Evropska unija - slovenščina - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumine - okužbe, pridobljene v skupnosti - antibacterials za sistemsko uporabo, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 in 5. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Evropska unija - slovenščina - EMA (European Medicines Agency)

takeda pharma a/s - brentuximab vedotin - lymphoma, non-hodgkin; hodgkin disease - antineoplastična sredstva - hodgkin lymphomaadcetris is indicated for adult patients with previously untreated cd30+ stage iv hodgkin lymphoma (hl) in combination with doxorubicin, vinblastine and dacarbazine (avd). adcetris is indicated for the treatment of adult patients with cd30+ hl at increased risk of relapse or progression following autologous stem cell transplant (asct). adcetris is indicated for the treatment of adult patients with relapsed or refractory cd30+ hodgkin lymphoma (hl):following asct, orfollowing at least two prior therapies when asct or multi-agent chemotherapy is not a treatment option. systemic anaplastic large cell lymphomaadcetris in combination with cyclophosphamide, doxorubicin and prednisone (chp) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (salcl). adcetris is indicated for the treatment of adult patients with relapsed or refractory salcl. cutaneous t cell lymphomaadcetris is indicated for the treatment of adult patients with cd30+ cutaneous t cell lymphoma (ctcl) after at least 1 prior systemic therapy.

Evropska unija - slovenščina - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - predkroglomerna limfoblastna levkemija limfoma - antineoplastična sredstva - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Evropska unija - slovenščina - EMA (European Medicines Agency)

pfizer limited - difloksacin - antibacterials za sistemsko uporabo, antiinfectives za sistemsko zdravljenje - turkeys; dogs; cattle; chicken - piščanci:za zdravljenje kroničnih okužb dihal, ki jih povzročajo občutljivi sevi escherichia coli in mikroplazma gallisepticum. puranov:za zdravljenje kroničnih okužb dihal, ki jih povzročajo občutljivi sevi escherichia coli in mikroplazma gallisepticum. tudi za zdravljenje okužb, ki jih povzročajo pasteurella multocida. psi: za zdravljenje akutnih nezapletenih okužb sečil, ki jih povzročajo escherichia coli ali staphylococcus spp. in površinsko piodermo, ki jo povzroča staphylococcus intermedius. govedo:za zdravljenje govedi, bolezni dihal (dostava vročina, tele pljučnica), ki jih povzročajo eno ali mešane okužbe z pasteurella haemolytica, pasteurella multocida in / ali spp mikroplazma.

Evropska unija - slovenščina - EMA (European Medicines Agency)

intervet international bv - ibafloxacin - antibakterij za sistemsko uporabo - dogs; cats - psi:ibaflin je indicirano za zdravljenje naslednjih pogojev pri psih:v stiku s kožo okužb (pyoderma - površinske in globoke rane, abscesi), ki jih povzročajo občutljivi sevi stafilokoki, escherichia coli in proteus mirabilis;akutna, enostavno sečil-trakt okužb, ki jih povzročajo občutljivi sevi stafilokoki, vrste proteus, enterobacter spp. , e. coli in klebsiella spp. ;dihal-trakt okužb (zgornji del prebavil), ki jih povzročajo občutljivi sevi stafilokoki, e. coli in klebsiella spp. ibaflin gel je navedeno pri psih za zdravljenje naslednjih pogojev:v stiku s kožo okužb (pyoderma - površinske in globoke rane, abscesi), ki jih povzročajo občutljivi patogeni, kot so staphylococcus spp. , e. coli in p. mirabilis. mačke:ibaflin gel je navedeno v mačke za zdravljenje naslednjih pogojev:v stiku s kožo okužb (mehka tkiva okužb - rane, abscesi), ki jih povzročajo občutljivi patogeni, kot so staphylococcus spp. , e. coli, proteus spp. in pasteurella spp. ;zgornje dihalne-trakt okužb, ki jih povzročajo občutljivi patogeni, kot so staphylococcus spp. , e. coli, klebsiella spp. in pasteurella spp.

Evropska unija - slovenščina - EMA (European Medicines Agency)

intervet international bv - orbifloxacin, mometasone furoate, posaconazole - otologi - psi - zdravljenje akutni otitis externa in akutne exacerbations ponavljajočih se otitis externa, povezane s bakterije občutljive za orbifloxacin in gliv dovzetni za posaconazole, zlasti malassezia pachydermatis.

Evropska unija - slovenščina - EMA (European Medicines Agency)

bayer animal health gmbh  - pradofloksacin - antibacterials za sistemsko uporabo, fluoroquinolones - dogs; cats - dogstreatment:ran, okužb, ki jih povzročajo občutljivi sevi od staphylococcus intermedius skupino (vključno s. pseudintermedius);površinska in globoka pyoderma, ki jih povzročajo občutljivi sevi od staphylococcus intermedius skupino (vključno s. pseudintermedius);akutna sečil-trakt okužb, ki jih povzročajo občutljivi sevi escherichia coli in staphylococcus intermedius skupino (vključno s. pseudintermedius);kot adjunctive zdravljenje z mehansko ali kirurški periodontal terapija pri zdravljenju hudih okužb gingiva in periodontal tkiv, ki jih povzročajo občutljivi sevi anaerobni organizmi, na primer porphyromonas spp. in prevotella spp. catstreatment akutne okužbe zgornjih dihal, ki jih povzročajo občutljivi sevi pasteurella multocida, escherichia coli in staphylococcus intermedius skupino (vključno s. pseudintermedius).

Evropska unija - slovenščina - 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 - antineoplastična sredstva - 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. pri bolnikih z egfr ali alk pozitivnih tumorjev mutacije, ki naj bi prav tako prejel usmerjena terapija pred prejemom 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.

Evropska unija - slovenščina - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a - levofloksacin - cystic fibrosis; respiratory tract infections - antibacterials za sistemsko uporabo, - quinsair je navedena za upravljanje kronične pljučne okužbe zaradi pseudomonas aeruginosa pri odraslih bolnikih s cistično fibrozo. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

bayer -