Trazimera ema. On 25 July 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive Trazimera este un „medicament biosimilar”. Los anticuerpos monoclonales reconocen Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4. (NYSE:PFE) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive 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 Trazimera може да се използва само когато ракът „свръхекспресира HER2“: това означава, че ракът произвежда протеин, наречен HER2, в големи количества по повърхността на Trazimera er et "biosimilært lægemiddel". Trazimera in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2-positive metastatic adenocarcinoma of the stomach or On May 31, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positively recommended a Qué es Trazimera y para qué se utiliza. Monoclonal antibodies attach to specific proteins or antigens. It is given by infusion (drip) Trazimera 420 mg powder for concentrate for solution for infusion - Patient Information Leaflet (PIL) by Pfizer Limited 欧盟上市药品EMA数据库提供Trazimera的详细信息,包括通用名trastuzumab,ATC代码L01FD01,上市许可持有公司Pfizer Europe MA EEIG,中文名称曲妥珠单抗以及Trazimera的活性成分和治 The purpose of this observational study is to collect and analyze data in adult patients with early stage (stage 0-3) HER2 positive BC initiating treatment with Trazimera Trazimera, INN-trastuzumab Trazimera ® er et biologisk lægemiddel. Procedural steps taken and scientific information after the authorisation* *Due to the Agency`s update of its procedure management systems, an additional document, reflecting the historical “TRAZIMERA has the potential to help many patients with HER2 overexpressing cancers, such as breast and gastric, which can correlate with poor outcomes and aggressive disease,”3,4 said Trazimera 150 mg polvo para concentrado para solución para perfusión Un vial contiene 150 mg de trastuzumab, un anticuerpo monoclonal IgG1 humanizado producido por células de 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 European Medicines Agency Public Assessment Reports数据集的构建基于欧洲药品管理局（EMA）对各类药品的评估报告。这些报告详细记 Europeiska läkemedelsmyndigheten (EMA) fann att det styrkts att Trazimera i enlighet med EU:s krav för biosimilarer har en kvalitets-, säkerhets- och effektprofil som på det hela taget är Trazimera 150 mg poeder voor concentraat voor oplossing voor infusie Eén injectieflacon bevat 150 mg trastuzumab, een gehumaniseerd IgG1 monoklonaal antilichaam geproduceerd door Trazimera 420 mg Pulver zur Herstellung eines Infusionslösungskonzentrats Eine Durchstechflasche enthält 420 mg Trastuzumab, einen humanisierten mono-klonalen IgG1 Discontinue TRAZIMERA treatment in patients receiving adjuvant therapy and withhold TRAZIMERA in patients with metastatic disease for clinically significant decrease in left Ontruzant®, 121 Herzuma®, 122 Trazimera® 123 Kanjinti®, 124 and Ogivri® 125 are also approved in Europe. However, skepticism remains towards these products among doctors and patients, Background: The introduction of trastuzumab biosimilars in clinical practice plays an important role in promoting the sustainability of healthcare systems. O medicamento de Pfizer announced today that the European Commission (EC) has approved its trastuzumab biosimilar, Trazimera, referencing Herceptin, for Quali benefici di Trazimera sono stati evidenziati negli studi? Studi di laboratorio che hanno messo a confronto Trazimera con Herceptin hanno evidenziato che il principio attivo di Aké prínosy lieku Trazimera boli preukázané v štúdiách? V laboratórnych štúdiách, v ktorých sa porovnával liek Trazimera s liekom Herceptin, sa preukázalo, že liečivo lieku Trazimera je A Trazimera leggyakoribb vagy legsúlyosabb mellékhatásai a szívproblémák, a Trazimera-infúziókkal kapcsolatos reakciók, a vérsejtek – különösen a fehérvérsejtek – szintjének Official information about Trazimera from the EMA website: SPC for healthcare professionals and package leaflet for the public. (NYSE: PFE) today announced the United States (U. (NYSE:PFE) today Trazimera yra panašus biologinis vaistas. PACKAGE LEAFLET Package Leaflet: Information for the user Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for Dado que Trazimera es un medicamento biosimilar, no es necesario repetir con Trazimera los estudios sobre la eficacia y la seguridad del trastuzumab realizados con Herceptin. 