Evropská unie - slovenština - EMA (European Medicines Agency)

opk biotech netherlands bv - hemoglobín glutamér-200 (hovädzí dobytok) - krvnÉ nÁhrady a uzÁvery rieŠenia - psy - oxyglobin poskytuje kyslíkovú podporu pre psov, ktoré zlepšujú klinické príznaky anémie najmenej 24 hodín, nezávisle od základných stavov.

Evropská unie - slovenština - EMA (European Medicines Agency)

zoetis belgium sa - selamectin, sarolaner - antiparazitické prípravky, insekticídy a repelenty, macrocyclic laktónov, , kombinácie - mačky - pre mačky s rizikovým alebo zmiešaným parazitným zamorením kličkami a blechami, vši, roztočmi, gastrointestinálnymi nematódami alebo srdcovými červami. veterinárny liek je indikovaný výhradne vtedy, keď sa používa proti kliešťom a jednému alebo viacerým iným cieľovým parazitom.

Evropská unie - slovenština - 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 - antineoplastické činidlá - 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. u pacientov s egfr alebo alkalickÝm pozitívne nádor mutácie by tiež dostali cielenú liečbu pred prijatím 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.

Evropská unie - slovenština - EMA (European Medicines Agency)

eisai gmbh - lenvatinib mesilát - nádory štítnej žľazy - antineoplastické činidlá - lenvima je označené ako monotherapy na liečbu dospelých pacientov s progresívnou, lokálne pokročilým alebo metastatickým, diferencované (papillary/follicular/hürthle bunky) karcinóm štítnej žľazy (dtc), žiaruvzdorné rádioaktívneho jódu (rai). lenvima je označené ako monotherapy na liečbu dospelých pacientov s pokročilým alebo unresectable hepatocellular karcinóm (hcc), ktorí dostali bez predchádzajúceho systémová terapia.

Evropská unie - slovenština - EMA (European Medicines Agency)

astrazeneca ab - olaparib - ovariálne nádory - antineoplastické činidlá - ovariálnych cancerlynparza je označené ako monotherapy pre:udržiavaciu liečbu dospelých pacientov s pokročilým (figo fázy iii a iv) brca1/2-zmutoval (germline a/alebo somatických) high-grade epitelové vaječníkov, fallopian trubice alebo primárne peritoneal rakovine, ktorí sú v reakcii (úplné alebo čiastočné) po ukončení prvej línie platinum-založené chemoterapia. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (figo stages iii and iv) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either a brca1/2 mutation and/or genomic instability (see section 5. breast cancerlynparza is indicated as:monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline brca1/2-mutations who have her2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4. 2 a 5. monotherapy for the treatment of adult patients with germline brca1/2-mutations, who have her2 negative locally advanced or metastatic breast cancer. pacienti by mali mať predtým liečení anthracycline a taxane v (neo)adjuvantnej alebo metastatickým nastavenie pokiaľ pacienti neboli vhodné pre tieto liečby (pozri časť 5. u pacientov s hormonálny receptor (hr)-pozitívnou rakovinou prsníka, by tiež mali mať postupoval alebo po pred žliaz s vnútornou sekréciou, terapie, alebo byť považované za nevhodné pre žliaz s vnútornou sekréciou, terapia. adenocarcinoma of the pancreaslynparza is indicated as:monotherapy for the maintenance treatment of adult patients with germline brca1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. prostate cancerlynparza is indicated as:monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mcrpc) and brca1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mcrpc in whom chemotherapy is not clinically indicated (see section 5.

Evropská unie - slovenština - EMA (European Medicines Agency)

