Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

hovid berhad - cod liver oil -

United States - English - NLM (National Library of Medicine)

biomarin pharmaceutical inc. - valoctocogene roxaparvovec (unii: 681k1jdi8m) (valoctocogene roxaparvovec - unii:681k1jdi8m) - roctavian is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia a (congenital factor viii deficiency with factor viii activity < 1 iu/dl) without antibodies to adeno-associated virus serotype 5 (aav5) detected by an fda-approved test. administration of roctavian is contraindicated in: - patients with active infections, either acute (such as acute respiratory infections or acute hepatitis) or uncontrolled chronic (such as chronic active hepatitis b). - patients with known significant hepatic fibrosis (stage 3 or 4 on the batts-ludwig scale or equivalent), or cirrhosis [see dosage and administration (2)]. - patients with known hypersensitivity to mannitol. risk summary roctavian is not intended for administration in women. there are no data on the use of roctavian in pregnant women to inform a drug-associated risk of adverse developmental outcome. animal reproduction and developmental toxicity studies have not been conducted with roctavian. it is not known whether roctavian can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects occurs in 2 to 4% of the general population and miscarriage occurs in 15 to 20% of clinically recognized pregnancies. risk summary roctavian is not intended for administration in women. there is no information regarding the presence of roctavian in human milk, the effects on the breastfed infant, or the effects on milk production. roctavian is not intended for administration in women. contraception after administration to males in clinical studies, after administration of roctavian, transgene dna was detectable in semen [see clinical pharmacology (12.3)] . in nonclinical studies in healthy mice, the vector dna was detected in the testes for at least 182 days post-administration of roctavian at a dose level of 2.1 × 1014 vg/kg [see clinical pharmacology (12.3)]. in a mating study in immune-deficient mice, roctavian was not detected in liver tissues of offspring of naïve females mated with dosed males [see nonclinical toxicology (13.1)]. for 6 months after administration of roctavian - men of reproductive potential and their female partners must prevent or postpone pregnancy using an effective form of contraception, and - men must not donate semen. the safety and effectiveness of roctavian in pediatric patients have not been established. a single patient ≥ 65 years of age was treated with rocatvian in clinical studies. clinical studies of roctavian did not include sufficient numbers of patients aged 65 and over to determine whether the efficacy or safety differs compared to younger patients. in clinical studies, 3 hiv infected patients have been treated with roctavian. clinical studies of roctavian did not include sufficient numbers of patients with hiv to determine whether the efficacy and safety differs compared to patients without hiv infection. a single hiv infected patient treated with roctavian developed hepatocellular injury that subsequently resolved and was attributed to concomitant administration with antiretroviral drug efavirenz [see drug interactions (7.2)] . the safety and effectiveness of roctavian in patients with prior or active factor viii inhibitors have not been established [see clinical pharmacology (12.6)] . patients with active factor viii inhibitors should not take roctavian. after administration of roctavian, patients should be monitored for the development of factor viii inhibitors by appropriate clinical observations and laboratory tests [see warnings and precautions (5.4)] . the safety and effectiveness of roctavian in patients with hepatic impairment has not been established. clinical studies excluded patients with known hepatic cirrhosis, significant fibrosis (stage 3 or 4 on the batts-ludwig scale or equivalent), current hepatitis b or c, or history of hepatic malignancy. no dose adjustments can be recommended for patients with hepatic impairment. the safety and effectiveness of roctavian in patients with renal impairment has not been established. no dose adjustments can be recommended for patients with renal impairment.

Canada - English - Health Canada

biomarin pharmaceutical inc. - galsulfase - solution - 1mg - galsulfase 1mg - enzymes

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

biomarin europe ltd - galsulfase - solution for infusion - 1mg/1ml

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

biomarin pharmaceutical australia pty ltd - galsulfase -

United States - English - NLM (National Library of Medicine)

biomarin pharmaceutical inc. - sapropterin dihydrochloride (unii: rg277lf5b3) (sapropterin - unii:egx657432i) - sapropterin dihydrochloride 100 mg - kuvan® is indicated to reduce blood phenylalanine (phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (hpa) due to tetrahydrobiopterin- (bh4-) responsive phenylketonuria (pku). kuvan is to be used in conjunction with a phe-restricted diet. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to kuvan during pregnancy. for more information regarding the registry program call 1-800-983-4587. risk summary available pregnancy registry data  have not reported an  association with kuvan and major birth defects, miscarriage, or adverse maternal or fetal outcomes when kuvan was used during pregnancy (see data) . an embryo-fetal development study with sapropterin dihydrochloride in rats using oral doses up to 3 times the maximum recommended human dose (mrhd) given during the period of organogenesis showed no effects. in a rabbit study using oral administration of sapropterin dihydrochloride dur

United States - English - NLM (National Library of Medicine)

biomarin pharmaceutical inc. - cerliponase alfa (unii: x8r2d92qp1) (cerliponase alfa - unii:x8r2d92qp1) - cerliponase alfa 150 mg in 5 ml - brineura is indicated to slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (cln2), also known as tripeptidyl peptidase 1 (tpp1) deficiency. brineura is contraindicated in patients with: - any sign or symptom of acute, unresolved localized infection on or around the device insertion site (e.g. cellulitis or abscess); or suspected or confirmed cns infection (e.g. cloudy csf or positive csf gram stain, or meningitis) [see warnings and precautions (5.1)] . - any acute intraventricular access device-related complication (e.g., leakage, extravasation of fluid, or device failure) [see warnings and precautions (5.2)] . - ventriculoperitoneal shunts. risk summary there are no available data on brineura use in pregnant women to inform a drug-associated risk of pregnancy-related outcomes. animal reproduction studies have not been conducted using cerliponase alfa. the estimated background risk of major birth defects and miscarr

United States - English - NLM (National Library of Medicine)

biomarin pharmaceutical inc. - galsulfase (unii: 59ua429e5g) (galsulfase - unii:59ua429e5g) - galsulfase 5 mg in 5 ml - naglazyme is indicated for patients with mucopolysaccharidosis vi (mps vi, maroteaux-lamy syndrome).  naglazyme has been shown to improve walking and stair-climbing capacity. none. risk summary available data from case reports and postmarketing experience with naglazyme use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, galsulfase administered intravenously to pregnant rats and rabbits during the period of organogenesis, showed no evidence of harm to the fetus at doses of about 0.5 and 0.97 times, respectively for rats and rabbits, the recommended human dose of 1 mg/kg based on body surface area (see data) .   the estimated background risk of major birth defects and miscarriage for the indicated population is unknown.  all pregnancies have a background risk of birth defects, loss, or other adverse outcomes.  in the u.s. general population, the estimated background risk of majo

United States - English - NLM (National Library of Medicine)

biomarin pharmaceutical inc. - elosulfase alfa (unii: odj69jzg85) (elosulfase alfa - unii:odj69jzg85) - elosulfase alfa 5 mg in 5 ml - vimizim (elosulfase alfa) is indicated for patients with mucopolysaccharidosis type iva (mps iva; morquio a syndrome). none pregnancy exposure registry there is a morquio a registry that collects data on pregnant women with mps iva who are treated with vimizim.  contact mars@bmrn.com or call 1-800-983-4587 for information and enrollment. risk summary available data from published case reports and postmarketing experience with vimizim use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, no effects on embryo-fetal development were observed in rats given daily administration of elosulfase alfa up to 33 times the human steady-state auc (area under the concentration-time curve) at the recommended human weekly dose premating and through the period of organogenesis. no effects on embryo-fetal development were observed in rabbits given daily administration of elosulfase alfa at doses up

United States - English - NLM (National Library of Medicine)

biomarin pharmaceutical inc. - vosoritide (unii: 7se5582q2p) (vosoritide - unii:7se5582q2p) - voxzogo is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. this indication is approved under accelerated approval based on an improvement in annualized growth velocity [see clinical studies (14)] . 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 on vosoritide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of embryo-fetal toxicity or congenital malformations when pregnant rats and rabbits were administered vosoritide subcutaneously at doses equivalent to 14-times and 200-times, respectively, the exposure at the maximum recommended human dose (mrhd) (see data). the estimated background risk of major birth defects for the indicated population is higher than the general population. the est