Vipdomet União Europeia - norueguês - EMA (European Medicines Agency)

vipdomet

takeda pharma a/s - alogliptin benzoate, metformin hydrochloride - diabetes mellitus, type 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus:as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin;in combination with pioglitazone (i. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone;in combination with insulin (i. triple kombinasjon terapi) som et tillegg til diett og trening for å bedre glykemisk kontroll hos pasienter når insulin på en stabil dose og metformin alene ikke gir tilstrekkelig glykemisk kontroll.

Vizamyl União Europeia - norueguês - EMA (European Medicines Agency)

vizamyl

ge healthcare as - flutemetamol (18f) - radionuclide imaging; alzheimer disease - diagnostiske radiopharmaceuticals - dette legemidlet er kun til diagnostisk bruk. vizamyl er en radiopharmaceutical legemiddel indikert for positron emisjon tomografi (pet) avbildningen av amyloid-β neuritic plakk tetthet i hjernen hos voksne pasienter med kognitiv svikt som blir vurdert for alzheimers sykdom (ad) og andre årsaker til kognitiv svikt. vizamyl bør brukes sammen med en klinisk vurdering. en negativ søk angir sparsom eller ingen plakk, som ikke er forenlig med diagnosen ad.

Tagrisso União Europeia - norueguês - EMA (European Medicines Agency)

tagrisso

astrazeneca ab - osimertinib mesilate - karsinom, ikke-småcellet lunge - andre cytostatika, protein kinase hemmere - tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations- the first-line treatment of adult patients nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso as monotherapy is indicated for:- the adjuvant treatment after complete tumour resection in adult patients with stage ib-iiia non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations. - the first-line treatment of adult patients with locally advanced or metastatic nsclc with activating egfr mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc.

Stelara União Europeia - norueguês - EMA (European Medicines Agency)

stelara

janssen-cilag international nv - ustekinumab - psoriasis; arthritis, psoriatic; crohn disease; colitis, ulcerative - immunsuppressive - crohns diseasestelara er indisert for behandling av voksne pasienter med moderat til alvorlig aktiv crohns sykdom som har hatt utilstrekkelig respons med, mistet svar på, eller var intolerant å enten konvensjonell terapi eller en tnfa antagonist eller har medisinske kontraindikasjoner for slike behandlinger. ulcerøs colitisstelara er indisert for behandling av voksne pasienter med moderat til alvorlig aktiv ulcerøs kolitt som har hatt utilstrekkelig respons med, mistet svar på, eller var intolerant å enten konvensjonell terapi eller en biologisk eller har medisinske kontraindikasjoner for slike behandlinger. plakk psoriasisstelara er angitt for behandling av moderat til alvorlig plakkpsoriasis hos voksne som ikke klarte å svare på, eller som har en kontraindikasjon mot eller er intolerante overfor andre systemiske behandlingsformer, inkludert ciclosporin, methotrexate og psoralen ultrafiolett a. paediatric plakk psoriasisstelara er angitt for behandling av moderat til alvorlig plakkpsoriasis hos barn og ungdom pasienter fra 6 år år og eldre, som ikke er tilstrekkelig kontrollert av, eller er intolerante til, andre systemiske behandlingsformer eller phototherapies. psoriasis arthritisstelara, alene eller i kombinasjon med metotreksat, er indisert for behandling av aktiv psoriasisartritt hos voksne pasienter når responsen på tidligere ikke-biologiske sykdomsmodifiserende antirevmatiske legemiddel (dmard) terapi har vært mangelfull.

Pegasys União Europeia - norueguês - 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 å innlede behandling i paediatric pasienter se kapittel 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 hepatitt c-virus (hcv) genotypen bestemt aktivitet, se kapittel 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 du bestemmer deg for å starte behandling i barndommen, er det viktig å vurdere vekst hemming indusert ved kombinasjonsbehandling. den reversibilitet av vekst hemming er usikker. beslutningen om å behandle bør gjøres på en sak til sak-basis (se kapittel 4.

Thalidomide BMS (previously Thalidomide Celgene) União Europeia - norueguês - EMA (European Medicines Agency)

thalidomide bms (previously thalidomide celgene)

bristol-myers squibb pharma eeig - thalidomid - multippelt myelom - immunsuppressive - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.

Pemetrexed Pfizer (previously Pemetrexed Hospira) União Europeia - norueguês - EMA (European Medicines Agency)

pemetrexed pfizer (previously pemetrexed hospira)

pfizer europe ma eeig - pemetrexed disodium, pemetrexed disodium hemipentahydrate - carcinoma, non-small-cell lung; mesothelioma - antineoplastiske midler - malignant pleural mesotheliomapemetrexed pfizer in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancerpemetrexed pfizer in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. pemetrexed pfizer is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. pemetrexed pfizer is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Orfadin União Europeia - norueguês - EMA (European Medicines Agency)

orfadin

swedish orphan biovitrum international ab - nitisinone - tyrosinemias - andre alimentary tract and metabolism products, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine. alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

Credelio União Europeia - norueguês - EMA (European Medicines Agency)

credelio

elanco gmbh - lotilaner - ectoparasiticides for systemisk bruk, isoxazolines - dogs; cats - for behandling av loppemarked og hake infestations. lopper og flått må feste til verten og påbegynne fôring for å bli utsatt for det aktive stoffet. veterinærpreparatet kan brukes som en del av en behandlingsstrategi for kontroll av loppeallergi dermatitt (fad). dogsthis veterinærpreparatet gir umiddelbar og vedvarende drepe aktivitet for 1 måned for lopper (ctenocephalides felis og c. canis) og flått (rhipicephalus sanguineus, ixodes ricinus, jeg. hexagonus og dermacentor reticulatus). catsthis veterinærpreparatet gir umiddelbar og vedvarende drepe aktivitet for 1 måned mot lopper (ctenocephalides felis og c. canis) og flått (ixodes ricinus).

Onglyza União Europeia - norueguês - EMA (European Medicines Agency)

onglyza

astrazeneca ab - saxagliptin - diabetes mellitus, type 2 - legemidler som brukes i diabetes - add-on combination therapyonglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.