Kesatuan Eropah - Iceland - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - Æxlishemjandi lyf - urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or - who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancer tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous non small cell lung cancer (nsclc). in patients with egfr mutant or alk-positive nsclc, tecentriq, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies (see section 5. tecentriq, in combination with nab paclitaxel and carboplatin, is indicated for the first line treatment of adult patients with metastatic non-squamous nsclc who do not have egfr mutant or alk positive nsclc (see section 5. tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq eitt og sér er ætlað fyrir meðferð fullorðinn sjúklinga með staðnum háþróaður eða sjúklingum nsclc eftir áður en lyfjameðferð. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. small cell lung cancertecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc) (see section 5. hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (hcc) who have not received prior systemic therapy (see section 5. urothelial carcinomatecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (uc):- after prior platinum containing chemotherapy, or- who are considered cisplatin ineligible, and whose tumours have a pd-l1 expression ≥ 5% (see section 5. non-small cell lung cancertecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumours have a pd-l1 expression ≥ 50% tumour cells (tc) or ≥ 10% tumour-infiltrating immune cells (ic) and who do not have egfr mutant or alk-positive nsclc (see section 5. tecentriq eitt og sér er ætlað fyrir meðferð fullorðinn sjúklinga með staðnum háþróaður eða sjúklingum nsclc eftir áður en lyfjameðferð. patients with egfr mutant or alk positive nsclc should also have received targeted therapies before receiving tecentriq (see section 5. triple-negative breast cancertecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumours have pd-l1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.

Kesatuan Eropah - Iceland - EMA (European Medicines Agency)

astrazeneca ab - tremelimumab - carcinoma, hepatocellular - Æxlishemjandi lyf - imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc). imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (nsclc) with no sensitising egfr mutations or alk positive mutations.

Kesatuan Eropah - Iceland - EMA (European Medicines Agency)

accord healthcare s.l.u. - sorafenib tosilate - carcinoma, hepatocellular; carcinoma, renal cell - Æxlishemjandi lyf - hepatocellular carcinomasorafenib accord is indicated for the treatment of hepatocellular carcinoma (see section 5. renal cell carcinomasorafenib accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Kesatuan Eropah - Iceland - EMA (European Medicines Agency)

gilead sciences ireland uc - bulevirtide acetate - hepatitis d, chronic - veirueyðandi lyf til almennrar notkunar - hepcludex is indicated for the treatment of chronic hepatitis delta virus (hdv) infection in plasma (or serum) hdv-rna positive adult patients with compensated liver disease.

Iceland - Iceland - LYFJASTOFNUN (Icelandic Medicines Agency)

actavis group ptc ehf. - enalaprilum maleat; hydrochlorothiazidum inn - tafla - 20 mg/12,5 mg

Iceland - Iceland - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen ehf. - enalaprilum maleat; hydrochlorothiazidum inn - tafla - 20 mg/12,5 mg

Iceland - Iceland - LYFJASTOFNUN (Icelandic Medicines Agency)

teva b.v.* - valsartanum inn; hydrochlorothiazidum inn - filmuhúðuð tafla - 160/12,5 mg

Iceland - Iceland - LYFJASTOFNUN (Icelandic Medicines Agency)

teva b.v.* - valsartanum inn; hydrochlorothiazidum inn - filmuhúðuð tafla - 80/12,5 mg

Iceland - Iceland - LYFJASTOFNUN (Icelandic Medicines Agency)

krka sverige ab - hydrochlorothiazide; valsartanum inn - filmuhúðuð tafla - 160 mg/12,5 mg

Iceland - Iceland - LYFJASTOFNUN (Icelandic Medicines Agency)

krka sverige ab - hydrochlorothiazide; valsartanum inn - filmuhúðuð tafla - 160 mg/25 mg