Európai Unió - dán - EMA (European Medicines Agency)

janssen cilag international nv - miglustat - gaucher disease; niemann-pick diseases - andre alimentary tract and metabolism produkter, - zavesca er indiceret til oral behandling af voksne patienter med mild til moderat type 1-gauchers sygdom. zavesca må kun anvendes til behandling af patienter, for hvilke enzymetilskuddsterapi er uegnet. zavesca er indiceret til behandling af progressive neurologiske forstyrrelser hos voksne patienter, og pædiatriske patienter med niemann-pick type-c sygdom.

Európai Unió - dán - EMA (European Medicines Agency)

janssen-cilag international nv - guselkumab - psoriasis - immunosuppressiva - 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.

Európai Unió - dán - EMA (European Medicines Agency)

janssen-cilag international nv - apalutamide - prostatiske neoplasmer - endokrine terapi - erleada er anført:i voksne mænd til behandling af ikke-metastatisk kastration resistent prostatakræft (nmcrpc), som er i høj risiko for at udvikle metastatisk sygdom. hos voksne mænd til behandling af metastatisk hormon-følsomme prostatakræft (mhspc) i kombination med androgen deprivation terapi (adt).

Európai Unió - dán - EMA (European Medicines Agency)

janssen-cilag international nv - esketamine hydrochlorid - depressiv lidelse - andre antidepressiva - spravato, i kombination med en ssri eller snri, er angivet for voksne med behandling-resistent depressiv lidelse, der ikke har reageret på mindst to forskellige behandlinger med antidepressiva i den nuværende moderat til svær depressiv episode.

Európai Unió - dán - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant adenovirus type 26 (ad26) encoding the glycoprotein (gp) of the ebola virus zaire (zebov) mayinga strain - hæmoragisk feber, ebola - vacciner - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Európai Unió - dán - EMA (European Medicines Agency)

janssen-cilag international n.v.    - recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp - hæmoragisk feber, ebola - vacciner - active immunization for prevention of disease caused by ebola virus (zaire ebolavirus species) in individuals ≥ 1 year of age.

Európai Unió - dán - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - carcinom, ikke-småcellet lunge - antineoplastiske midler - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Európai Unió - dán - EMA (European Medicines Agency)

janssen-cilag international nv - ciltacabtagene autoleucel - multipelt myelom - 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.

Európai Unió - dán - EMA (European Medicines Agency)

janssen-cilag international n.v. - teclistamab - multipelt myelom - antineoplastiske midler - tecvayli is indicated as monotherapy 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.

Európai Unió - dán - EMA (European Medicines Agency)

janssen-cilag international n.v. - abiraterone acetate, niraparib tosilate monohydrate - prostatic neoplasmer, kastration-resistent - antineoplastiske midler - treatment of adult patients with prostate cancer.