Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva สหภาพยุโรป - สโลวีเนีย - EMA (European Medicines Agency)

efavirenz/emtricitabine/tenofovir disoproxil zentiva

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil phosphate - okužbe z virusom hiv - antivirusi za sistemsko uporabo - efavirenz/emtricitabine/so disoproxil zentiva je določen odmerek kombinacija efavirenz, emtricitabine in so disoproxil. to je indicirano za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti-1 (hiv-1) pri odraslih, starih 18 let in več z virologic zatiranje ravnem hiv-1 rna < 50 kopij/ml na njihovi trenutni kombinirano protiretrovirusno zdravljenje za več kot tri mesece. bolniki ne smejo imeti izkušene virological neuspeh na predhodno antiretrovirusne terapije in mora biti znano, da niso harboured virus sevi z mutacije, ki prenašajo pomembno odpornost na katero koli od treh komponent iz efavirenz/emtricitabine/tenofovir disoproxil zentiva pred začetkom njihovega prvega protiretrovirusno zdravljenje režim. predstavitev koristi kombinacija efavirenz/emtricitabine/tenofovir disoproxil je v prvi vrsti temelji na 48-tedenski podatki iz kliničnih študij, v katerih so bolniki s stabilno virologic zatiranje na kombinaciji antiretrovirusne terapije spremeniti, da efavirenz/emtricitabine/tenofovir disoproxil. ni podatkov, ki so trenutno na voljo iz kliničnih študij s kombinacijo efavirenz/emtricitabine/tenofovir disoproxil v zdravljenje-naivna ali v močno pretreated bolnikov. ni na voljo so podatki za podporo kombinacija efavirenz/emtricitabine/tenofovir disoproxil in drugimi protiretrovirusnimi agenti.

Pheburane สหภาพยุโรป - สโลวีเนีย - EMA (European Medicines Agency)

pheburane

eurocept international b. v. - natrijev phenylbutyrate - carbamoyl-fosfat sintetaze sem pomanjkljivost bolezni - različne zdravljene bolezni prebavil in presnove izdelki - zdravljenje kroničnih upravljanje sečnine-cikel motnje.

Tigecycline Accord สหภาพยุโรป - สโลวีเนีย - EMA (European Medicines Agency)

tigecycline accord

accord healthcare s.l.u. - tigecycline - soft tissue infections; intraabdominal infections; bacterial infections; skin diseases, infectious - antibacterials za sistemsko uporabo, - tygecycline soglasju je navedeno v odrasle in otroke, starejše od osem let za zdravljenje naslednjih okužb (glej točki 4. 4 in 5. 1):zapleteno, kože in mehkih tkiv, okužbe (cssti), razen diabetično stopalo okužbe (glejte poglavje 4. 4)zapletena znotraj trebušne okužb (ciai)tygecycline soglasju naj se uporablja le v primerih, ko druge alternativne antibiotiki niso primerni (glej točki 4. 4, 4. 8 in 5. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti.

Jyseleca สหภาพยุโรป - สโลวีเนีย - EMA (European Medicines Agency)

jyseleca

gilead sciences ireland uc, galapagos nv - filgotinib maleate - artritis, revmatoidni - imunosupresivi - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

Nyvepria สหภาพยุโรป - สโลวีเนีย - EMA (European Medicines Agency)

nyvepria

pfizer europe ma eeig  - pegfilgrastim - nevtropenija - immunostimulants, - skrajšanje trajanja nevtropenija in pojavnost vročinskih nevtropenija pri odraslih bolnikih, zdravljenih s citotoksično kemoterapijo za malignosti (razen kronično mieloično levkemijo in mielodisplastični sindrom).

Roclanda สหภาพยุโรป - สโลวีเนีย - EMA (European Medicines Agency)

roclanda

santen oy - latanoprost, netarsudil mesilate - glaucoma, open-angle; ocular hypertension - oftalmologi - roclanda is indicated for the reduction of elevated intraocular pressure (iop) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient iop reduction.

Enhertu สหภาพยุโรป - สโลวีเนีย - EMA (European Medicines Agency)

enhertu

daiichi sankyo europe gmbh - trastuzumab deruxtecan - neoplazme dojke - antineoplastična sredstva - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Imcivree สหภาพยุโรป - สโลวีเนีย - EMA (European Medicines Agency)

imcivree

rhythm pharmaceuticals netherlands b.v. - setmelanotide - debelost - preparati za zaščito proti sončenju, prehrambeni izdelki - imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed bardet biedl syndrome (bbs), loss-of-function biallelic pro-opiomelanocortin (pomc), including pcsk1, deficiency or biallelic leptin receptor (lepr) deficiency in adults and children 6 years of age and above.

Carvykti สหภาพยุโรป - สโลวีเนีย - EMA (European Medicines Agency)

carvykti

janssen-cilag international nv - ciltacabtagene autoleucel - multiple myeloma - carvykti is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-cd38 antibody and have demonstrated disease progression on the last therapy.

Atosiban SUN สหภาพยุโรป - สโลวีเนีย - EMA (European Medicines Agency)

atosiban sun

sun pharmaceutical industries europe b.v. - atosiban (as acetate) - predčasno rojstvo - drugi gynecologicals - atosiban je navedeno, da odloži neposredno pred rokom rodila pri nosečnicah odrasle ženske z:redni kontrakcije maternice najmanj 30 sekund trajanje na hitrost ≥ 4 na 30 minut;materničnega vratu dilatacija 1 do 3 cm (0-3 za nulliparas) in effacement ≥ 50%;gestacijske starosti od 24 do 33 končana tednov;običajno plod srčni utrip.