Arab Saudi - Inggeris - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

roche - cobimetinib - film-coated tablet - 20 mg

Afrika Selatan - Inggeris - South African Health Products Regulatory Authority (SAHPRA)

roche products (pty) ltd - tablet - 20,0 mg - each tablet contains cobimetinib hemifumarate equivalent to cobimetinib 20,0 mg

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

genentech, inc. - atezolizumab (unii: 52cmi0wc3y) (atezolizumab - unii:52cmi0wc3y) - atezolizumab 1200 mg in 20 ml - - tecentriq, as a single-agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage ii to iiia [see clinical studies (14.1)] non-small cell lung cancer (nsclc) whose tumors have pd-l1 expression on ≥ 1% of tumor cells, as determined by an fda-approved test [see dosage and administration (2.1)]. - tecentriq, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have high pd-l1 expression (pd-l1 stained ≥ 50% of tumor cells [tc ≥ 50%] or pd-l1 stained tumor-infiltrating immune cells [ic] covering ≥ 10% of the tumor area [ic ≥ 10%]), as determined by an fda-approved test, with no egfr or alk genomic tumor aberrations [see dosage and administration (2.1)]. - tecentriq, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous nsclc with no egfr or alk genomic tumor abe

Israel - Inggeris - Ministry of Health

roche pharmaceuticals (israel) ltd - atezolizumab - concentrate for solution for infusion - atezolizumab 60 mg/ml - urothelial carcinoma• tecentriq (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours have a pd-l1 expression ≥ 5%.• tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.- non-small cell lung cancer •tecentriq, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have high pd-l1 expression (pd-l1 stained ≥ 50% of tumor cells [tc ≥ 50%] or pd-l1 stained tumor-infiltrating immune cells [ic] covering ≥ 10% of the tumor area [ic ≥ 10%]), as determined by an approved test, with no egfr or alk genomic tumor aberrations.•tecentriq, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous nsclc with no egfr or alk genomic tumor aberrations.• 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.• tecentriq is indicated for the treatment of patients with metastatic nsclc who are naïve to anti-pd-l1 or anti-pd-1 therapies and have disease progression during or following platinum-containing chemotherapy. patients with egfr or alk genomic tumor aberrations should have disease progression on approved therapy for nsclc harboring these aberrations prior to receiving tecentriq.• tecentriq as monotherapy, is indicated as adjuvant treatment following complete resection and no progression after platinum-based adjuvant chemotherapy for adult patients with stage ii to iiia nsclc whose tumors have pd-l1 expression on ≥ 50% of tumor cells (tcs).- locally advanced or metastatic triple-negative breast cancer tecentriq, in combination with nab-paclitaxel, is indicated for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (tnbc) whose tumors have pd-l1 expression ≥1% and who have not received prior chemotherapy for metastatic disease.- 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)."- hepatocellular carcinomatecentriq, in combination with bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (hcc) who have not received prior systemic therapy.- melanomatecentriq, in combination with cobimetinib and vemurafenib, is indicated for the treatment of patients with braf v600 mutation-positive unresectable or metastatic melanoma.- alveolar soft part sarcoma tecentriq, as a single agent, is indicated for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (asps).

Israel - Inggeris - Ministry of Health

roche pharmaceuticals (israel) ltd - atezolizumab - concentrate for solution for infusion - atezolizumab 60 mg / 1 ml - urothelial carcinoma• tecentriq (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours have a pd-l1 expression ≥ 5%.• tecentriq is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.- non-small cell lung cancer •tecentriq, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors have high pd-l1 expression (pd-l1 stained ≥ 50% of tumor cells [tc ≥ 50%] or pd-l1 stained tumor-infiltrating immune cells [ic] covering ≥ 10% of the tumor area [ic ≥ 10%]), as determined by an approved test, with no egfr or alk genomic tumor aberrations.•tecentriq, in combination with paclitaxel protein-bound and carboplatin,

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

viatris limited - itraconazole 100mg;   - capsule - 100 mg - active: itraconazole 100mg   excipient: capsugel red g60csa00150 colloidal silicon dioxide ethanol gelatin hypromellose iron oxide red methylene chloride opacode white s-1-7078 purified water sorbitan stearate sugar spheres titanium dioxide - itraconazole capsules are indicated for the treatment of: · vulvovaginal candidiasis. · pityriasis versicolor, · dermatomycosis - including highly keratinised regions as in plantar tinea pedis and palmer tinea manus, · fungal keratitis, · oral candidiasis, · onychomycosis caused by dermatophytes and/or yeasts. · systemic mycoses, only in the following fungal infections: - systemic aspergillosis - histoplasmosis, - histoplasmosis, maintenance therapy only in aids patients - sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous) - paraconccidioidomycosis, - chromomycosis, - blastomycosis

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - itraconazole 100mg;   - capsule - 100 mg - active: itraconazole 100mg   excipient: erythrosine gelatin   hypromellose indigo carmine macrogol 20000 sugar spheres titanium dioxide - sporanox capsules are indicated for the following conditions: - treatment of vulvovaginal candidiasis. - treatment of pityriasis versicolor. - treatment of dermatomycosis – including highly keratinised regions as in plantar tinea pedis and palmer tinea manus. - treatment of fungal keratitis. - treatment of oral candidiasis. - treatment of onychomycosis caused by dermatophytes and/or yeasts. - systemic mycoses, only in the following fungal infections: o treatment of systemic aspergillosis and candidiasis, o treatment of histoplasmosis, o histoplasmosis, maintenance therapy only in aids patients. o treatment of sporotrichosis (including lymphocutaneous/cutaneous and extracutaneous), o treatment of paracoccidioidomycosis, o treatment of chromomycosis, o treatment of blastomycosis.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - itraconazole 10 mg/ml - oral solution - 10 mg/ml - active: itraconazole 10 mg/ml excipient: caramel cherry flavour 654536 cherry flavour 654595 hydrochloric acid hydroxypropyl-beta-cyclodextrin propylene glycol purified water saccharin sodium sodium hydroxide sorbitol - sporanox oral solution is indicated for the: · treatment of oral and/or oesophageal candidiasis in hiv-positive or other immunocompromised patients. · prophylaxis of fungal infections in neutropenic patients.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - voriconazole 200mg;  ;   - film coated tablet - 200 mg - active: voriconazole 200mg     excipient: croscarmellose sodium lactose monohydrate magnesium stearate opadry white oy-ls-28914 povidone pregelatinised maize starch purified water   - vfend is indicated for treatment of the following fungal infections: · invasive aspergillosis. · serious candida sp. infections (including c. krusei), including oesophageal and systemic candida sp. infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). · serious fungal infections caused by scedosporium spp. and fusarium spp. · other serious fungal infections, in patients intolerant of, or refractory to, other therapy.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - voriconazole 50mg;  ;   - film coated tablet - 50 mg - active: voriconazole 50mg     excipient: croscarmellose sodium lactose monohydrate magnesium stearate opadry white oy-ls-28914 povidone pregelatinised maize starch purified water   - vfend is indicated for treatment of the following fungal infections: · invasive aspergillosis. · serious candida sp. infections (including c. krusei), including oesophageal and systemic candida sp. infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia). · serious fungal infections caused by scedosporium spp. and fusarium spp. · other serious fungal infections, in patients intolerant of, or refractory to, other therapy.