Imbruvica Europäische Union - Dänisch - EMA (European Medicines Agency)

imbruvica

janssen-cilag international nv - ibrutinib - lymphoma, mantle-cell; leukemia, lymphocytic, chronic, b-cell - antineoplastic agents, protein kinase inhibitors - imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (mcl). imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with cll who have received at least one prior therapy. imbruvica as a single agent 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. imbruvica in combination with rituximab is indicated for the treatment of adult patients with wm.

Dasatinib Accordpharma Europäische Union - Dänisch - EMA (European Medicines Agency)

dasatinib accordpharma

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastiske midler - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Kerendia Europäische Union - Dänisch - EMA (European Medicines Agency)

kerendia

bayer ag - finerenone - renal insufficiency, chronic; diabetes mellitus, type 2 - agenter, der virker på renin-angiotensinsystemet - kerendia is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

Vafseo Europäische Union - Dänisch - EMA (European Medicines Agency)

vafseo

akebia europe limited - vadadustat - renal insufficiency, chronic; anemia - antianemiske præparater - vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (ckd) in adults on chronic maintenance dialysis.

Pegasys Europäische Union - Dänisch - EMA (European Medicines Agency)

pegasys

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4. 4 og 5. paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. med hensyn til beslutningen om at indlede behandling hos pædiatriske patienter, se afsnit 4. 2, 4. 4 og 5. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4. 2, 4. 4 og 5. for at hepatitis c virus (hcv) genotype specifik aktivitet, se afsnit 4. 2 og 5. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. når det besluttes at indlede behandling i barndommen, er det vigtigt at overveje, væksthæmning, der er fremkaldt af en kombination terapi. reversibilitet af væksthæmning er usikker. beslutningen om at behandling skal ske på grundlag af en individuel vurdering (se afsnit 4.

Numeta G16E infusionsvæske, emulsion Dänemark - Dänisch - Lægemiddelstyrelsen (Danish Medicines Agency)

numeta g16e infusionsvæske, emulsion

baxter a/s - alanin, arginin, asparaginsyre, calciumchloriddihydrat, cystein, glucosemonohydrat, glutaminsyre, glycin, histidin, isoleucin, kaliumacetat, leucin, lysinmonohydrat, magnesiumacetattetrahydrat, methionin, natriumchlorid, natriumglycerophosphat, hydreret, olivenolie, renset, ornithinmonohydrochlorid, phenylalanin, prolin, serin, soyaolie, renset, taurin, threonin, tryptophan, tyrosin, valin - infusionsvæske, emulsion

Numeta G19E infusionsvæske, emulsion Dänemark - Dänisch - Lægemiddelstyrelsen (Danish Medicines Agency)

numeta g19e infusionsvæske, emulsion

baxter a/s - alanin, arginin, asparaginsyre, calciumchloriddihydrat, cystein, glucosemonohydrat, glutaminsyre, glycin, histidin, isoleucin, kaliumacetat, leucin, lysinmonohydrat, magnesiumacetattetrahydrat, methionin, natriumchlorid, natriumglycerophosphat, hydreret, olivenolie, renset, ornithinmonohydrochlorid, phenylalanin, prolin, serin, soyaolie, renset, taurin, threonin, tryptophan, tyrosin, valin - infusionsvæske, emulsion

Finomel infusionsvæske, emulsion Dänemark - Dänisch - Lægemiddelstyrelsen (Danish Medicines Agency)

finomel infusionsvæske, emulsion

baxter a/s - alanin, arginin, calciumchloriddihydrat, fiskeolie, glucosemonohydrat, glycin, histidin, isoleucin, kaliumchlorid, leucin, lysinhydrochlorid, magnesiumsulfatheptahydrat, methionin, natriumacetattrihydrat, natriumglycerophosphat, hydreret, olivenolie, renset, phenylalanin, prolin, serin, soyaolie, threonin, triglycerider, middelkædelængde, tryptophan, tyrosin, valin, zinksulfat heptahydrat - infusionsvæske, emulsion

Finomel Perifer infusionsvæske, emulsion Dänemark - Dänisch - Lægemiddelstyrelsen (Danish Medicines Agency)

finomel perifer infusionsvæske, emulsion

baxter a/s - alanin, arginin, calciumchloriddihydrat, fiskeolie, glucosemonohydrat, glycin, histidin, isoleucin, kaliumchlorid, leucin, lysinhydrochlorid, magnesiumsulfatheptahydrat, methionin, natriumacetattrihydrat, natriumglycerophosphat, hydreret, olivenolie, renset, phenylalanin, prolin, serin, soyaolie, threonin, triglycerider, middelkædelængde, tryptophan, tyrosin, valin, zinksulfat heptahydrat - infusionsvæske, emulsion