Európai Unió - svéd - EMA (European Medicines Agency)

pierre fabre medicament - neratinib - bröst-neoplasmer - antineoplastiska medel - nerlynx är indicerat för förlängd adjuvant behandling av vuxna patienter med tidigt skede hormon receptor positiva her2-överuttryckt/amplifierad bröstcancer och som är mindre än ett år efter slutförande av tidigare adjuvant trastuzumab baserad terapi.

Európai Unió - svéd - EMA (European Medicines Agency)

novartis europharm limited  - alpelisib - bröst-neoplasmer - antineoplastiska medel - piqray är indicerat i kombination med fulvestrant för behandling av postmenopausala kvinnor, och män, med hormon receptor (hr)-positiva, human epidermal growth factor receptor 2 (her2)-negativ, lokalt avancerad eller metastaserande bröstcancer med en pik3ca mutation efter att försämras i sin sjukdom efter endokrin terapi som monoterapi (se avsnitt 5.

Európai Unió - svéd - EMA (European Medicines Agency)

koanaa healthcare gmbh - imatinib mesilate - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma; gastrointestinal stromal tumors - antineoplastiska medel - imatinib koanaa is indicated for the treatment ofadult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. adult patients with relapsed or refractory ph+ all as monotherapy. adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. the effect of imatinib on the outcome of bone marrow transplantation has not been determined. imatinib koanaa is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patienter som har en låg eller mycket låg risk för återfall bör inte få adjuvant behandling. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. förutom vid nyligen diagnostiserad kml kronisk fas, det finns inga kontrollerade studier som visar på en klinisk nytta eller ökad överlevnad för dessa sjukdomar.

Európai Unió - svéd - EMA (European Medicines Agency)

argenx - efgartigimod alfa - myasthenia gravis - immunsuppressiva - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

Európai Unió - svéd - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunsuppressiva - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Svédország - svéd - Läkemedelsverket (Medical Products Agency)

amomed pharma gmbh - landiololhydroklorid - koncentrat till injektionsvätska, lösning - 10 mg/ml - etanol, vattenfri hjälpämne; landiololhydroklorid 10 mg aktiv substans; hydroxipropylbetadex hjälpämne

Svédország - svéd - Läkemedelsverket (Medical Products Agency)

b. braun melsungen ag - ondansetronhydrokloriddihydrat - injektionsvätska, lösning - 2 mg/ml - ondansetronhydrokloriddihydrat 2,5 mg aktiv substans - ondansetron

Svédország - svéd - Läkemedelsverket (Medical Products Agency)

septodont - adrenalintartrat; artikainhydroklorid - injektionsvätska, lösning - 40 mg/ml + 10 mikrogram/ml - adrenalintartrat 18,2 mikrog aktiv substans; artikainhydroklorid 40 mg aktiv substans; natriummetabisulfit hjälpämne - kombinationer

Svédország - svéd - Läkemedelsverket (Medical Products Agency)

septodont - adrenalintartrat; artikainhydroklorid - injektionsvätska, lösning - 40 mg/ml + 5 mikrogram/ml - natriummetabisulfit hjälpämne; adrenalintartrat 9,1 mikrog aktiv substans; artikainhydroklorid 40 mg aktiv substans - kombinationer

Svédország - svéd - Läkemedelsverket (Medical Products Agency)

orpha-devel handels und vertriebs gmbh - esmololhydroklorid - injektionsvätska, lösning - 10 mg/ml - esmololhydroklorid 10 mg aktiv substans - esmolol