Malezija - engleski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - adalimumab -

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

abbvie inc. - atogepant (unii: 7crv8rr151) (atogepant - unii:7crv8rr151) - qulipta is indicated for the preventive treatment of migraine in adults. qulipta is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of qulipta. reactions have included anaphylaxis and dyspnea [see warnings and precautions ( 5.1 )] . risk summary there are no adequate data on the developmental risk associated with the use of qulipta in pregnant women. in animal studies, oral administration of atogepant during the period of organogenesis (rats and rabbits) or throughout pregnancy and lactation (rats) resulted in adverse developmental effects (decreased fetal and offspring body weight in rats; increased incidence of fetal structural variations in rabbits) at exposures greater than those used clinically [see data ] . in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. clinical considerations disease-associated maternal and/or embryo/fetal risk published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. data animal data oral administration of atogepant (0, 5, 15, 125, or 750 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal body weight and in skeletal ossification at the two highest doses tested (125 and 750 mg/kg), which were not associated with maternal toxicity.  at the no-effect dose (15 mg/kg/day) for adverse effects on embryofetal development, plasma exposure (auc) was approximately 4 times that in humans at the maximum recommended human dose (mrhd) of 60 mg/day. oral administration of atogepant (0, 30, 90, or 130 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in an increase in fetal visceral and skeletal variations at the highest dose tested (130 mg/kg/day), which was associated with minimal maternal toxicity. at the no-effect dose (90 mg/kg/day) for adverse effects on embryofetal development, plasma exposure (auc) was approximately 3 times that in humans at the mrhd. oral administration of atogepant (0, 15, 45, or 125 mg/kg/day) to rats throughout gestation and lactation resulted in decreased pup body weight at the highest dose tested (125 mg/kg/day), which persisted into adulthood. at the no-effect dose (45 mg/kg/day) for adverse effects on pre- and postnatal development, plasma exposure (auc) was approximately 5 times that in humans at the mrhd. there are no data on the presence of atogepant in human milk, the effects of atogepant on the breastfed infant, or the effects of atogepant on milk production. in lactating rats, oral dosing with atogepant resulted in levels of atogepant in milk approximately 2-fold higher than that in maternal plasma. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for qulipta and any potential adverse effects on the breastfed infant from qulipta or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established.  population pharmacokinetic modeling suggests no clinically significant pharmacokinetic differences between elderly and younger subjects. clinical studies of qulipta did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. the renal route of elimination plays a minor role in the clearance of atogepant [see clinical pharmacology ( 12.3 )] . for episodic migraine, in patients with severe renal impairment (clcr 15-29 ml/min) and in patients with end-stage renal disease (esrd) (clcr <15 ml/min), the recommended dosage of qulipta is 10 mg once daily; in patients with esrd undergoing intermittent dialysis, qulipta should preferably be taken after dialysis [see dosage and administration ( 2.2 ) ] . for chronic migraine, avoid use of qulipta in patients with severe renal impairment and in patients with esrd. no dose adjustment is recommended for patients with mild or moderate renal impairment. no dose adjustment of qulipta is recommended for patients with mild or moderate hepatic impairment. avoid use of qulipta in patients with severe hepatic impairment [see adverse reactions ( 6.1 ) and clinical pharmacology ( 12.3 )] .

