Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

mirum pharmaceuticals international b.v. - maralixibat chloride - alagille syndrome - other drugs for bile therapy - livmarli is indicated for the treatment of cholestatic pruritus in patients with alagille syndrome (algs) 2 months of age and older.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

mylan pharmaceuticals limited - memantinhydroklorid - alzheimers sjukdom - other anti-dementia drugs, psychoanaleptics, - behandling av patienter med måttlig till svår alzheimers sjukdom.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

bluebird bio (netherlands) b.v. - autolog cd34+ cell berikad befolkningen som innehåller hematopoetiska stamceller transduced med lentiglobin bb305 lentiviral vektor kodning beta-en-t87q-globingenen - beta-talassemi - other hematological agents - zynteglo är indicerat för behandling av patienter som är 12 år och äldre med transfusion är beroende av β-thalassemi (tdt) som inte har en β0/β0 genotyp, för vem hematopoietiska stamceller (hsc) transplantation är lämpliga, men en human leukocyte antigen (hla-matchade relaterade hsc givare är inte tillgängligt.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

orion corporation - tasipimidine sulfate - other hypnotics and sedatives - hundar - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

agios netherlands b.v. - mitapivat sulfate - genetic diseases, inborn; anemia, hemolytic - other hematological agents - pyrukynd is indicated for the treatment of pyruvate kinase deficiency (pk deficiency) in adult patients (see section 4.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

accord healthcare s.l.u. - degarelix acetate - prostatiska neoplasmer - other hormone antagonists and related agents - degarelix accord is a gonadotrophin releasing hormone (gnrh) antagonist indicated:for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (som fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - antineoplastiska medel - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. polycytemi vera (pv)jakavi är indicerat för behandling av vuxna patienter med polycytemi vera som är resistenta eller intoleranta av hydroxyurea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

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.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

pfizer europe ma eeig  - axitinib - carcinom, njurcell - protein kinas-hämmare - inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc) after failure of prior treatment with sunitinib or a cytokine.

Kesatuan Eropah - Sweden - EMA (European Medicines Agency)

takeda pharma a/s - fentanylcitrat - pain; cancer - smärtstillande medel - instanyl är indicerat för hantering av genombrottssmärta hos vuxna som redan får underhållsuppioidbehandling för kronisk cancervärk. genombrottsmärta är en övergående förvärring av smärta som uppstår på grund av annars styrd, kvarhållen smärta.  patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.