Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

astrazeneca limited - exenatide 2mg;  ;   - injection with diluent - 2 mg - active: exenatide 2mg     excipient: 5050 dl 4ap polymer (poly(d,l-lactide-co-glycolide)) sucrose carmellose sodium dibasic sodium phosphate heptahydrate monobasic sodium phosphate monohydrate polysorbate 20 sodium chloride water for injection carmellose sodium dibasic sodium phosphate heptahydrate monobasic sodium phosphate monohydrate polysorbate 20 sodium chloride sodium hydroxide water for injection - bydureon is indicated for treatment of type 2 diabetes mellitus in combination with · metformin · sulphonylurea · thiazolidinedione · metformin and sulphonylurea · metformin and thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

astrazeneca limited - osimertinib mesilate 47.7mg equivalent to osimertinib 40mg;   - film coated tablet - 40 mg - active: osimertinib mesilate 47.7mg equivalent to osimertinib 40mg   excipient: hyprolose iron oxide black iron oxide red iron oxide yellow macrogol 3350 mannitol microcrystalline cellulose polyvinyl alcohol purified talc sodium stearyl fumarate titanium dioxide - tagrisso (osimertinib) as monotherapy is indicated for: - the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive non-small cell lung cancer. - the adjuvant treatment after tumour resection in adult patients with non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) mutations. tagrisso (osimertinib) is indicated in combination with: - pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic nsclc whose tumours have egfr mutations

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

astrazeneca limited - osimertinib mesilate 95.4mg equivalent to osimertinib 80 mg;   - film coated tablet - 80 mg - active: osimertinib mesilate 95.4mg equivalent to osimertinib 80 mg   excipient: hyprolose iron oxide black iron oxide red iron oxide yellow macrogol 3350 mannitol microcrystalline cellulose polyvinyl alcohol purified talc sodium stearyl fumarate titanium dioxide - tagrisso (osimertinib) as monotherapy is indicated for: - the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) mutations. - the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive non-small cell lung cancer. - the adjuvant treatment after tumour resection in adult patients with non-small cell lung cancer (nsclc) whose tumours have epidermal growth factor receptor (egfr) mutations. tagrisso (osimertinib) is indicated in combination with: - pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic nsclc whose tumours have egfr mutations

Noua Zeelandă - engleză - 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.

Noua Zeelandă - engleză - 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.

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

astrazeneca limited - anastrozole 1mg;   - film coated tablet - 1 mg - active: anastrozole 1mg   excipient: hypromellose lactose monohydrate macrogol 300 magnesium stearate povidone sodium starch glycolate titanium dioxide

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

astrazeneca limited - bicalutamide 50mg;   - film coated tablet - 50 mg - active: bicalutamide 50mg   excipient: hypromellose lactose monohydrate macrogol 300 magnesium stearate povidone sodium starch glycolate titanium dioxide

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

astrazeneca limited - formoterol fumarate 12ug;   - powder for inhalation - 12 mcg/dose - active: formoterol fumarate 12ug   excipient: lactose monohydrate

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

astrazeneca limited - formoterol fumarate 4.5ug (/dose for the m3 device. equivalent to 6 µg/dose of the m2 device.);   - powder for inhalation - 6 mcg/dose - active: formoterol fumarate 4.5ug (/dose for the m3 device. equivalent to 6 µg/dose of the m2 device.)   excipient: lactose monohydrate - oxis turbuhaler is indicated as add on therapy to maintenance treatment with inhaled corticosteroids for the treatment of broncho-obstructive symptoms and prevention of exercise-induced symptoms in adults and children six years of age and over with asthma when adequate treatment with corticosteroids is not sufficient. oxis turbuhaler should not be used in the treatment of acute asthmatic symptoms or in patients whose asthma can be managed by occasional use of short-acting beta-2 agonists.

Noua Zeelandă - engleză - Medsafe (Medicines Safety Authority)

astrazeneca limited - budesonide 100ug;  ;  ;   - powder for inhalation - 100 mcg/dose - active: budesonide 100ug       - bronchial asthma requiring maintenance treatment with glucocorticosteroids for control of the underlying airways inflammation.