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

amcla pty ltd -

Unione Europea - inglese - EMA (European Medicines Agency)

janssen-cilag international n.v.    - amivantamab - carcinoma, non-small-cell lung - antineoplastic agents - rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Israele - inglese - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 100 mg - abemaciclib - verzenio™ (abemaciclib) is indicated:•in combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer.•in combination with fulvestrant for the treatment of women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.•as monotherapy for the treatment of adult patients with hr-positive, her2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (cdk4 and cdk6) inhibitor.• verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence.in pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.

Israele - inglese - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 150 mg - abemaciclib - verzenio™ (abemaciclib) is indicated:•in combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer.•in combination with fulvestrant for the treatment of women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.•as monotherapy for the treatment of adult patients with hr-positive, her2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (cdk4 and cdk6) inhibitor..• verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence.in pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.

Israele - inglese - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 200 mg - abemaciclib - verzenio™ (abemaciclib) is indicated:•in combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer.•in combination with fulvestrant for the treatment of women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.•as monotherapy for the treatment of adult patients with hr-positive, her2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (cdk4 and cdk6) inhibitor.• verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence.in pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.

Israele - inglese - Ministry of Health

eli lilly israel ltd, israel - abemaciclib - film coated tablets - abemaciclib 50 mg - abemaciclib - verzenio™ (abemaciclib) is indicated:•in combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer.•in combination with fulvestrant for the treatment of women with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.•as monotherapy for the treatment of adult patients with hr-positive, her2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (cdk4 and cdk6) inhibitor.• verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence.in pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.

Israele - inglese - Ministry of Health

astrazeneca (israel) ltd - osimertinib as mesylate - tablets - osimertinib as mesylate 40 mg - osimertinib - tagrisso as monotherapy is indicated for: • the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) mutations. • the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclc. tagrisso is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 l858r mutations.

Israele - inglese - Ministry of Health

astrazeneca (israel) ltd - osimertinib as mesylate - tablets - osimertinib as mesylate 80 mg - osimertinib - tagrisso as monotherapy is indicated for: • the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating epidermal growth factor receptor (egfr) mutations. • the treatment of adult patients with locally advanced or metastatic egfr t790m mutation-positive nsclctagrisso is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 l858r mutations.

Israele - inglese - Ministry of Health

novartis israel ltd - ribociclib as succinate - film coated tablets - ribociclib as succinate 200 mg - ribociclib - kisqali is indicated in combination with:* a non-steroid aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women, with hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer, as initial endocrine-based therapy.or* fulvestrant for the treatment of men and postmenopausal women with hr-positive, her2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

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

eli lilly australia pty ltd - abemaciclib, quantity: 50 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; macrogol 3350; iron oxide yellow; iron oxide red; polyvinyl alcohol; sodium stearylfumarate; lactose monohydrate; purified talc; microcrystalline cellulose; silicon dioxide; titanium dioxide - early breast cancer verzenio in combination with endocrine therapy is indicated for the adjuvant treatment of patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node-positive early breast cancer at high risk of recurrence.,in pre- or peri-menopausal women, endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.,advanced or metastatic breast cancer verzenio is indicated for the treatment of hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or following prior endocrine therapy.,in pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist.