Unió Europea - eslovè - EMA (European Medicines Agency)

intervet international b.v - fluralaner - ectoparasiticides za sistemsko uporabo, isoxazolines - dogs; cats - psi:- za zdravljenje klopi in bolh infestations;izdelek se lahko uporablja tudi kot del zdravljenja strategije za nadzor bolh alergija, dermatitis (muha). - za zdravljenje demodicosis zaradi demodex canis;- za zdravljenje sarcoptic mange (sarcoptes scabiei var. canis) okužbe. - for reduction of the risk of infection with babesia canis canis via transmission by dermacentor reticulatus. [chewable tablets only]cats:- for the treatment of tick and flea infestations;the product can be used as part of a treatment strategy for the control of flea allergy dermatitis (fad). - za zdravljenje infestations z uho pršic (otodectes cynotis).

Unió Europea - eslovè - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - 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 - antineoplastična sredstva - 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.

Unió Europea - eslovè - EMA (European Medicines Agency)

merck europe b.v. - avelumab - neuroendokrine tumorje - druga zdravila z delovanjem na novotvorbe agenti, monoklonalna protitelesa - zdravilo bavencio je indicirano za samostojno zdravljenje odraslih bolnikov z metastatskim karcinomom merkelove celice (mcc). bavencio v kombinaciji z axitinib je določen za prvo linijo za zdravljenje odraslih bolnikov z napredovalim karcinomom ledvičnih (rkc). bavencio is indicated as monotherapy for the first‑line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc) who are progression-free following platinum‑based chemotherapy.

Eslovènia - eslovè - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

učinkovina: kalcijev glukonat za injiciranje 380 mg (enakovredno 34 -

Unió Europea - eslovè - EMA (European Medicines Agency)

janssen-cilag international nv - guselkumab - psoriaza - imunosupresivi - plaque psoriasis tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. psoriatic arthritis tremfya, alone or in combination with methotrexate (mtx), is indicated for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (dmard) therapy (see section 5.

Unió Europea - eslovè - EMA (European Medicines Agency)

novartis europharm limited  - onasemnogene abeparvovec - mišična atrofija, hrbtenica - druga zdravila za motnje mišično-skeletnega sistema - zolgensma je primerna za zdravljenje:pri bolnikih z 5q hrbtenice mišična atrofija (sma) z dvo-allelic mutacije v smn1 gena in klinično diagnozo sma tipa 1, orpatients z 5q sma z dvo-allelic mutacije v smn1 gena in do 3 kopije gena smn2.

Unió Europea - eslovè - EMA (European Medicines Agency)

uniqure biopharma b.v.  - alipogen tiparvovec - hiperlipoproteinemija tipa i - sredstva za spreminjanje lipidov - zdravilo glybera je indicirano za odrasle bolnike z diagnozo familialne lipoproteinske lipaze (lpld) in hude ali večkratne napade pankreatitisa, čeprav omejitve maščobnih maščob. diagnozo lpld je treba potrditi z genetskim testiranjem. indikacija je omejena na bolnike z zaznavnimi nivoji beljakovin lpl.

Unió Europea - eslovè - EMA (European Medicines Agency)

elanco gmbh - pegbovigrastim - colony stimulating factors, immunostimulants, zdravila z delovanjem na novotvorbe agenti - cattle (cows and heifers); cattle - kot pomoč v programu za črede zmanjšati tveganje za klinični mastitis v perifernih mlečnih kravah in telicah v 30 dneh po telitvi.

Unió Europea - eslovè - EMA (European Medicines Agency)

elanco gmbh - monensin (kot monensin natrij) - zdravila za preprečevanje in/ali zdravljenje acetonemia - govedo (krave in telice) - za zmanjšanje incidence ketoze v peri-vzrejni kravji / telici za mleko, za katero se pričakuje, da bo razvil ketozo.

Unió Europea - eslovè - EMA (European Medicines Agency)

zoetis belgium sa - Živi aroa geni so bili izbrisani escherichia coli, tip 078, seva ec34195 - immunologicals za aves, Živih bakterijskih cepiv - chicken; turkeys - za aktivno imunizacijo o pitovnih piščancev in prihodnosti plasti / rejcev, da bi zmanjšali umrljivost in poškodb (perikarditis, perihepatitis, airsacculitis), ki je povezana z escherichia coli, serotip o78.