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - maribavir (unii: ptb4x93he1) (maribavir - unii:ptb4x93he1) - livtencity is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus (cmv) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet [see use in specific populations (8.4) and clinical studies (14)] . none. risk summary no adequate human data are available to establish whether livtencity poses a risk to pregnancy outcomes. in animal reproduction studies, embryo-fetal survival was decreased in rats, but not in rabbits, at maribavir exposures less than those observed in humans at the recommended human dose (rhd) (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in a combined fertility and embryofetal development study, maribavir was administered to male and female rats at oral doses of 100, 200, or 400 mg/kg/day. females were dosed for 15 consecutive days prior to pairing, throughout pairing, and up to gestation day (gd) 17, while males were dosed 29 days prior to mating and throughout mating. a decrease in the number of viable fetuses and increase in early resorptions and post-implantation losses were observed at ≥100 mg/kg/day (at exposures approximately half the human exposure at the rhd). intermittent reduced body weight gain was observed in pregnant animals at ≥200 mg/kg/day. maribavir had no effect on embryo-fetal growth or development at dose levels up to 400 mg/kg/day, at exposures similar to those observed in humans at the rhd. no significant toxicological effects on embryo-fetal growth or development were observed in rabbits when maribavir was administered at oral doses up to 100 mg/kg/day from gd 8 to 20, at exposures approximately half the human exposure at the rhd. in the pre-and post-natal developmental toxicity study, maribavir was administered to pregnant rats at oral doses of 50, 150, or 400 mg/kg/day from gd 7 to post-natal day (pnd) 21. a delay in developmental milestones was observed, including pinna detachment at doses ≥150 mg/kg/day and eye opening and preputial separation associated with reduced bodyweight gain of the offspring at 400 mg/kg/day. in addition, decreased fetal survival and litter loss was observed due to maternal toxicity and poor maternal care, respectively, at doses ≥150 mg/kg/day. no effects were observed at 50 mg/kg/day (which is estimated to be less than the human exposure at the rhd). no effects on number of offspring, proportion of males, number of live pups, or survival to pnd 4 were observed at any dose in the offspring born to the second generation. risk summary it is not known whether maribavir or its metabolites are present in human or animal milk, affect milk production, or have effects on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for livtencity and any potential adverse effects to the breast-fed child. the recommended dosing regimen in pediatric patients 12 years of age and older and weighing at least 35 kg is the same as that in adults. use of livtencity in this age group is based on the following: - evidence from controlled studies of livtencity in adults - population pharmacokinetic (pk) modeling and simulation demonstrating that age and body weight had no clinically meaningful effect on plasma exposures of livtencity - livtencity exposure is expected to be similar between adults and children 12 years of age and older and weighing at least 35 kg - the course of the disease is similar between adults and pediatric patients to allow extrapolation of data in adults to pediatric patients [see dosage and administration (2.2), clinical pharmacology (12.3) and clinical studies (14)] the safety and effectiveness of livtencity have not been established in children younger than 12 years of age. no dosage adjustment is required for patients over 65 years of age based on the results from population pharmacokinetics analysis [see clinical pharmacology (12.3)] and efficacy and safety data from the clinical studies. in the clinical study 303, 54 patients aged 65 years and over were treated with livtencity. safety, effectiveness, and pharmacokinetics were consistent between elderly patients (≥65 years) and younger patients (<65 years). no dose adjustment of livtencity is needed for patients with mild, moderate, or severe renal impairment [see clinical pharmacology (12.3)] . administration of livtencity in patients with end stage renal disease (esrd), including patients on dialysis, has not been studied. no dose adjustment of livtencity is needed for patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment [see clinical pharmacology (12.3)] . administration of livtencity in patients with severe hepatic impairment has not been studied. livtencity (liv-ten-city) (maribavir) tablets, for oral use this instructions for use contains information on how to prepare and give a dose of livtencity tablets by breaking apart (dispersing) or crushing in drinking water and taking by mouth; or dispersing and giving through a nasogastric (ng) or orogastric (og) tube. read this instructions for use before you prepare or give the first dose of livtencity, and each time you get a refill. ask your healthcare provider or pharmacist if you have any questions. important information you need to know before preparing a dose of livtencity: - you can break apart (disperse) the tablets in drinking water or crush the tablets and mix with drinking water. the tablet will not be completely dispersed in the mixture. - do not mix livtencity with any liquid other than drinking water. - livtencity tablets that have been dispersed in drinking water can be given through a nasogastric (ng) or orogastric (og) tube (french size 10 or larger). - you can prepare the mixture ahead of time and store at room temperature 68°f to 77°f (20°c to 25°c) for up to 8 hours. preparing a dose of livtencity by dispersing or crushing tablets and taking by mouth: gather the following supplies: - small, clean container to place tablets and water in - drinking water step 1: choose a clean, flat work surface. place all supplies on the work surface. step 2: wash and dry your hands well. step 3: get the prescribed number of livtencity tablets needed to prepare the dose. step 4: place the livtencity tablets into the container. note: if you prefer, you can crush the tablets with a spoon before adding water. step 5: add the amount of drinking water needed for your prescribed dose. step 6: swirl the container gently to disperse the tablets in the water and swallow the mixture right away. the mixture will have a bitter taste. step 7: rinse the container with 15 ml of drinking water and swallow the mixture. repeat step 7. check that no pieces of tablet are left in the container. repeat step 7 until no pieces remain. preparing and giving a dose of livtencity through a nasogastric (ng) or orogastric (og) tube: gather the following supplies: - 50 ml or 60 ml syringe - drinking water step 1: remove the cap (if capped) and plunger out of a 50 ml or 60 ml syringe. add 2 tablets into the syringe body and place the plunger back in the syringe. note: only 2 tablets can be given through the ng or og tube at a time. step 2: withdraw 30 ml of drinking water into the syringe. step 3: hold the syringe with the tip pointing upward. pull the plunger back so there is some air space in the syringe. if there is a cap, place the cap back on the syringe. shake the syringe well for about 30 to 45 seconds or until the tablets are completely dispersed. be careful not to spill the contents of the syringe. step 4: remove the cap (if capped) from the syringe again and attach the syringe to the ng or og tube and give the mixture right away. step 5: withdraw 15 ml of drinking water into the same syringe and flush through the ng or og tube. repeat step 5. check that no pieces of tablet are left in the syringe. repeat step 5 until no pieces remain. note: if your prescribed dose is more than 2 tablets, repeat steps 1 through 5 until you give the full prescribed dose. storing livtencity: - store livtencity at room temperature 68°f to 77°f (20°c to 25°c). keep livtencity and all medicines out of the reach of children. for more information, go to www.explorelivtencity.com or call 1-877-takeda-7 (1-877-825-3327). distributed by: takeda pharmaceuticals america, inc., lexington, ma 02421 livtencity® and the livtencity logo® are registered trademarks of takeda pharmaceuticals international ag. takeda® and the takeda logo® are registered trademarks of takeda pharmaceutical company limited. ©2024 takeda pharmaceuticals u.s.a., inc. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. mar358 r4 revised: march 2024

