Unjoni Ewropea - Daniż - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - antineoplastiske midler - breast cancermetastatic breast cancer zercepac 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 two chemotherapy regimens for their metastatic disease. før kemoterapi skal have omfattet mindst en antracyklin og en taxane medmindre patienter, der er uegnede til disse behandlinger. hormon-receptor-positive patienter skal også have undladt hormonbehandling, medmindre patienter, der er uegnede til disse behandlinger.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. i kombination med docetaxel til behandling af de patienter, der ikke har fået kemoterapi for deres metastatisk sygdom. i kombination med en aromatase inhibitor til behandling af postmenopausale patienter med hormon-receptor positiv mbc, der ikke tidligere er behandlet med trastuzumab. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). følgende kirurgi, kemoterapi (neoadjuverende eller adjuvans) og strålebehandling (hvis relevant). efter adjuverende kemoterapi med doxorubicin og cyclophosphamid, i kombination med paclitaxel eller docetaxel. i kombination med adjuverende kemoterapi, der består af docetaxel og carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac 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 gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. præcise og validerede analyse metoder, der bør anvendes.

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

actavis group ptc ehf. - gemcitabinhydrochlorid - koncentrat til infusionsvæske, opløsning - 40 mg/ml

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

medac gesellschaft für klinische - gemcitabinhydrochlorid - koncentrat til infusionsvæske, opløsning - 38 mg/ml

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

stada arzneimittel ag - gemcitabinhydrochlorid - pulver til infusionsvæske, opløsning - 200 mg

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

sun pharmaceutical industries - gemcitabinhydrochlorid - pulver til infusionsvæske, opløsning - 200 mg

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

fresenius kabi ab - gemcitabinhydrochlorid - koncentrat til infusionsvæske, opløsning - 40 mg/ml

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

teva b.v. - gemcitabinhydrochlorid - koncentrat til infusionsvæske, opløsning - 40 mg/ml

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

actavis group ptc ehf. - gemcitabinhydrochlorid - koncentrat til infusionsvæske, opløsning - 40 mg/ml

Danimarka - Daniż - Lægemiddelstyrelsen (Danish Medicines Agency)

mylan ab - sorafenibtosylat - filmovertrukne tabletter - 200 mg

Unjoni Ewropea - Daniż - EMA (European Medicines Agency)

astrazeneca ab - gefitinib - carcinom, ikke-småcellet lunge - antineoplastiske midler - iressa er indiceret til behandling af voksne patienter med lokalt fremskreden eller metastatisk ikke-small-cell lung cancer med aktiverende mutationer af epidermal-growth-factor-receptor tyrosin kinase.