Unjoni Ewropea - Norveġiż - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - teduglutide - malabsorptionssyndrom - andre alimentary tract and metabolism products, - revestiv er indisert for behandling av pasienter i alderen 1 år og over med korttarmsyndrom (sbs). pasienter bør være stabile etter en periode med tarmtilpasning etter operasjon. revestive er indisert for behandling av pasienter i alderen 1 år og over med kort tarm syndrom. pasienter bør være stabile etter en periode med tarmtilpasning etter operasjon.

Unjoni Ewropea - Norveġiż - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - hydrokortison - binyreinsuffisiens - kortikosteroider for systemisk bruk - behandling av adrenal insuffisiens hos voksne.

Unjoni Ewropea - Norveġiż - EMA (European Medicines Agency)

glaxosmithkline trading services limited - flutikason furoate, umeclidinium bromide, vilanterol trifenatate - lungesykdom, kronisk obstruktiv - legemidler for obstruktive sykdommer i luftveiene, - elebrato ellipta er angitt som en behandling i voksen pasienter med moderat til alvorlig kroniske hindrende lunge sykdom (copd) som ikke behandles tilstrekkelig med en kombinasjon av en inhalert kortikosteroid og en langtidsvirkende β2-agonistiske.

Unjoni Ewropea - Norveġiż - EMA (European Medicines Agency)

takeda pharmaceuticals international ag ireland branch - lanadelumab - angioødemer, arvelig - other hematological agents - takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in patients aged 2 years and older.

Unjoni Ewropea - Norveġiż - EMA (European Medicines Agency)

glaxosmithkline trading services limited - zanamivir - influensa, human - antivirale midler til systemisk bruk - dectova er angitt for behandling av kompliserte og potensielt livstruende influensa a eller b virus infeksjon hos voksne og paediatric pasienter (i alderen ≥6 måneder) når:pasientens influensa-viruset er kjent eller mistenkt for å være motstandsdyktig mot anti-influensa legemidler andre enn zanamivir, og/orother anti-viral legemidler for behandling av influensa, inkludert inhalert zanamivir, er ikke egnet for den enkelte pasient. dectova bør brukes i samsvar med offisielle veiledning.

Unjoni Ewropea - Norveġiż - EMA (European Medicines Agency)

glaxosmithkline trading services limited - flutikason furoate, umeclidinium bromide, vilanterol trifenatate - lungesykdom, kronisk obstruktiv - legemidler for obstruktive sykdommer i luftveiene, - temybric ellipta er angitt som en vedlikeholdsbehandling hos voksne pasienter med moderat til alvorlig kronisk obstruktiv lungesykdom (kols) som ikke er tilstrekkelig behandlet med en kombinasjon av en inhalert kortikosteroid og en langtidsvirkende β2-agonist eller en kombinasjon av langtidsvirkende β2-agonist og en langtidsvirkende muskarine antagonist (for effekter på symptom kontroll og forebygging av eksaserbasjoner se punkt 5..

Unjoni Ewropea - Norveġiż - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - belantamab mafodotin - multippelt myelom - antineoplastiske midler - blenrep is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-cd38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Unjoni Ewropea - Norveġiż - EMA (European Medicines Agency)

mylan ireland limited - abirateronacetat - prostata neoplasmer - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Unjoni Ewropea - Norveġiż - EMA (European Medicines Agency)

mylan ireland limited - rivaroksaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antithrombotic agents - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Unjoni Ewropea - Norveġiż - EMA (European Medicines Agency)

mylan ireland limited - dimetylfumarat - multippel sklerose, relapsing-remitting - immunsuppressive - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.