Uniunea Europeană - suedeză - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastiska medel - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. patienter med egfr eller alk-positiv tumör mutationer bör också ha fått riktad terapi innan du tar emot keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Uniunea Europeană - suedeză - 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.

Uniunea Europeană - suedeză - EMA (European Medicines Agency)

neovii biotech gmbh - catumaxomab - ascites; cancer - andra antineoplastiska medel - removab är indicerat för intraperitoneal behandling av maligna ascites hos patienter med epcam-positiva karcinomer där standardbehandling inte är tillgänglig eller inte längre möjlig.

Suedia - suedeză - Läkemedelsverket (Medical Products Agency)

ebb medical ab - rifampicin - pulver och vätska till infusionsvätska, lösning - 600 mg - rifampicin 600 mg aktiv substans

Uniunea Europeană - suedeză - EMA (European Medicines Agency)

krka, d.d., novo mesto - atazanavir (as sulfate) - hiv-infektioner - antivirala medel för systemisk användning - atazanavir krka kapslar, samförvaltas med låg dos ritonavir, är indicerat för behandling av hiv-1 infekterade vuxna och pediatriska patienter 6 år och äldre i kombination med andra antiretrovirala läkemedel. baserat på tillgängliga virologiska och kliniska data från vuxna patienter, ingen nytta förväntas hos patienter med virusstammar som är resistenta mot flera proteashämmare (≥ 4 pi mutationer). valet av atazanavir krka i behandling erfarna vuxna och pediatriska patienter skall baseras på individuella viral resistens testning och patientens behandling historia.

Suedia - suedeză - Läkemedelsverket (Medical Products Agency)

abboxia ab - rifampicin - pulver och vätska till infusionsvätska, lösning - 600 mg - rifampicin 600 mg aktiv substans

Suedia - suedeză - Läkemedelsverket (Medical Products Agency)

teva b.v. - mikafunginnatrium - pulver till koncentrat till infusionsvätska, lösning - 100 mg - sackaros hjälpämne; mikafunginnatrium 101,73 mg aktiv substans

Suedia - suedeză - Läkemedelsverket (Medical Products Agency)

mylan ab - mikafunginnatrium - pulver till koncentrat till infusionsvätska, lösning - 50 mg - mikafunginnatrium 50,86 mg aktiv substans; laktosmonohydrat hjälpämne

Suedia - suedeză - Läkemedelsverket (Medical Products Agency)

mylan ab - mikafunginnatrium - pulver till koncentrat till infusionsvätska, lösning - 100 mg - mikafunginnatrium 101,73 mg aktiv substans; laktosmonohydrat hjälpämne

Suedia - suedeză - Läkemedelsverket (Medical Products Agency)

bioglan ab - mikafunginnatrium - pulver till koncentrat till infusionsvätska, lösning - 50 mg - laktosmonohydrat hjälpämne; mikafunginnatrium 50,86 mg aktiv substans