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Patient Information (download PDF, 250KB). Canadian regulations limit the scope of information we are permitted to give on prescription drugs via the Internet or other means. TRAZIMERA (trastuzumab-qyyp) for injection is a sterile, white, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration. Each multiple-dose vial of TRAZIMERA delivers 420 mg trastuzumab-qyyp, 7.9 mg L-histidine, 9.5 mg L-histidine HCl monohydrate, 1.7 mg polysorbate 20, and 386 mg sucrose. and/or address of a manufacturer or an ASMF holder or supplier of the AS, starting material, reagent or intermediate used in the manufacture of the AS or manufacturer of a novel excipient B.II.e.3.a - Change in test procedure for the immediate packaging of the finished product - Minor changes to an approved test procedure 11/10/2019 n/a Trazimera 150 mg powder for concentrate for solution for infusion.

the rigorous requirements of development, manufacturing and licensing, Feb 11, 2020 The pricing of medicines by pharmaceutical manufacturers and the cost of healthcare, which includes Trazimera (trastuzumab-qyyp)(d). TRAZIMERA, in combination with the chemotherapy drug paclitaxel, is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer TRAZIMERA alone is approved for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease Developed and marketed by Pfizer Summary: Trazimera is a biosimilar version of trastuzumab (reference product, Herceptin, Roche, Inc.) developed by Pfizer. TRAZIMERA for Injection (trastuzumab-qyyp) This product information is intended only for residents of the United States. for Consumers: Pfizer Oncology Together Find information about TRAZIMERA™ (trastuzumab-qyyp), an FDA-approved biosimilar of HERCEPTIN® (trastuzumab), on the HCP site. † WAC is a manufacturer's § The Injectables Co-Pay Program for TRAZIMERA provides assistance for eligible, commercially insured patients prescribed TRAZIMERA for co-pays or coinsurance incurred for TRAZIMERA up to $25,000 per calendar year.

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has approved TRAZIMERA™,1 a biosimilar to Herceptin®* (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 This approval follows the recommendation from the Committee for Medicinal Trazimera 150 mg powder for concentrate for solution for infusion. One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by chromatography including specific viral inactivation and removal procedures.

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Pharmacology, adverse reactions, warnings and side effects. Consumer Medicine Information (CMI) about Trazimera (Trastuzumab) intended for persons living in Australia. Injectables for TRAZIMERA provides eligible commercially insured patients with assistance of up to $25,000 per calendar year. Eligible enrolled patients may pay as little as $0 for each TRAZIMERA treatment.

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Manufacturer: Pfizer. Distributor: Zuellig Pharma. Contents: trastuzumab. MIMS Class: Targeted Cancer Therapy. Aug 9, 2019 Trazimera. Pfizer. Mar 2019.
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Jun 2019. Results 27 - 51 of 54 Fosun Pharma's Henlius, a leading biotech company in China OncologyPfizer RegulationRocheSwitzerlandTrazimeraUS FDAUSA.

Herceptin1-3. 2020-12-18 TRAZIMERA: TRASTUZUMAB-QYYP: 420MG: INJECTABLE;INJECTION: Prescription: None No: No 0069-0305 - Trazimera . 0069-0305-01 - 1 KIT in 1 KIT * 20 mL in 1 VIAL, MULTI-DOSE (0069-0306-01) * 20 mL in 1 VIAL (0069-0307-01) The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler.
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Originally designated PF-05280014 , a biologic license application for approval via the 351 (k) biosimilar pathway was initially submitted to the Food and Drug Administration (FDA) in the third quarter of 2017. TRAZIMERA for Injection (trastuzumab-qyyp) This product information is intended only for residents of the United States. for Consumers: Pfizer Oncology Together™ provides financial assistance resources to help patients access their prescribed Oncology medicines. for Health Care Professionals: 2019-09-04 Pfizer's trastuzumab biosimilar to Herceptin, Trazimera, launched Wednesday in the United States. Trazimera is available for the treatment of human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. 2020-01-24 At Pfizer Oncology Together, we treat your individual needs as a priority.

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TRAZIMERA (trastuzumab-qyyp) for injection 420 mg/vial is supplied in a multiple-dose vial as a sterile, white lyophilized powder. Each carton contains one multiple-dose vial of TRAZIMERA and one vial (20 mL) of Bacteriostatic Water for Injection (BWFI) containing 1.1% benzyl alcohol as a preservative. Trastuzumab helps to mediate antibody-dependent cellular cytotoxicity (ADCC) preferentially against cells that overexpress HER2. Route: IV. Extravasation: neutral. For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450 pharmaceutical manufacturers that are not affiliated with CVS Caremark. 1 SPECIALTY GUIDELINE MANAGEMENT HERCEPTIN (trastuzumab) OGIVRI (trastuzumab-dkst) KANJINTI (trastuzumab-anns) TRAZIMERA (trastuzumab-qyyp) POLICY I. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered a covered Learn about TRAZIMERA™ (trastuzumab-qyyp), an FDA-approved biosimilar of HERCEPTIN® (trastuzumab), on the official patient website. Covid Banner Pfizer recognizes the public concern in relation to COVID-19, which continues to evolve.

Lämplig aseptisk teknik ska användas. Trazimera, PULVER TIL KONSENTRAT TIL INFUSJONSVÆSKE, oppløsning: Styrke Pakning Varenr. SPC 1 Refusjon 2 Byttegruppe Pris (kr) 3 R.gr. 4; 150 mg: 1 stk. (hettegl 2020-12-18 · Brand name: Trazimera Chemical name: Trastuzumab-qyyp Class: HER2 (human epidermal receptor 2) inhibitor targeted therapy. Herceptin, Herzuma, Kanjinti, Margenza, Nerlynx, Ogivri, Ontruzant, Perjeta, Phesgo, and Tykerb are other HER2 inhibitors. Uses: Trazimera typically is used to: treat metastatic, HER2-positive breast cancer At Pfizer Oncology Together, we treat your individual needs as a priority.