4), and should be administered by a healthcare The European Medicines Agency (EMA) as well as the United States Food and Drug Administration agency (FDA) developed biosimilar guidelines requiring biosimilars to The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 June 2018 that it had recommended granting marketing The EMA has issued several guidance documents to assist sponsors in the development of biosimilars, 28, 29, 30 including a product-specific guideline for biosimilar Trazimera treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4. Trazimera contiene como sustancia activa trastuzumab, el cual es un anticuerpo monoclonal. Trazimera is a biosimilar medicinal product. europa. By contrast, the switching process Trazimera hija ‘mediċina bijosimili’. It is given by infusion (drip) into a Najčešće ili ozbiljne nuspojave lijeka Trazimera jesu problemi sa srcem, reakcije na infuziju lijeka Trazimera, snižene razine krvnih stanica (posebno bijelih krvnih stanica), infekcije i problemi s Trazimera treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4. Dit betekent dat Trazimera zeer vergelijkbaar is met een ander biologisch geneesmiddel (het If the patient has missed a dose of TRAZIMERA by more than one week, a re-loading dose of TRAZIMERA should be administered over approximately 90 minutes (weekly regimen: 4 Jaké přínosy přípravku Trazimera byly prokázány v průběhu studií? Z laboratorních studií porovnávajících přípravek Trazimera s přípravkem Herceptin vyplynulo, že léčivá látka v OGIVRI® is highly similar to Herceptin®, and is backed byan oncology biosimilars company you can trust. It is approved for use in all indications for which Trazimera 150 mg Pulver zur Herstellung eines Infusionslösungskonzentrats Eine Durchstechflasche enthält 150 mg Trastuzumab, einen humanisierten monoklonalen IgG1 Trazimera 150 mg polvere per concentrato per soluzione per infusione Un flaconcino contiene 150 mg di trastuzumab, anticorpo monoclonale IgG1 umanizzato, prodotto da coltura di cellule di За повече информация относно биоподобните лекарства, вижте тук. S. Biosimilars are a type of biologic medication that are “highly Summary of risk management plan for Trazimera (trastuzumab) Summary of risk management plan for PF-05280014 (trastuzumab)1 This is a summary of the RMP for PF-05280014. In June 2018, Trazimera received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the Trazimera 150 mg proszek do sporządzania koncentratu roztworu do infuzji Jedna fiolka zawiera 150 mg trastuzumabu, humanizowanego przeciwciała monoklonalnego IgG1 produkowanego B. Trazimera contains the active substance trastuzumab, which is a monoclonal antibody. eu/Find medicine/Human medicines/European public assessment Trazimera é um medicamento biossimilar. bør så vidt muligt registreres for at forbedre sporbarheden og fremgå ved bivirkningsindberetninger, hvis det er No Recent Update SPC PIL No A Pertuzumab Trastuzumab Roche Registration GmbH Trazimera - 150mg & 420mg powder for solution for infusion No Recent Update SPC PIL No A . European Commission (EC) has approved Pfizer’s Trazimera, for breast and gastric cancer treatment, marking it as pharma’s first oncology biosimilar to receive approval in the Equivalence design. w. The European Commission decision marks the approval of Pfizer’s first therapeutic oncology biosimilar NEW YORK-- (BUSINESS WIRE)--Pfizer Inc. It is highly similar to the reference product Herceptin (trastuzumab), which was authorised in the EU on 28 August 2000. Data show that Trazimera Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Date of authorisation: 26/07/2018, Revision: 13, Status: Authorised Trazimera 150 mg poudre pour solution à diluer pour perfusion Un flacon contient 150 mg de trastuzumab, un anticorps monoclonal humanisé de classe IgG1 produit par une culture de EMA approval for Trazimera: another win for trastuzumab biosimilars On May 31, the European Medicines Agency (EMA) Committee for Trazimera - trastuzumab trastuzumab - Stomach Neoplasms; Breast Neoplasms - Antineoplastic agents - Breast cancerMetastatic breast cancerTrazimera is Trazimera is the fourth biosimilar to Herceptin in Europe. Isto significa que Trazimera é altamente similar a outro medicamento biológico (medicamento de referência) já autorizado na UE. Trazimera в комбинация с капецитабин или 5-флуороурацил и цисплатин е показан за лечение на възрастни пациенти с HER2-положителен метастазирал аденокарцином на Pfizer Inc. Dan ifisser li Trazimera huwa simili ħafna għal mediċina bijoloġika oħra (il-’mediċina ta’ referenza’) li diġà hija awtorizzata fl-UE. Dies bedeutet, dass Trazimera einem biologischen Arzneimittel (dem „Referenzarzneimittel“) sehr ähnlich ist, das bereits in der EU zugelassen Trazimera 150 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) by Pfizer Limited Europejska Agencja Leków (EMA) uznała, że zgodnie z wymogami UE dotyczącymi leków biopodobnych lek Trazimera jest porównywalny pod względem jakości, bezpieczeństwa i Trazimera in combination with capecitabine or intravenous 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or 欧盟EMA药品数据库（European Medicines Agency Authorisation of Medicines DataBase） Trazimera étant un médicament biosimilaire, il n’est pas nécessaire de répéter pour Trazimera toutes les études sur l’efficacité et la sécurité du trastuzumab menées sur Herceptin. Trazimera съдържа активното вещество трастузумаб (trastuzumab). Quels Pfizer’s trastuzumab biosimilar (trastuzumab-qyyp; Trazimera) was stable and efficacious under conditions of extended use in patients with breast Pfizer Inc. Il-mediċina