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

novartis pharmaceuticals corporation - tisagenlecleucel (unii: q6c9whr03o) (tisagenlecleucel - unii:q6c9whr03o) - tisagenlecleucel 2000000 - kymriah is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of: patients up to 25 years of age with b-cell precursor acute lymphoblastic leukemia (all) that is refractory or in second or later relapse. adult patients with relapsed or refractory (r/r) large b-cell lymphoma after two or more lines of systemic therapy including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, high grade b-cell lymphoma and dlbcl arising from follicular lymphoma. limitation of use: kymriah is not indicated for treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory (r/r) follicular lymphoma (fl) after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate and duration of response [see clinical studies (14.3)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary there are no available data with kymriah use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with kymriah to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if kymriah has the potential to be transferred to the fetus. based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including b-cell lymphocytopenia. therefore, kymriah is not recommended for women who are pregnant, and pregnancy after kymriah administration should be discussed with the treating physician. report pregnancies to novartis pharmaceuticals corporation at 1-888-669-6682.  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 kymriah in human milk, the effect on the breastfed infant, and the effects on milk production. a risk to the breastfed infant cannot be excluded. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kymriah and any potential adverse effects on the breastfed infant from kymriah or from the underlying maternal condition. pregnancy testing pregnancy status of females with reproductive potential should be verified. sexually-active females of reproductive potential should have a pregnancy test prior to starting treatment with kymriah. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with kymriah. infertility there are no data on the effect of kymriah on male and female fertility. the safety and efficacy of kymriah have been established in pediatric patients with r/r b-cell all. use of kymriah is supported by a single-arm trial [see clinical studies (14.1)] that included 61 pediatric patients with r/r b-cell precursor all in the following age groups: 40 children (ages 2 years to less than 12 years) and 21 adolescents (ages 12 years to less than 17 years). no differences in efficacy or safety were observed between the different age subgroups or in comparison to the young adults in the trial. the safety and efficacy of kymriah in pediatric patients with r/r dlbcl and r/r fl have not been established. the safety and effectiveness of kymriah have not been established in geriatric patients with r/r b-cell all. clinical studies of kymriah did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

New Zealand - Inggeris - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - molnupiravir 200mg;  ;  ;   - capsule - 200 mg - active: molnupiravir 200mg       excipient: croscarmellose sodium hyprolose hypromellose ink iron oxide red magnesium stearate microcrystalline cellulose titanium dioxide - lagevrio is indicated for the treatment of mild to moderate coronavirus disease 2019 (covid-19) in adults aged 18 years and older who are at increased risk of progressing to severe covid-19, hospitalisation or death.

Kesatuan Eropah - Inggeris - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - colesevelam (as hydrochloride) - hypercholesterolemia - lipid modifying agents - cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-a (hmg-coa)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (ldl-c) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and ldl-c in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).

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

novartis pharmaceuticals australia pty ltd - tisagenlecleucel -

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

novartis pharmaceuticals australia pty ltd - tisagenlecleucel -

Malta - Inggeris - Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 200 mg - all other therapeutic products

Malta - Inggeris - Medicines Authority

pharmazac, s.a. 31 naousis str., 104 47, athens,, greece - sugammadex - solution for injection - sugammadex 500 mg - all other therapeutic products

Australia - Inggeris - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - newcastle disease strain v-4 virus - misc. vaccines or anti sera - newcastle disease strain v-4 virus vaccine-viral active 0.0 undefined - immunotherapy - poultry broilers (meat for human consum) | chickens | chooks | meat birds - newcastle disease

Australia - Inggeris - APVMA (Australian Pesticides and Veterinary Medicines Authority)

zoetis australia pty ltd - newcastle disease strain v-4 virus - parenteral liquid/solution/suspension - newcastle disease strain v-4 virus vaccine-viral active 0.0 p - immunotherapy - poultry | breeders | broiler | chickens | chicks | chooks | day old chicks | hatchlings | layers - newcastle disease

Kesatuan Eropah - Inggeris - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole mylan pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.