Israel - Englisch - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 150 mg - olaparib - ovarian cancer:lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.first-line maintenance treatment of advanced ovarian cancer in combination with bevacizumablynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either:• a deleterious or suspected deleterious brca mutation, and/or• genomic instability breast cancer:germline brca-mutated her2-negative metastatic breast cancerlynparza is indicated in patients with deleterious or suspected deleterious gbrcam, her2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. patients with hormone receptor (hr)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.adjuvant treatment of germline brca-mutated her2-negative high risk early breast cancer lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gbrcam human epidermal growth factor receptor 2 (her2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. adenocarcinoma of the pancreas:first-line maintenance treatment of germline brca-mutated metastatic pancreatic adenocarcinomalynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.prostate cancer:• germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer (mcrpc) who have progressed following prior treatment with enzalutamide or abiraterone.• lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious hrr-mutated (hrrm) metastatic castration-resistant prostate cancer (mcrpc). select patients for therapy based on an approved companion diagnostic for lynparza

Israel - Englisch - Ministry of Health

astrazeneca (israel) ltd - olaparib - film coated tablets - olaparib 150 mg - olaparib - ovarian cancer:lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (figo stages iii and iv) brca1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.first-line maintenance treatment of advanced ovarian cancer in combination with bevacizumablynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (hrd) positive status defined by either:• a deleterious or suspected deleterious brca mutation, and/or• genomic instability breast cancer:germline brca-mutated her2-negative metastatic breast cancerlynparza is indicated in patients with deleterious or suspected deleterious gbrcam, her2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. patients with hormone receptor (hr)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.adjuvant treatment of germline brca-mutated her2-negative high risk early breast cancer lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gbrcam human epidermal growth factor receptor 2 (her2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. adenocarcinoma of the pancreas:first-line maintenance treatment of germline brca-mutated metastatic pancreatic adenocarcinomalynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.prostate cancer:germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancerlynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic brca1/2 or atm- mutated metastatic castration-resistant prostate cancer (mcrpc) who have progressed following prior treatment with enzalutamide or abiraterone.

Israel - Englisch - 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 - Englisch - 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.

Europäische Union - Englisch - EMA (European Medicines Agency)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - vaccines - active immunisation against h5 subtype of influenza a virus

Tschechische Republik - Tschechisch - SUKL (Státní ústav pro kontrolu léčiv)

g.l. pharma gmbh, lannach array - 13950 sertralin-hydrochlorid - potahovaná tableta - 100mg - sertralin

Tschechische Republik - Tschechisch - SUKL (Státní ústav pro kontrolu léčiv)

g.l. pharma gmbh, lannach array - 13950 sertralin-hydrochlorid - potahovaná tableta - 50mg - sertralin

Rumänien - Rumänisch - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

g.l. pharma ges.m.b.h. - austria - sertralinum - compr. film. - 50mg - antidepresive inhibitori selectivi ai recaptarii serotoninei

Rumänien - Rumänisch - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

g.l. pharma ges.m.b.h. - austria - sertralinum - compr. film. - 100mg - antidepresive inhibitori selectivi ai recaptarii serotoninei

Australien - Englisch - APVMA (Australian Pesticides and Veterinary Medicines Authority)

winfield solutions llc - methyl esters of canola oil fatty acids - emulsifiable concentrate - methyl esters of canola oil fatty acids ester active 780.0 g/l - adjuvant