Australija - engleski - Department of Health (Therapeutic Goods Administration)

dentsply sirona pty ltd - 47971 - dental bone matrix implant, synthetic - a spongy, porous scaffold composed of collagenized hydroxyapatite at a mass ratio of 20% collagen and 80% the inorganic mineral particles. the collagen prevents migration of the hydroxyapatite particles and facilitates adaptation to the defect site. the macro and microporous structure of the scaffold allow the infiltration of the bone forming cells, ingrowth of new bone at the implantation and eventually bone remodeling by osteoclasts and osteoblasts. an osteoconductive bone grafting material aimed to fill, augment, or reconstruct periodontal and bony defects of the maxillo-facial complex.

Malezija - engleski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - adalimumab -

Australija - engleski - Department of Health (Therapeutic Goods Administration)

dermocosmetica pty ltd - 59131 - dermal tissue reconstructive material, microbe-derived - profhilo? constitutes a buffered physiological solution of high molecular weight and low molecular weight hyaluronic acid (ha) for preventive and corrective aesthetic medicine treatments and counteracting the skin aging process and maintaining appropriate amounts of ha in the dermal layer. profhilo? is intended for treatment of the malar-zygomatic, sub-malar areas face for contours redefinition and laxity remodeling.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - 47818 - staple line-reinforcement strip - psdv allows for neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling. peri-strip dry with veritas collagen matrix (psdv) is prepared from dehydrated bovine pericardium for reinforcement of the staple line during surgical procedures. psd-v is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed. psd-v can be used for reinforcement of staple lines during bariatric and gastric procedures, inclusive of small bowel.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

orthopath pty ltd - 44738 - orthodontic appliance system, progressive - a progressive device designed to influence the shape and/or function of the stomatognathic system by using a series of preformed teeth aligners/positioners, each worn in succession and changed every few weeks. these are typically custom-made for each patient by, e.g., using computer-generated modeling based on an initial impression and a final position determined in consultation with the orthodontist. this device is typically made of clear hard plastic and is single-use.

Malezija - engleski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - secukinumab -

Malezija - engleski - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - secukinumab -