hospira uk limited - docetaxel trihydrát - stomach neoplasms; prostatic neoplasms; breast neoplasms; head and neck neoplasms; carcinoma, non-small-cell lung - antineoplastické činidlá - prsia cancertaxespira v kombinácii s doxorubicin a cyklofosfamidom je indikovaný na adjuvantnej liečby u pacientov s:funkčnom uzol-pozitívnou rakovinou prsníka;funkčnom uzol-negatívne rakovine prsníka. pre pacientov s funkčnom uzol-negatívne rakoviny prsníka, adjuvantná liečba by mala byť obmedzená na pacientov oprávnené prijímať chemoterapia podľa medzinárodne stanovených kritérií pre primárnej liečbe včasného karcinómu prsníka. taxespira v kombinácii s doxorubicin je indikovaný na liečbu pacientov s lokálne pokročilého alebo metastatického karcinómu prsníka, ktorí sa v minulosti nedostali cytotoxické terapia pre tento stav. taxespira monotherapy je indikovaný na liečbu pacientov s lokálne pokročilého alebo metastatického karcinómu prsníka po zlyhaní cytotoxické terapia. predchádzajúca chemoterapia mala zahŕňať antracyklín alebo alkylačné činidlo. taxespira kombinácii s trastuzumab je indikovaný na liečbu pacientov s metastatickým rakoviny prsníka, ktorých nádory nad express her2 a ktoré sa predtým nedostali chemoterapii pre metastatické ochorenie. taxespira v kombinácii s capecitabine je indikovaný na liečbu pacientov s lokálne pokročilého alebo metastatického karcinómu prsníka po zlyhaní cytotoxické chemoterapia. predchádzajúca liečba mala zahŕňať antracyklín. non-small cell lung cancer taxespira indikovaný na liečbu pacientov s lokálne pokročilým alebo metastatickým non-small cell lung cancer po zlyhaní predchádzajúcej chemoterapie. taxespira v kombinácii s cisplatin je indikovaný na liečbu pacientov s unresectable, lokálne pokročilým alebo metastatickým non-small cell lung cancer, u pacientov, ktorí v minulosti boli liečení chemoterapiou, táto podmienka. rakovina prostaty taxespira v kombinácii s prednizónom alebo prednisolone je indikovaný na liečbu pacientov so srdcovo žiaruvzdorné metastatické rakoviny prostaty. Žalúdočné adenocarcinoma taxespira v kombinácii s cisplatin a 5-fluorouracil je indikovaný na liečbu pacientov s metastatickým žalúdočnej adenocarcinoma, vrátane adenocarcinoma z gastroezofageálny križovatke, ktorí nedostali pred chemoterapii pre metastatické ochorenie. nádorov hlavy a krku, taxespira v kombinácii s cisplatin a 5-fluorouracil je indikovaný na indukčnú liečbu pacientov s lokálne pokročilým karcinómom bunky karcinómu hlavy a krku.

Evropská unie - slovenština - EMA (European Medicines Agency)

gilead sciences ireland uc - emtricitabine, rilpivirine hydrochlorid, tenofovir alafenamide - hiv infekcie - antivirotiká na systémové použitie - liečba dospelých a dospievajúcich (vo veku 12 rokov a starších s telesná hmotnosť najmenej 35 kg) infikovaných ľudským vírusom imunodeficiencie 1 (hiv-1) bez známe mutácie spojené s rezistenciou voči non nukleozidový inhibítor reverznej transkriptázy (nnrti) triedy, emtricitabín alebo tenofovir a s vírusové zaťaženie ≤ 100 000 hiv 1 rna kópií/ml.

Evropská unie - slovenština - EMA (European Medicines Agency)

janssen-cilag international nv - simeprevir - hepatitída c, chronická - antivirotiká na systémové použitie - olysio je indikovaný v kombinácii s inými liekmi na liečbu chronickej hepatitídy c (chc) u dospelých pacientov. pre vírusom hepatitídy c (hcv) genotyp konkrétnu činnosť.

Evropská unie - slovenština - EMA (European Medicines Agency)

gilead sciences ireland uc - sofosbuvir - hepatitída c, chronická - antivirotiká na systémové použitie - sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adult and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 a 5. pre vírusom hepatitídy c (hcv) genotyp špecifické činnosti, pozri časť 4. 4 a 5. sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis c (chc) in adults and paediatric patients aged 3 years and above (see sections 4. 2, 4. 4 a 5. pre vírusom hepatitídy c (hcv) genotyp špecifické činnosti, pozri časť 4. 4 a 5.

Evropská unie - slovenština - EMA (European Medicines Agency)

roche registration gmbh - erlotinib - carcinoma, non-small-cell lung; pancreatic neoplasms - antineoplastické činidlá - non-small cell lung cancer (nsclc)tarceva je tiež uvedené, pre prepínanie udržiavaciu liečbu u pacientov s lokálne pokročilým alebo metastatickým non-small cell lung cancer s egfr aktivácia mutácie a stabilné ochorenie po prvej línii chemoterapie. tarceva je tiež indikovaný na liečbu pacientov s lokálne pokročilým alebo metastatickým non-small cell lung cancer po zlyhaní aspoň jedného pred chemoterapiou režim. u pacientov s nádorov bez egfr aktivácia mutácie, tarceva je indikovaná vtedy, keď ostatné možnosti liečby, nie sú považované za vhodné. pri predpisovaní lieku tarceva, faktory spojené s dlhšom prežitie by mali byť brané do úvahy. Č prežitie prospech alebo iných klinicky relevantné účinky liečby boli preukázané u pacientov s epidermálnych growth factor receptor (egfr)-ihc - negatívne nádorov. pankreatických cancertarceva v kombinácii s gemcitabine je indikovaný na liečbu pacientov s metastatickým pankreasu. pri predpisovaní lieku tarceva, faktory spojené s dlhšom prežitie by mali byť brané do úvahy.