Evropská unie - polština - EMA (European Medicines Agency)

pfizer limited - difloksacyna - Środki antybakteryjne do stosowania systemowego, противоинфекционные dla systemowego użycia - turkeys; dogs; cattle; chicken - kurczaki:do leczenia przewlekłych zakażeń układu oddechowego wywołanych przez wrażliwe szczepy escherichia coli i mykoplazmy галисептикум . indyki: w leczeniu przewlekłych infekcji dróg oddechowych wywołanych przez wrażliwe szczepy escherichia coli i mycoplasma gallisepticum. również do leczenia infekcji wywołanych przez pasteurella multocida. psy: do leczenia ostrych nieskomplikowanych infekcji dróg moczowych wywołanych przez escherichia coli lub staphylococcus spp. i powierzchowna ropne zapalenie skóry wywołane przez staphylococcus intermedius. hodowla:do leczenia chorób układu oddechowego bydła (wysyłka gorączka, kawioru, zapalenie płuc), spowodowane przez pojedynczych lub mieszanych infekcji bakterie pasteurella haemolytica, bakterie pasteurella multocida i / lub mycoplasma spp.

Evropská unie - polština - EMA (European Medicines Agency)

virbac s.a. - rekombinowany interferon omega pochodzenia kociego - Иммуностимуляторы, - dogs; cats - dogsreduction of mortality and clinical signs of parvovirosis (enteric form) in dogs from one month of age. catstreatment of cats infected with feline leukaemia virus (felv) and / or feline immunodeficiency virus (fiv), in non-terminal clinical stages, from the age of nine weeks. in a field study conducted, it was observed that there was:a reduction of clinical signs during the symptomatic phase (four months);a reduction of mortality:in anaemic cats, mortality rate of about 60% at four, six, nine and 12 months was reduced by approximately 30% following treatment with interferon;in non-anaemic cats, mortality rate of 50% in cats infected by felv was reduced by 20% following treatment with interferon. u kotów zakażonych fiv śmiertelność była niska (5%) i nie była zależna od leczenia.

Evropská unie - polština - EMA (European Medicines Agency)

merck sharp & dohme b.v. - Пембролизумаб - 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 - Środki przeciwnowotworowe - 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. pacjenci z egfr lub АЛК pozytywnej guza mutacje muszą także otrzymywali таргетную terapię aż do uzyskania Кейтруда. 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.

Evropská unie - polština - EMA (European Medicines Agency)

novartis europharm limited - trametynib - czerniak - Środki przeciwnowotworowe - melanomatrametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a braf v600 mutation (see sections 4. 4 i 5. trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior braf inhibitor therapy (see section 5. adjuvant treatment of melanomatrametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with stage iii melanoma with a braf v600 mutation, following complete resection. niedrobnokomórkowego raka płuca (nsclc)trametinib w połączeniu z dabrafenib jest wskazany do leczenia dorosłych pacjentów z postępowym małym komórka nowotworem płuc z brugh mutacja v600 daleko .

Evropská unie - polština - EMA (European Medicines Agency)

actavis group ptc ehf - topotekan - uterine cervical neoplasms; small cell lung carcinoma - Środki przeciwnowotworowe - topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5. topotekanu w połączeniu z cisplatyną jest wskazany dla pacjentów z rakiem nawracające szyjki macicy po radioterapii dla pacjentów stadium choroby, ИВБ . patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.

Evropská unie - polština - EMA (European Medicines Agency)

pfizer limited - sunitinib - gastrointestinal stromal tumors; carcinoma, renal cell; neuroendocrine tumors - Środki przeciwnowotworowe - gastrointestinal stromal tumour (gist)sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (gist) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. metastatic renal cell carcinoma (mrcc)sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (mrcc) in adults. pancreatic neuroendocrine tumours (pnet)sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. experience with sutent as first-line treatment is limited (see section 5.

Evropská unie - polština - EMA (European Medicines Agency)

sandoz gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - Иммуностимуляторы, - skrócenie czasu trwania neutropenii i częstotliwości gorączkowe neutropenii u pacjentów z zamontowanymi chemioterapii na nowotwory złośliwe (za wyjątkiem chroniczna myeloid białaczki i миелодиспластических zespołów), a także skrócenie czasu trwania neutropenii u pacjentów, otrzymujących leczenie mieloablativnuû przeszczep szpiku kostnego jest zwiększone ryzyko długotrwałej ciężkiej neutropenii. bezpieczeństwo i skuteczność filgrastymu są podobne u dorosłych i dzieci otrzymujących chemioterapię cytotoksyczną. mobilizacja komórek progenitorowych krwi obwodowej (pbpc). u dzieci i dorosłych z ciężką wrodzoną, cyklicznej lub idiopatyczną neutropenią, bezwzględna liczba neutrofili (anc) ≤0. 5 x 109/l, i w historii ciężkie lub nawracające infekcje, długotrwałego stosowania filgrastim wskazuje na wzrost neutrofilów i zmniejszyć częstotliwość i czas trwania zakaźnych zdarzeń. leczenie odpornej neutropenii (cns ≤ 1. 0 x 109/l) u pacjentów z zaawansowanym stadium zakażenia wirusem hiv, w celu zmniejszenia ryzyka zakażeń bakteryjnych, gdy inne lecznicze opcje niesłuszna.

Evropská unie - polština - EMA (European Medicines Agency)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - Środki przeciwnowotworowe - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Evropská unie - polština - EMA (European Medicines Agency)

roche registration gmbh  - пертузумаб - nowotwory piersi - antineoplastic agents, monoclonal antibodies - przerzuty raka piersi:perjeta jest wskazany do stosowania w połączeniu z trastuzumabom i docetakselem u dorosłych pacjentów z her2-dodatnim przerzutami lub miejscowo-powszechne нерезектабельным rakiem piersi, które nie otrzymały poprzednie anty-her2 terapii lub chemioterapii dla rozsiana choroba. Неоадъювантного leczenia raka piersi perjeta jest wskazany do stosowania w połączeniu z trastuzumabom i chemoterapią dla неоадъювантного leczenia dorosłych pacjentów z her2-dodatnim, lokalnie, zapalnych, lub wczesnym stadium raka piersi z wysokim ryzykiem nawrotu.

Evropská unie - polština - EMA (European Medicines Agency)

merck sharp & dohme b.v. - efawirenz - infekcje hiv - Środki przeciwwirusowe do użytku ogólnoustrojowego - preparat stocrin jest wskazany w leczeniu skojarzonym dorosłych, młodzieży i dzieci w wieku trzech lat i starszych zakażonych ludzkim niedoborem odporności-wirus-1 (hiv-1). Стокрин nie zostały odpowiednio zbadane w pacjentach z zaawansowanym stadium zakażenia hiv, a mianowicie u pacjentów z poziomem cd4 < 50 komórek/mm3, lub po niepowodzeniu proteazy-inhibitor (pi)-zawierający schematów. chociaż oporności krzyżowej èfavirenza z ip nie został zarejestrowany, w chwili obecnej nie ma wystarczających danych na temat skuteczności późniejszego wykorzystania pi na podstawie połączenie terapii nieskuteczność schematów zawierających Стокрин.