Izrael - angličtina - Ministry of Health

neopharm ltd, israel - rucaparib as camsylate - film coated tablets - rucaparib as camsylate 250 mg - rucaparib - for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube,or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

Izrael - angličtina - Ministry of Health

neopharm ltd, israel - rucaparib as camsylate - film coated tablets - rucaparib as camsylate 300 mg - rucaparib - for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube,or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - talazoparib tosilate, quantity: 1.453 mg - capsule, hard - excipient ingredients: iron oxide red; hypromellose; silicified microcrystalline cellulose; iron oxide yellow; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - talzenna is indicated for the treatment of patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (brca) mutation according to a validated diagnostic test, who have human epidermal growth factor receptor 2 (her2)-negative, locally advanced or metastatic breast cancer.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - talazoparib tosilate, quantity: 1.453 mg - capsule, hard - excipient ingredients: silicified microcrystalline cellulose; iron oxide yellow; hypromellose; titanium dioxide; iron oxide red; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - talzenna is indicated for the treatment of patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (brca) mutation according to a validated diagnostic test, who have human epidermal growth factor receptor 2 (her2)-negative, locally advanced or metastatic breast cancer.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - talazoparib tosilate, quantity: 0.363 mg - capsule, hard - excipient ingredients: iron oxide yellow; silicified microcrystalline cellulose; hypromellose; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - talzenna is indicated for the treatment of patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (brca) mutation according to a validated diagnostic test, who have human epidermal growth factor receptor 2 (her2)-negative, locally advanced or metastatic breast cancer.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - talazoparib tosilate, quantity: 0.363 mg - capsule, hard - excipient ingredients: hypromellose; titanium dioxide; iron oxide yellow; silicified microcrystalline cellulose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - talzenna is indicated for the treatment of patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (brca) mutation according to a validated diagnostic test, who have human epidermal growth factor receptor 2 (her2)-negative, locally advanced or metastatic breast cancer.

Spojené štáty - angličtina - NLM (National Library of Medicine)

bluebird bio, inc. - elivaldogene autotemcel (unii: kum75td6sg) (elivaldogene autotemcel - unii:kum75td6sg) - skysona is indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (cald). early, active cerebral adrenoleukodystrophy refers to asymptomatic or mildly symptomatic (neurologic function score, nfs ≤ 1) boys who have gadolinium enhancement on brain magnetic resonance imaging (mri) and loes scores of 0.5-9. this indication is approved under accelerated approval based on 24-month major functional disability (mfd)-free survival [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). limitations of use skysona does not prevent the development of or treat adrenal insufficiency due to adrenoleukodystrophy. an immune response to skysona may limit the persistence of descendent cells of skysona, causing rapid loss of efficacy of skysona in patients with full deletions of the human adenosine triphosphate binding cassette, sub family d, member 1 (abcd1) transgene. skysona has not been studied in patients with cald secondary to head trauma. given the risk of hematologic malignancy with skysona, and unclear long-term durability of skysona and human adrenoleukodystrophy protein (aldp) expression, careful consideration should be given to the appropriateness and timing of treatment for each boy, especially for boys with isolated pyramidal tract disease based on available treatment options since their clinical symptoms do not usually occur until adulthood. none. risk summary there are no available data with skysona administration in pregnant women. consider the risks associated with mobilization and conditioning agents on pregnancy and fertility. no animal reproductive and developmental toxicity studies have been conducted to assess whether skysona can cause fetal harm when administered to a pregnant woman. no nonclinical germline transmission studies have been conducted with skysona. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there is no information regarding the presence of skysona in human milk, the effect on the breastfed infant, and the effects on milk production. contraception consult the prescribing information of the mobilization and conditioning agents for information on the need for effective contraception. there are insufficient exposure data to provide a precise recommendation on duration of contraception following treatment with skysona. males capable of fathering a child and their female partners of childbearing potential should use an effective method of contraception (intra-uterine device or combination of hormonal and barrier contraception) from start of mobilization through at least 6 months after administration of skysona. infertility there are no data on the effects of skysona on fertility. data are available on the risk of infertility with myeloablative conditioning. advise patients of the option to cryopreserve semen before treatment if appropriate. the safety and efficacy of skysona in children less than 4 years of age have not been established. no data are available [see clinical studies (14)] . in the only patient in the skysona clinical studies who had a full abcd1 deletion, disease progression occurred. the patient experienced radiologic disease progression in the setting of declining peripheral blood vector copy number, suggesting loss of product efficacy which may have been immune mediated. the patient was subsequently treated with allogeneic hematopoietic stem cell transplant. skysona has not been studied in patients with renal impairment. patients should be assessed for renal impairment to ensure hematopoietic stem cell (hsc) transplantation is appropriate. skysona has not been studied in patients with hepatic impairment. patients should be assessed for hepatic impairment to ensure hsc transplantation is appropriate. skysona has not been studied in patients with hiv-1, hiv-2, htlv-1, or htlv-2. a negative serology test for hiv is necessary to ensure acceptance of apheresis material for skysona manufacturing. apheresis material from patients with a positive test for hiv will not be accepted for skysona manufacturing.

Kanada - angličtina - Health Canada

astrazeneca canada inc - olaparib - tablet - 100mg - olaparib 100mg - antineoplastic agents

Kanada - angličtina - Health Canada

astrazeneca canada inc - olaparib - tablet - 150mg - olaparib 150mg - antineoplastic agents

Singapur - angličtina - HSA (Health Sciences Authority)

astrazeneca singapore pte ltd - olaparib - tablet, film coated - olaparib 100mg