União Europeia - dinamarquês - EMA (European Medicines Agency)

l. molteni & c. dei fratelli alitti società di esercizio s.p.a. - buprenorphin hydrochlorid - opioid-relaterede lidelser - andre narkotika stoffer - sixmo er angivet til substitutionsbehandling for opioidafhængighed i klinisk stabile voksne patienter, der kræver mere end 8 mg/dag af sublingual buprenorphin, inden for en ramme af medicinsk, social og psykologisk behandling.

União Europeia - dinamarquês - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - bryst neoplasmer - antineoplastiske midler - 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.

União Europeia - dinamarquês - EMA (European Medicines Agency)

sanofi b.v. - sutimlimab - hemolysis; anemia, hemolytic, autoimmune - immunosuppressiva - enjaymo is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (cad).

União Europeia - dinamarquês - EMA (European Medicines Agency)

neuraxpharm pharmaceuticals s.l. - ublituximab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppressiva - briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features.

União Europeia - dinamarquês - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosuppressiva - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

União Europeia - dinamarquês - EMA (European Medicines Agency)

insmed netherlands b.v. - amikacin sulfate - luftvejsinfektioner - antibakterielle midler til systemisk brug, - arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (ntm) lung infections caused by mycobacterium avium complex (mac) in adults with limited treatment options who do not have cystic fibrosis.

Dinamarca - dinamarquês - Lægemiddelstyrelsen (Danish Medicines Agency)

sandoz gmbh - carvedilol - tabletter - 25 mg

União Europeia - dinamarquês - EMA (European Medicines Agency)

blue earth diagnostics ireland ltd - fluciclovine (18f) - prostatic neoplasms; radionuclide imaging - diagnostiske radioaktive lægemidler - dette lægemiddel er kun til diagnostisk brug. axumin er angivet for positron-emissions-tomografi (pet) - billedbehandling til at opdage tilbagefald af kræft i prostata hos voksne mænd med en mistanke om recidiv baseret på forhøjet prostata specifikt antigen (psa) - niveauer efter primær kurativ behandling.

Dinamarca - dinamarquês - Lægemiddelstyrelsen (Danish Medicines Agency)

boehringer ingelheim int. gmbh - tiotropiumbromidmonohydrat - inhalationsvæske, opløsning - 2,5 mikrogram

Dinamarca - dinamarquês - Lægemiddelstyrelsen (Danish Medicines Agency)

orifarm a/s - tiotropium bromid - inhalationsvæske, opløsning - 2,5 mikrogram