Europeiska unionen - svenska - EMA (European Medicines Agency)

takeda gmbh - pantoprazol - gastroesofageal reflux - proton pump hämmare - kortvarig behandling av reflux symptom (t.ex.. halsbränna, sur regurgitation) hos vuxna.

Europeiska unionen - svenska - EMA (European Medicines Agency)

roche registration gmbh - vemurafenib - melanom - antineoplastiska medel - vemurafenib är indicerat som monoterapi för behandling av vuxna patienter med braf-v600-mutationspositivt oreceptabelt eller metastatiskt melanom.

Europeiska unionen - svenska - EMA (European Medicines Agency)

takeda gmbh - pantoprazol - gastroesofageal reflux - proton pump hämmare - kortvarig behandling av reflux symptom (t.ex.. halsbränna, sur regurgitation) hos vuxna.

Europeiska unionen - svenska - EMA (European Medicines Agency)

abbvie deutschland gmbh & co. kg - dalbavancin hydrochloride - soft tissue infections; skin diseases, bacterial - antibakteriella medel för systemiskt bruk, - behandling av akuta bakteriella hud- och mjukdelsinfektioner (absssi) hos vuxna.

Europeiska unionen - svenska - EMA (European Medicines Agency)

takeda gmbh - pantoprazol - gastroesofageal reflux - proton pump hämmare - kortvarig behandling av reflux symptom (t.ex.. halsbränna, sur regurgitation) hos vuxna.

Europeiska unionen - svenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumab - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastiska medel - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. relative to nivolumab monotherapy, an increase in progression-free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression (see sections 4. 4 och 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%.

Europeiska unionen - svenska - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - nintedanib - carcinom, non-small cell lung - antineoplastiska medel - vargatef är indicerat i kombination med docetaxel för behandling av vuxna patienter med lokalt avancerad, metastaserande eller lokalt recidiverande icke-småcellig lungcancer (nsclc) av tumör adenokarcinomhistologi efter första kemoterapi.

Europeiska unionen - svenska - EMA (European Medicines Agency)

ptc therapeutics international limited - ataluren - muskeldystrofi, duchenne - andra droger för sjukdomar i muskel-skelettsystemet - translarna är indicerat för behandling av duchennes muskeldystrofi följd av nonsens mutation i dystrofin-genen, i ambulerande patienter i åldern 2 år och äldre. effekt har inte påvisats i icke-ambulerande patienter. förekomsten av nonsens mutation i dystrofin gen ska vara bestäms av genetiska tester.

Europeiska unionen - svenska - EMA (European Medicines Agency)

sanofi b.v. - tyrotropin alfa - sköldkörtelnoplasmer - främre hypofys lob hormoner och analoger, hypofysen och hypotalamus hormoner och derivat - thyrogen is indicated for use with serum thyroglobulin (tg) testing with or without radioiodine imaging for the detection of thyroid remnants and well-differentiated thyroid cancer in post thyroidectomy patients maintained on hormone suppression therapy (thst). low risk patients with well-differentiated thyroid carcinoma who have undetectable serum tg levels on thst and no rh (recombinant human) tsh-stimulated increase of tg levels may be followed-up by assaying rh tsh-stimulated tg levels. thyrogen is indicated for pre-therapeutic stimulation in combination with a range of 30 mci (1. 1 gbq) to 100 mci (3. 7 gbq) radioiodine for ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer (see section 4.

Europeiska unionen - svenska - EMA (European Medicines Agency)

roche registration gmbh - alectinibhydroklorid - carcinom, non-small cell lung - antineoplastiska medel - alecensa som monoterapi är indicerad för förstahandsbehandling av vuxna patienter med anaplastisk lymfomkinas (alk) -positiv avancerad icke-småcellig lungcancer (nsclc). alecensa som monoterapi är indicerat för behandling av vuxna patienter med alk‑positiv avancerad icke småcellig lungcancer som tidigare har behandlats med crizotinib.