her2-positive early breast cancer at high risk of recurrence [see dosage and administration (2.2) and clinical studies (14.3)] . perjeta is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients. pregnancy pharmacovigilance program there is a pre

USA - engelsk - NLM (National Library of Medicine)

genentech, inc. - trastuzumab emtansine (unii: se2kh7t06f) (ado-trastuzumab emtansine - unii:se2kh7t06f) - ado-trastuzumab emtansine 20 mg in 1 ml - kadcyla® , as a single agent, is indicated for the treatment of patients with her2-positive, metastatic 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. select patients for therapy based on an fda-approved companion diagnostic for kadcyla [see dosage and administration (2.1) ]. 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. select patients for therapy based on an fda-approved companion diagnostic for kadcyla [see dosage and administration (2.1) ]. none. pregnancy pharmacovigilance program there is a pregnancy pharmacovigilance program for kadcyla. if kadcyla is administered during pregnancy, or if a patient becomes pregnant while r

Singapore - engelsk - HSA (Health Sciences Authority)

roche singapore pte. ltd. - trastuzumab - injection, powder, for solution - 440 mg/vial - trastuzumab 440 mg/vial

Grækenland - græsk - Εθνικός Οργανισμός Φαρμάκων

ΙΦΕΤ ΑΕ - bevacizumab - ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ - 100mg/4ml - ineof01704 - bevacizumab - 0.000000

Grækenland - græsk - Εθνικός Οργανισμός Φαρμάκων

ΙΦΕΤ ΑΕ - bevacizumab - ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ - 400mg/16 ml - ineof01704 - bevacizumab - 0.000000