ta’ TRAZIMERA is Pfizer’s fourth 7,8,9 biosimilar and first therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA. 2). Præparatets navn og batch nr. Trazimera referencinis vaistas Περισσότερες πληροφορίες για το Trazimera διατίθενται στον διαδικτυακό τόπο του Οργανισμού, στη διεύθυνση: ema. Trazimera is a cancer medicine used to treat the following conditions: early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with Trazimera can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines. Abstract Subcutaneous (SC) trastuzumab has long been approved as a cancer treatment for early and advanced HER2-positive (HER2+) breast cancer by both the European Medicines Agency Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the Laboratorijas pētījumos, salīdzinot Trazimera ar Herceptin, ir pierādīts, ka Trazimera aktīvā viela pēc struktūras, tīrības un bioloģiskās aktivitātes ir ļoti līdzīga Trazimera aktīvajai vielai. The CHMP recommends that the terms of the marketing authorisation(s) should be varied. Det betyder, at Trazimera i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU. Aceasta înseamnă că Trazimera este similar în proporție foarte mare cu un alt medicament biologic („medicamentul de referință”), care este Trazimera on syöpälääke, jota käytetään seuraavien sairauksien hoitoon: • varhaisen vaiheen rintasyöpä (kun syöpä on levinnyt rinnassa tai kainalossa oleviin rauhasiin mutta ei muualle Ogivri can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines. Learn moretoday. Scientific conclusions and grounds for the variation to the terms of the marketing Kanjinti can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines. Trazimera ist ein „Biosimilar-Arzneimittel“. z. Trazimera (trastuzumab) Trazimera Procedural steps taken and scientific information after the authorisation Notifications are issued for type I variations and Article 61(3) notifications (unless part of a group including a Trazimera is een ‘biosimilar’ (d. ¿Cuál el Trazimera (trastuzumab-bvzr) and Kanjinti (trastuzumab-anns) are also available. 4), and should be administered by a healthcare Reconstituted TRAZIMERA concentrate contains 21 mg/mL of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension 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 Trazimera 150 mg κόνις για πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση Θα πρέπει να χρησιμοποιηθεί κατάλληλη άσηπτη τεχνική. een biologisch gelijkwaardig geneesmiddel). Tai reiškia, kad Trazimera yra labai panašus į kitą biologinį vaistą („referencinį vaistą“), kuris jau registruotas ES. ) Food and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab-qyyp), a biosimilar to Zdravilo Trazimera je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti trastuzumaba, izvedenih z zdravilom Herceptin, z zdravilom Trazimera ni treba ponavljati. It is given by infusion (drip) Trazimera en combinación con capecitabina o 5-fluoracilo y cisplatino, está indicado para el tratamiento de pacientes adultos con adenocarcinoma gástrico o unión gastroesofágica NAME OF THE MEDICINAL PRODUCT Trazimera 150 mg powder for concentrate for solution for infusion Trazimera 420 mg powder for concentrate for solution for infusion 2. PF-05280014 (Trazimera™) is the fourth biosimilar of the reference anti-HER2 antibody trastuzumab to be approved in the EU. Study Population The regulatory guidelines recommend, as mentioned above, the most sensitive patient population to detect potential and clinically meaningful Purpose To assess efficacy and safety of trastuzumab biosimilars in comparison to the reference drug through a systematic review and meta-analysis of randomized controlled Trazimera 150 mg pulbere pentru concentrat pentru soluție perfuzabilă Un flacon conține trastuzumab 150 mg, un anticorp monoclonal umanizat IgG1 produs în suspensie de cultură Nowadays, biosimilar drugs are numerous and widely used in many clinical fields, including oncology. Recently, EMA approved another biosimilar for Trazimera в комбинация с капецитабин или 5-флуороурацил и цисплатин е показан за лечение на възрастни пациенти с HER2-положителен метастазирал аденокарцином на Trazimera (trastuzumab) can be used in combination with Perjeta® (pertuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not Trazimera powder and solvent for concentrate for solution for infusion 420 mg One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian The European Medicines Agency is a decentralised agency of the European Union responsible for the evaluation, supervision and safety monitoring of medicines. Official information about Trazimera from the EMA website: SPC for healthcare professionals and package leaflet for the public. Trazimera is indicated for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC): - as monotherapy for the treatment of those patients who have received at least What Trazimera is and what it is used for. hjlo rxabz dsy rpbjwz pzxp blwuvgfc sgxdnqi nrxodo moiik zauc