Sverige - svenska - Läkemedelsverket (Medical Products Agency)

pharmaswiss ceska republika s.r.o. - pemetrexeddinatrium (vattenfri) - pulver till koncentrat till infusionsvätska, lösning - 100 mg - pemetrexeddinatrium (vattenfri) 110,3 mg aktiv substans; mannitol hjälpämne

Europeiska unionen - svenska - EMA (European Medicines Agency)

roche registration gmbh - atezolizumab - carcinoma, transitional cell; carcinoma, non-small-cell lung; urologic neoplasms; breast neoplasms; small cell lung carcinoma - antineoplastiska medel - 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 som monoterapi är indicerat för behandling av vuxna patienter med lokalt avancerad eller metastaserad icke-småcellig lungcancer efter tidigare kemoterapi. 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 som monoterapi är indicerat för behandling av vuxna patienter med lokalt avancerad eller metastaserad icke-småcellig lungcancer efter tidigare kemoterapi. 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.

Europeiska unionen - svenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - trastuzumab - breast neoplasms; stomach neoplasms - antineoplastiska medel - breast cancermetastatic breast cancer zercepac is indicated for the treatment of adult patients with her2 positive metastatic breast cancer (mbc):as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. tidigare kemoterapi måste ha inkluderat åtminstone ett anthracycline och en taxane om patienter som är olämpliga för dessa behandlingar. hormon receptor-positiva patienter måste också ha misslyckats med hormonell behandling, om inte patienter som är olämpliga för dessa behandlingar.                      in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. i kombination med docetaxel för behandling av de patienter som inte fått kemoterapi mot sin metastatiska sjukdom. i kombination med en aromatashämmare för behandling av postmenopausala patienter med hormonreceptorpositiv mbc, inte tidigare behandlats med trastuzumab. early breast cancer zercepac is indicated for the treatment of adult patients with her2 positive early breast cancer (ebc). efter kirurgi, kemoterapi (neoadjuvant eller adjuvant) och strålbehandling (om tillämpbart). efter adjuvant kemoterapi med doxorubicin och cyklofosfamid, i kombination med paklitaxel eller docetaxel. i kombination med adjuvant kemoterapi som utgörs av docetaxel och karboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either her2 overexpression or her2 gene amplification as determined by an accurate and validated assay. metastatic gastric cancer zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with her2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. zercepac should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. korrekt och validerat analysen metoder som ska användas.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

acucort ab - dexametason - munsönderfallande film - 6 mg - glycerol hjälpämne; dexametason 6 mg aktiv substans

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

acucort ab - dexametason - munsönderfallande film - 4 mg - dexametason 4 mg aktiv substans; glycerol hjälpämne

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

acucort ab - dexametason - munsönderfallande film - 8 mg - dexametason 8 mg aktiv substans; glycerol hjälpämne

Europeiska unionen - svenska - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - trastuzumab deruxtecan - bröst-neoplasmer - antineoplastiska medel - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

iba pharma s.a. - fludeoxiglukos(f-18) - injektionsvätska, lösning - 185 mbq/ml - fludeoxiglukos(f-18) 185 mbq aktiv substans - fludeoxiglukos(f-18)

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

theramex ireland limited - risedronatnatrium - filmdragerad tablett - 35 mg - risedronatnatrium 35 mg aktiv substans; laktosmonohydrat hjälpämne - risedronsyra

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

theramex ireland limited - risedronatnatrium - filmdragerad tablett - 5 mg - risedronatnatrium 5 mg aktiv substans; laktosmonohydrat hjälpämne - risedronsyra