Intrinsa Unia Europejska - norweski - EMA (European Medicines Agency)

intrinsa

warner chilcott uk ltd. - testosteron - seksuelle dysfunksjoner, psykologisk - sex hormoner og modulatorer av genital systemet, - intrinsa er indisert for behandling av hypoactive seksuell lyst lidelse (hsdd) i bilateralt oophorectomised og hysterectomised (kirurgisk indusert overgangsalder) kvinner mottar samtidig estrogen terapi.

Kanuma Unia Europejska - norweski - EMA (European Medicines Agency)

kanuma

alexion europe sas - sebelipase alfa - lipid metabolisme, medfødt feil - andre alimentary tract and metabolism products, - kanuma er indisert for langsiktig enzymutskiftningsterapi (ert) hos pasienter i alle aldre med lysosomal syre lipase (lal) mangel.

Nordimet Unia Europejska - norweski - EMA (European Medicines Agency)

nordimet

nordic group b.v. - methotrexate - arthritis, psoriatic; psoriasis; arthritis, juvenile rheumatoid; arthritis, rheumatoid - antineoplastiske midler - nordimet is indicated for the treatment of:active rheumatoid arthritis in adult patients,polyarthritic forms of severe, active juvenile idiopathic arthritis (jia), when the response to nonsteroidal anti-inflammatory drugs (nsaids) has been inadequate,moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.

Zalmoxis Unia Europejska - norweski - EMA (European Medicines Agency)

zalmoxis

molmed spa - allogene t celler genmodifiserte med en retroviral vektor koding for en avkortet form for menneskelig lav affinitet nerve vekstfaktor reseptor (Δlngfr) og herpes simplex jeg virus thymidine kinase (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastiske midler - zalmoxis er angitt som tilleggsbehandling behandling i haploidentical haematopoietic stilk cellen transplantasjon (hsct) av voksen pasienter med høy risiko hematologisk malignitet.

TachoSil Unia Europejska - norweski - EMA (European Medicines Agency)

tachosil

corza medical gmbh - human fibrinogen, human trombin - hemostase, kirurgisk - antihemoragika - tachosil is indicated in adults and children from 1 month of age for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. tachosil is indicated in adults for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.

Revolade Unia Europejska - norweski - EMA (European Medicines Agency)

revolade

novartis europharm limited - eltrombopag - purpura, trombocytopenisk, idiopatisk - other systemic hemostatics, antihemorrhagics - revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (itp) who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 og 5. revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (itp) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. corticosteroids, immunoglobulins) (see sections 4. 2 og 5. revolade is indicated in adult patients with chronic hepatitis c virus (hcv) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. revolade is indicated in adult patients with acquired severe aplastic anaemia (saa) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.

Tecfidera Unia Europejska - norweski - EMA (European Medicines Agency)

tecfidera

biogen netherlands b.v. - dimetylfumarat - multippel sklerose - immunsuppressive - tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Raplixa Unia Europejska - norweski - EMA (European Medicines Agency)

raplixa

mallinckrodt pharmaceuticals ireland limited - human fibrinogen, human trombin - hemostase, kirurgisk - antihemoragika - støttende behandling der standard kirurgiske teknikker er utilstrekkelige for forbedring av hemostase. raplixa må brukes i kombinasjon med en godkjent gelatin svamp. raplixa er indisert hos voksne over 18 år.

Vaxelis Unia Europejska - norweski - EMA (European Medicines Agency)

vaxelis

mcm vaccine b.v. - difteri toxoid, stivkrampe toxoid, bordetella kikhoste antigener: kikhoste toxoid, trådformede haemagglutinin, pertactin, fimbriae av type 2 og 3, hepatitt b-overflateantigen produsert i gjærceller, poliovirus (inaktivert): type 1 (mahoney), type 2 (mef-1), type 3 (saukett) er produsert i vero-celler/ haemophilus influenzae type b polysakkarid (polyribosylribitol fosfat) conjugated å meningokokk protein. - meningitis, haemophilus; poliomyelitis; tetanus; diphtheria; whooping cough; hepatitis b - vaksiner - vaxelis (dtp-hb-ipv-hib) er angitt for primær og økte vaksinasjon hos spedbarn og småbarn fra alderen 6 uker, mot difteri, tetanus, kikhoste, hepatitt b, poliomyelitt og invasive sykdommer forårsaket av haemophilus influenzae type b (hib). bruk av vaxelis skal være i samsvar med offisielle anbefalinger.

Jylamvo Unia Europejska - norweski - EMA (European Medicines Agency)

jylamvo

therakind (europe) limited - methotrexate - arthritis, psoriatic; precursor cell lymphoblastic leukemia-lymphoma; psoriasis; arthritis, rheumatoid; arthritis - antineoplastiske midler - i rheumatological og dermatologiske diseasesactive revmatoid artritt hos voksne pasienter. polyarthritic former for aktiv, alvorlig juvenil idiopatisk artritt (jia) i ungdom og barn i alderen 3 år og over når respons til ikke-steroidal anti-inflammatorisk legemidler (nsaids) har vært mangelfull. alvorlige, behandling-ildfaste, invalidiserende psoriasis som ikke responderer tilstrekkelig til andre former for behandling, for eksempel lysbehandling, psoralen og uv-a stråling (puva) terapi og retinoider, og alvorlig psoriasis artritt hos voksne pasienter. i oncologymaintenance behandling av akutt lymfoblastisk leukemi (all) hos voksne, ungdom og barn i alderen 3 år og over.