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

astellas pharma australia pty ltd - enfortumab vedotin, quantity: 20 mg - injection, powder for - excipient ingredients: polysorbate 20; trehalose dihydrate; histidine; histidine hydrochloride monohydrate - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand-1 inhibitor.

Singapore - English - HSA (Health Sciences Authority)

astellas pharma singapore pte. ltd. - enfortumab vedotin - injection, powder, lyophilized, for solution - enfortumab vedotin 20.0 mg/vial

Singapore - English - HSA (Health Sciences Authority)

astellas pharma singapore pte. ltd. - enfortumab vedotin - injection, powder, lyophilized, for solution - enfortumab vedotin 30.0 mg/vial

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - ceftazidime pentahydrate 2 g - powder for injection - 2 g - active: ceftazidime pentahydrate 2 g excipient: sodium carbonate - treatment of single or multiple infections caused by susceptible organisms. may be used alone as first choice medicine before the results of sensitivity tests are available. may be used in combination with an aminoglycoside or most other ?- lactam antibiotics. may be used with an antibiotic against anaerobes when the presence of bacteroides fragilis is suspected.

New Zealand - English - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - ceftazidime pentahydrate 500mg - powder for injection - 500 mg - active: ceftazidime pentahydrate 500mg excipient: sodium carbonate - treatment of single or multiple infections caused by susceptible organisms. may be used alone as first choice medicine before the results of sensitivity tests are available. may be used in combination with an aminoglycoside or most other ?- lactam antibiotics. may be used with an antibiotic against anaerobes when the presence of bacteroides fragilis is suspected.

Israel - English - Ministry of Health

astellas pharma international b.v., israel - enfortumab vedotin - powder for concentrate for solution for infusion - enfortumab vedotin 20 mg/vial - enfortumab vedotin - padcev is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (muc) who: - have previously received a programmed death receptor-1 (pd-1) or programmed death-ligand 1 (pd-l1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting or:- are ineligible for cisplatin-containing chemotherapy and have previously received a pd-1/pd-l1 inhibitor.

Israel - English - Ministry of Health

astellas pharma international b.v., israel - enfortumab vedotin - powder for concentrate for solution for infusion - enfortumab vedotin 30 mg/vial - enfortumab vedotin - padcev is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (muc) who: - have previously received a programmed death receptor-1 (pd-1) or programmed death-ligand 1 (pd-l1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting or:- are ineligible for cisplatin-containing chemotherapy and have previously received a pd-1/pd-l1 inhibitor.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

glaxosmithkline uk ltd - ceftazidime pentahydrate - powder for solution for injection - 2gram

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

aspen pharmacare australia pty ltd - ceftazidime -

European Union - English - EMA (European Medicines Agency)

astellas pharma europe b.v. - enfortumab vedotin - carcinoma, transitional cell; urologic neoplasms - antineoplastic agents - padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.