欧盟 - 波兰文 - 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 - Środki przeciwnowotworowe - 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. w celu uzyskania dalszych informacji na temat statusu ludzkiego receptora naskórkowego czynnika wzrostu 2 (her2), patrz punkt 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. więcej informacji na temat statusu her2 można znaleźć w rozdziale 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.

欧盟 - 波兰文 - EMA (European Medicines Agency)

pfizer europe ma eeig - bevacizumab - colorectal neoplasms; breast neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Środki przeciwnowotworowe - zirabev w połączeniu z fluoropyrimidine podstawie chemioterapia jest wskazany w leczeniu dorosłych pacjentów z przerzutami raka okrężnicy lub odbytnicy. zirabev w połączeniu z produkcja jest wskazany w leczeniu pierwszego rzutu u dorosłych pacjentów z przerzutowym rakiem piersi . aby uzyskać więcej informacji jak do ludzkiego receptora naskórkowego czynnika wzrostu 2 (her2) status. zirabev, w dodatku do opierająca się chemoterapia, przeznaczony dla pierwszej linii terapii dorosłych pacjentów z нерезектабельными-powszechne, przerzutowym lub nawracające niedrobnokomórkowego raka płuc, niż inne w zasadzie плоскоклеточной histologią. zirabev w połączeniu z interferonem alfa-2a jest przeznaczony dla pierwszej linii leczenia dorosłych pacjentów z zaawansowanym lub przerzutowym nerki-komórkowej raka. zirabev, w połączeniu z mzios i cisplatyną lub mzios i topotekanom u pacjentów, którzy nie mogą otrzymać platynową terapię, jest wskazany w leczeniu dorosłych chorych na przewlekłe, nawracające lub przerzutami raka szyjki macicy.

欧盟 - 波兰文 - EMA (European Medicines Agency)

merck europe b.v.  - cetuksymab - head and neck neoplasms; colorectal neoplasms - Środki przeciwnowotworowe - erbitux jest wskazany do leczenia pacjentów z receptora naskórkowego czynnika wzrostu (egfr)-wyrażenie, ras dzikiego typu przerzuty raka jelita grubego:w połączeniu z irinotekanem podstawie chemioterapii;w pierwszej linii w połączeniu z folfox;w monoterapii u pacjentów, którzy nie oksaliplatyna - i irynotekanu-terapia i kto jest nietolerancyjny do иринотекану. więcej informacji można znaleźć w rozdziale 5. erbitux jest wskazany do leczenia pacjentów z плоскоклеточным rakiem głowy i szyi w skojarzeniu z radioterapią w miejscowo-najczęstszych chorób;w połączeniu z chemoterapią na bazie platyny dla powtarzających się i/lub rozsiana choroba.

欧盟 - 波兰文 - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - niwolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - Środki przeciwnowotworowe - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

波兰 - 波兰文 - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

adamed pharma s.a. - candesartanum cilexetili + amlodipini besilas - kapsułki twarde - 8 mg + 5 mg

波兰 - 波兰文 - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

adamed pharma s.a. - candesartanum cilexetili + amlodipini besilas - kapsułki twarde - 8 mg + 10 mg

波兰 - 波兰文 - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

adamed pharma s.a. - candesartanum cilexetili + amlodipinum - kapsułki twarde - 16 mg + 10 mg

波兰 - 波兰文 - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

adamed pharma s.a. - candesartanum cilexetili + amlodipini besilas - kapsułki twarde - 16 mg + 5 mg

波兰 - 波兰文 - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

phytopharm klęka s.a. - aloes arborescentis recentis extractum fluidum + acidum ascorbicum - syrop - (1920 mg + 51 mg)/5 ml

波兰 - 波兰文 - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

polfarmex s.a. - salmeterolu ksynafonian - proszek do inhalacji, podzielony - 50 mcg/dawkę inh.