Canada - English - Health Canada

astrazeneca canada inc - durvalumab - solution - 50mg - durvalumab 50mg - antineoplastic agents

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - durvalumab 120mg;   - concentrate for infusion - active: durvalumab 120mg   excipient: histidine histidine hydrochloride monohydrate polysorbate 80 trehalose dihydrate water for injection - imfinzi (durvalumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: · have disease progression during or following platinum-containing chemotherapy · have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy this indication is approved based on objective response rate and duration of response in a single arm study. an improvement in survival or disease-related symptoms has not been established.

New Zealand - English - Medsafe (Medicines Safety Authority)

astrazeneca limited - durvalumab 500mg;   - concentrate for infusion - active: durvalumab 500mg   excipient: histidine histidine hydrochloride monohydrate polysorbate 80 trehalose dihydrate water for injection - imfinzi (durvalumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: · have disease progression during or following platinum-containing chemotherapy · have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy this indication is approved based on objective response rate and duration of response in a single arm study. an improvement in survival or disease-related symptoms has not been established.

Israel - English - Ministry of Health

astrazeneca (israel) ltd - durvalumab - solution for infusion - durvalumab 50 mg/ml - durvalumab - urothelial carcinoma imfinzi is indicated for the treatment of patients with pd-l1 high (tumor cell ≥25% or ic ≥25%) locally advanced or metastatic urothelial carcinoma who: - have disease progression during or following platinum-containing chemotherapy. - have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum containing chemotherapy. non-small cell lung cancer - imfinzi is indicated for the treatment of patients with unresectable stage iii non-small cell lung cancer (nsclc) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.- imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations.small cell lung cancer imfinzi, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (es-sclc).biliary tract cancersimfinzi in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (btc).hepatocellular carcinomaimfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Singapore - English - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - durvalumab - infusion, solution concentrate - durvalumab 50 mg/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

agepha pharma s.r.o. - aciclovir - eye ointment - 30 milligram(s)/gram - aciclovir

Australia - English - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - durvalumab, quantity: 500 mg - injection, concentrated - excipient ingredients: histidine hydrochloride monohydrate; trehalose dihydrate; water for injections; polysorbate 80; histidine - locally advanced non-small cell lung cancer (nsclc),imfinzi is indicated for the treatment of patients with locally advanced, unresectable nsclc whose disease has not progressed following platinum-based chemoradiation therapy.,small cell lung cancer (sclc),imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,biliary tract cancer (btc),imfinzi in combination with gemcitabine and cisplatin is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (btc).,hepatocellular carcinoma (hcc),imfinzi in combination with tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uhcc) who have not received prior treatment with a pd-1/pd-l1 inhibitor. malignant pleural mesothelioma (mpm),imfinzi in combination with pemetrexed and either cisplatin or carboplatin has provisional approval for the first-line treatment of patients with unresectable mpm with epithelioid histology.,the decision to approve this indication has been made on the basis of two phase 2 single arm studies. continued approval of this indication depends on verification and description of clinical benefit in a confirmatory trial.

Australia - English - Department of Health (Therapeutic Goods Administration)

astrazeneca pty ltd - durvalumab, quantity: 120 mg - injection, concentrated - excipient ingredients: histidine; water for injections; trehalose dihydrate; histidine hydrochloride monohydrate; polysorbate 80 - locally advanced non-small cell lung cancer (nsclc),imfinzi is indicated for the treatment of patients with locally advanced, unresectable nsclc whose disease has not progressed following platinum-based chemoradiation therapy.,small cell lung cancer (sclc),imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (es-sclc).,biliary tract cancer (btc),imfinzi in combination with gemcitabine and cisplatin is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer (btc).,hepatocellular carcinoma (hcc),imfinzi in combination with tremelimumab is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uhcc) who have not received prior treatment with a pd-1/pd-l1 inhibitor. malignant pleural mesothelioma (mpm),imfinzi in combination with pemetrexed and either cisplatin or carboplatin has provisional approval for the first-line treatment of patients with unresectable mpm with epithelioid histology.,the decision to approve this indication has been made on the basis of two phase 2 single arm studies. continued approval of this indication depends on verification and description of clinical benefit in a confirmatory trial.