Kolbam यूरोपीय संघ - डेनिश - EMA (European Medicines Agency)

kolbam

retrophin europe ltd - cholsyre - metabolisme, infødte fejl - galde og lever terapi - cholic syre fgk er indiceret til behandling af medfødte fejl af primær galdesyre syntese, i spædbørn fra én måneds alder til kontinuerlig livslang behandling gennem voksenalderen, omfatter følgende enkelt enzym fejl:sterol-27-hydroxylase (fremlægger som cerebrotendinous xanthomatosis, ctx) mangel;2- (eller alpha-) methylacyl-coa racemase (amacr) mangel;kolesterol 7 alfa-hydroxylase (cyp7a1) - mangel.

Temozolomide Sun यूरोपीय संघ - डेनिश - EMA (European Medicines Agency)

temozolomide sun

sun pharmaceutical industries europe b.v. - temozolomid - glioma; glioblastoma - antineoplastiske midler - temozolomide sun er indiceret til behandling af:voksne patienter med nyligt diagnosticerede glioblastoma multiforme samtidig med strålebehandling (rt) og efterfølgende som monoterapi behandling;børn fra en alder af tre år, unge og voksne patienter med ondartet gliom, såsom glioblastoma multiforme eller anaplastisk astrocytom, der viser recidiv eller progression efter standardbehandling.

Vaborem यूरोपीय संघ - डेनिश - EMA (European Medicines Agency)

vaborem

menarini international operations luxembourg s.a. - meropenem trihydrat, vaborbactam - urinary tract infections; bacteremia; bacterial infections; respiratory tract infections; pneumonia; pneumonia, ventilator-associated - antibakterielle midler til systemisk brug, - vaborem er indiceret til behandling af følgende infektioner hos voksne:kompliceret urinvejsinfektion (cuti), herunder pyelonephritiscomplicated intra-abdominal infektion (ciai)hospitals-erhvervet pneumoni (hap), herunder ventilator associeret pneumoni (vap). behandling af patienter med bacteraemia, der opstår i forbindelse med, eller er mistænkt for at være forbundet med nogen af de infektioner, der er anført ovenfor. vaborem er også indiceret til behandling af infektioner på grund af aerobe gram-negative organismer i voksne med begrænsede behandlingsmuligheder. det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

Aftovaxpur DOE यूरोपीय संघ - डेनिश - EMA (European Medicines Agency)

aftovaxpur doe

boehringer ingelheim vetmedica gmbh - højst tre af følgende renset, inaktiveret, mund-og klovesyge virus-stammer: o1 manisa ≥ 6 pd50*; o1 bfs ≥ 6 pd50*; o taiwan 3/97 ≥ 6 pd50*; a22 irak ≥ 6 pd50*; a24 cruzeiro ≥ 6 pd50*; en kalkun 14/98 ≥ 6 pd50*; asien 1 shamir ≥ 6 pd50*; sat2 saudi-arabien ≥ 6 pd50*; * pd50 – 50% beskyttende dosis i kvæg, som er beskrevet i ph. eur. monografi 0063. - immunologiske - pigs; cattle; sheep - aktiv immunisering af kvæg, får og svin fra 2 uger mod mund- og klovesyge for at reducere kliniske tegn.

Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) यूरोपीय संघ - डेनिश - EMA (European Medicines Agency)

lenalidomide krka d.d. novo mesto (previously lenalidomide krka)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - immunosuppressiva - multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) er indiceret til behandling af voksne patienter med tidligere ubehandlet myelomatose, der ikke er berettiget til transplantation. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) er indiceret til behandling af voksne patienter med tidligere ubehandlet myelomatose, der ikke er berettiget til transplantation. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) यूरोपीय संघ - डेनिश - EMA (European Medicines Agency)

lenalidomide krka (previously lenalidomide krka d.d. novo mesto)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; myelodysplastic syndromes; lymphoma, follicular; lymphoma, mantle-cell - immunosuppressiva - multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) er indiceret til behandling af voksne patienter med tidligere ubehandlet myelomatose, der ikke er berettiget til transplantation. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 og 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) er indiceret til behandling af voksne patienter med tidligere ubehandlet myelomatose, der ikke er berettiget til transplantation. lenalidomide krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. mantle cell lymphomalenalidomide krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 og 5. follicular lymphomalenalidomide krka in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Lenalidomide Krka d.d. यूरोपीय संघ - डेनिश - EMA (European Medicines Agency)

lenalidomide krka d.d.

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - immunosuppressiva - multiple myelomalenalidomide krka d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) er indiceret til behandling af voksne patienter med tidligere ubehandlet myelomatose, der ikke er berettiget til transplantation. lenalidomide krka d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

RotaTeq यूरोपीय संघ - डेनिश - EMA (European Medicines Agency)

rotateq

merck sharp & dohme b.v. - rotavirus serotype g1, serotype g2, serotype g3, serotype g4, serotype p1 - immunization; rotavirus infections - vaccines, viral vaccines - rotateq er indiceret til aktiv immunisering af spædbørn fra en alder af seks uger til 32 uger til forebyggelse af gastroenteritis på grund af rotavirusinfektion. rotateq er at blive brugt på grundlag af de officielle anbefalinger.

ProMeris यूरोपीय संघ - डेनिश - EMA (European Medicines Agency)

promeris

pfizer limited  - metaflumizon - ectoparasiticides til udvortes brug, incl. insekticider - katte - behandling og forebyggelse af loppeangreb (ctenocephalides canis og c. felis) hos katte. veterinærlægemidlet kan anvendes som led i en behandlingsstrategi for loppeallergi dermatitis (fad).