Řecko - řečtina - Εθνικός Οργανισμός Φαρμάκων

novartis europharm limited, ireland (0000013045) vista building, elm park, merrion road, dublin 4, - - ranibizumab - ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ - 10mg/ml - 0347396821 ranibizumab 10.000000 mg - ranibizumab

Evropská unie - řečtina - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Αντινεοπλασματικοί παράγοντες - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. Για περισσότερες πληροφορίες σχετικά με την κατάσταση του υποδοχέα 2 του ανθρώπινου επιδερμικού αυξητικού παράγοντα (her2), παρακαλούμε ανατρέξτε στην ενότητα 5. abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. Για περισσότερες πληροφορίες σχετικά με την κατάσταση her2, ανατρέξτε στην ενότητα 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Evropská unie - řečtina - EMA (European Medicines Agency)

ucb pharma s.a. - romosozumab - Οστεοπόρωση - Φάρμακα για τη θεραπεία ασθενειών των οστών - evenity ενδείκνυται στην θεραπεία της σοβαρής οστεοπόρωσης σε μετεμμηνοπαυσιακές γυναίκες με υψηλό κίνδυνο κατάγματος.

Evropská unie - řečtina - EMA (European Medicines Agency)

gilead sciences ireland uc - sacituzumab govitecan - breast neoplasms; triple negative breast neoplasms - Αντινεοπλασματικοί παράγοντες - trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mtnbc) who have received two or more prior systemic therapies, including at least one of them for advanced disease.

Evropská unie - řečtina - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - Αντινεοπλασματικοί παράγοντες - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. Ασθενείς με egfr ή alk θετική καρκινικών μεταλλάξεων θα πρέπει επίσης να έχουν λάβει στοχευμένη θεραπεία πριν από τη λήψη keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Řecko - řečtina - Εθνικός Οργανισμός Φαρμάκων

ΙΦΕΤ ΑΕ 18ο χλμ. Λεωφ. Μαραθώνος,, 153 51 153 51, Παλλήνη Αττικής 210.6603400-6603522 - ocrelizumab - c/s.sol.in (ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 300mg/10ml (30mg/ml) - ocrelizumab 300mg - ocrelizumab

Řecko - řečtina - Εθνικός Οργανισμός Φαρμάκων

roche pharma ag, grenzach-wyhlen, germany emil-barell-strasse 1, d-79639, grenzach-wylhen - polatuzumab vedotin - pd.i.s.inf (ΚΟΝΙΣ ΓΙΑ ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ/ΔΙΑΛΥΜΑ ΠΡΟΣ ΕΓΧΥΣΗ) - 140mg/vial - polatuzumab vedotin 140mg - polatuzumab vedotin

Řecko - řečtina - Εθνικός Οργανισμός Φαρμάκων

alexion europe sas, france 103-105 rue anatole france, 92300 levallois-perret - ravulizumab - c/s.sol.in (ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 300mg/30ml (10mg/ml) - ravulizumab 300mg - ravulizumab

Řecko - řečtina - Εθνικός Οργανισμός Φαρμάκων

gilead sciences ireland uc, co. cork, ireland ida business and technology park, - co. cork - sacituzumab govitecan - pd.c.so.in (ΚΟΝΙΣ ΓΙΑ ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 200 mg/vial - sacituzumab govitecan 200mg - sacituzumab govitecan

Řecko - řečtina - Εθνικός Οργανισμός Φαρμάκων

roche registration ltd, u.k. 6 falcon way, shire park,, welwyn garden city, al7 1tw, u.k. - trastuzumab emtansine - pd.c.so.in (ΚΟΝΙΣ ΓΙΑ ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 160mg/vial - trastuzumab emtansine 160mg - trastuzumab emtansine