Den Europæiske Union - dansk - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastiske midler - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pfizer europe ma eeig - bosutinib (som monohydrat) - leukæmi, myeloid - antineoplastic agents, protein kinase inhibitors - bosulif er indiceret til behandling af voksne patienter med nyligt diagnosticeret kronisk fase (cp) philadelphia-kromosom-positiv kronisk myelogenous leukæmi (ph+ cml). cp, accelereret fase (ap), og blast fase (bp) ph+ cml, der tidligere er behandlet med en eller flere tyrosin kinase inhibitor(s) [tki(s)], og for hvem imatinib, nilotinib og dasatinib er ikke anset som egnede behandlingsmuligheder.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. se afsnit 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pharmsure veterinary products europe ltd - mycoplasma synoviae stamme ms-h - immunologicals for aves, live bakterielle vacciner - kylling - til aktiv immunisering af fremtidige slagtekyllinger, kyllinger fra fremtidige lagdeltagere og fremtidige lagkyllinger for at reducere lungerne og reducere antallet af æg med unormal skaldannelse forårsaget af mycoplasma synoviae.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

ceva santé animale - cabergolin - prolactine-hæmmere, genito urinary system and sex hormones, andre gynecologicals - til brug i besætningen management program af malkekøer som en støtte i den bratte tørring-off ved at reducere produktionen af mælk, at:reducere mælk lækage ved goldning;reducere risikoen for nye intramammary infektioner i den tørre periode, for at reducere ubehag.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

b. braun melsungen - acetylcystein, alanin, arginin, asparaginsyre, glutaminsyre, glycin, histidin, isoleucin, leucin, lysinmonohydrat, methionin, n-acetyltyrosin, phenylalanin, prolin, serin, taurin, threonin, tryptophan, valin - infusionsvæske, opløsning

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

fresenius kabi ab - alanin, arginin, asparaginsyre, glutaminsyre, glycyl-l-glutamin hydrate, glycyltyrosindihydrat, histidin, isoleucin, leucin, lysinacetat, methionin, phenylalanin, prolin, serin, threonin, tryptophan, valin - infusionsvæske, opløsning

Den Europæiske Union - dansk - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - forløbercellelimfoblastisk leukæmi-lymfom - antineoplastiske midler - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

aspen pharma trading ltd. - levothyroxinnatrium - tabletter - 100 mikrogram

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

orifarm a/s - levothyroxinnatrium - tabletter - 100 mikrogram