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

wyeth pharmaceuticals llc, a subsidiary of pfizer inc. - gemtuzumab ozogamicin (unii: 8gzg754x6m) (gemtuzumab ozogamicin - unii:8gzg754x6m) - gemtuzumab ozogamicin 5 mg in 5 ml - mylotarg is indicated for the treatment of newly-diagnosed cd33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older. mylotarg is indicated for the treatment of relapsed or refractory cd33-positive acute myeloid leukemia in adults and pediatric patients 2 years and older. mylotarg is contraindicated in patients with a history of hypersensitivity to the active substance in mylotarg or any of its components or to any of the excipients. reactions have included anaphylaxis [see warnings and precautions (5.2), adverse reactions (6)] . risk summary based on its mechanism of action and findings from animal studies [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] , mylotarg can cause embryo-fetal harm when administered to a pregnant woman. there are no available data on mylotarg use in pregnant women to evaluate for a drug-associated risk. in animal reproduction studies, gemtuzumab ozogamicin caused embryo-fetal toxicity, including structural abnormalities and alteration

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - pertuzumab - concentrate for solution for infusion - pertuzumab 420 mg / 14 ml - pertuzumab - pertuzumab - early breast cancer 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. • the adjuvant treatment of patients with her2-positive early breast cancer (node positive) at high risk of recurrence .metastatic breast cancerperjeta 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.

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

roche products pty ltd - pertuzumab, quantity: 420 mg - injection, intravenous infusion - excipient ingredients: histidine; sucrose; glacial acetic acid; water for injections; polysorbate 20 - early breast cancer perjeta is indicated in combination with trastuzumab and chemotherapy for:,- the neoadjuvant treatment of patients with her2-positive inflammatory or locally advanced, or early stage (either > 2 cm in diameter or node positive) breast cancer as part of a complete treatment regimen for early breast cancer,-the adjuvant treatment of patients with her2-positive early breast cancer at high risk of recurrence.,metastatic breast cancer,perjeta is indicated in combination with trastuzumab and docetaxel for patients with metastatic her2-positive breast cancer who have not received prior anti-her2 therapy or chemotherapy for their metastatic disease.

United States - English - 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

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

pfizer australia pty ltd - gemtuzumab ozogamicin, quantity: 5 mg - injection, powder for - excipient ingredients: sucrose; dextran 40; sodium chloride; monobasic sodium phosphate monohydrate; dibasic sodium phosphate - mylotarg is indicated for combination therapy with standard anthracycline and cytarabine (arac) for the treatment of patients age 15 years and above with previously untreated, de novo cd33-positive acute myeloid leukaemia (aml), except acute promyelocytic leukaemia (apl) (see section 4.4 special warnings and precautions for use, and section 5.1 pharmacodynamic properties).

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

f. hoffmann-la roche ltd - pertuzumab - pertuzumab....600 mg / trastuzumab....600 mg

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

f. hoffmann-la roche ltd - pertuzumab - pertuzumab....1200 mg / trastuzumab....600 mg

Israel - English - Ministry of Health

pfizer pharmaceuticals israel ltd - gemtuzumab ozogamicin - powder for concentrate for solution for infusion - gemtuzumab ozogamicin 5 mg/vial - gemtuzumab - mylotarg is indicated for the treatment of newly-diagnosed cd33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older.mylotarg is indicated for the treatment of relapsed or refractory cd33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older…….

Kenya - English - Pharmacy and Poisons Board

f. hoffman-la roche ltd grenzacherstrasse 124, ch-4070, basel, switzerland - pertuzumab and trastuzumab - solution for injection - each ml of solution contains 80 mg of pertuzumab… - pertuzumab and trastuzumab

European Union - English - EMA (European Medicines Agency)

roche registration gmbh - pertuzumab, trastuzumab - breast neoplasms - antineoplastic agents - early breast cancer (ebc)phesgo is indicated for use in combination with chemotherapy in:the neoadjuvant treatment of adult patients with her2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrencethe adjuvant treatment of adult patients with her2-positive early breast cancer at high risk of recurrencemetastatic breast cancer (mbc)phesgo is indicated for use in combination with docetaxel in adult patients with her2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-her2 therapy or chemotherapy for their metastatic disease.