Singapore - Tiếng Anh - HSA (Health Sciences Authority)

teva pharmaceutical investments singapore pte. ltd. - lipegfilgrastim - injection, solution - lipegfilgrastim 6.00 mg/0.6ml

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - acalabrutinib (unii: i42748elqw) (acalabrutinib - unii:i42748elqw) - acalabrutinib 100 mg - calquence is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy. this indication is approved under accelerated approval based on overall response rate [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. calquence is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll). none. risk summary based on findings in animals, calquence may cause fetal harm and dystocia when administered to a pregnant woman. there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of acalabrutinib to animals during organogenesis resulted in dystocia in rats and reduced fetal growth in rabbits at maternal exposures (auc) 2 times exposures in patients at the recommended dose of 100 mg approximately every 12 hours (s

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - acalabrutinib (unii: i42748elqw) (acalabrutinib - unii:i42748elqw) - calquence is indicated for the treatment of adult patients with mantle cell lymphoma (mcl) who have received at least one prior therapy. this indication is approved under accelerated approval based on overall response rate [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. calquence is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll). none. risk summary based on findings in animals, calquence may cause fetal harm and dystocia when administered to a pregnant woman. there are no available data in pregnant women to inform the drug-associated risk. in animal reproduction studies, administration of acalabrutinib to animals during organogenesis resulted in dystocia in rats and reduced fetal growth in rabbits at maternal exposures (auc) 2 times exposures in patients at the recommended dose of 100 mg approximately every 12 hours (s

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

iq medical - 35907 - aqueous/vitreous humour replacement medium - an artificial hpmc-based sterile, isotonic, non-pyrogenic, non-inflammatory viscoelastic fluid for use in ophthalmic anterior segment surgery to replace the aqueous or vitreous humour within the eye to assist in the surgical procedure.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

bausch & lomb australia pty ltd - 35907 - aqueous/vitreous humour replacement medium - a liquid substance used to replace the aqueous or vitreous humour within the eye.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

beaver-visitec international australia pty ltd - 35907 - aqueous/vitreous humour replacement medium - purified liquid perfluorocarbon used in ophthalmic surgery to replace the aqueous or vitreous humour within the eye and act as a tamponade.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

alcon laboratories australia pty ltd - 36108 - aqueous/vitreous humour replacement medium kit - surgical aid for ophthalmic surgery to replace aqueous/vitreous fluid

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

lumos medical pty ltd - 36108 - aqueous/vitreous humour replacement medium kit - intended as a volume substitute for aqueous humor during intraocular operations, such as lens extraction and insertion of an intraocular lens. it consists of hydroxypropylmethylcellulose (hpmc) and is non-implantable. at the end of surgery, the product must be removed completely using a suitable irrigation/ aspiration device.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

surgivision pty ltd - 36108 - aqueous/vitreous humour replacement medium kit - an isotonic, clear, viscoelastic and sterile solution intended as a volume substitute for aqueous humour during intraocular operations. supplied in syringe with single-use injection cannula. the product is removed after surgery.

Canada - Tiếng Anh - Health Canada

teva canada limited - quetiapine (quetiapine fumarate) - tablet - 25mg - quetiapine (quetiapine fumarate) 25mg - atypical antipsychotics