Singapore - English - HSA (Health Sciences Authority)

abbvie pte. ltd. - botulinum toxin type a - injection, powder, for solution - 200 units - botulinum toxin type a 200 units

Singapore - English - HSA (Health Sciences Authority)

abbvie pte. ltd. - clostridium botulinum toxin type a - injection, powder, for solution - 50 units - clostridium botulinum toxin type a 50 units

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

allergan australia pty ltd - 33525 - biological tissue reconstructive material - juvederm hydrate is a sterile, apyrogenic, physiological solution of hyaluronic acid containing 0.9% mannitol. the gel is presented in a graduated pre-filled syringe for single use. indicated for use in improving skin hydration and elasticity by multi-injection into the dermal epidermal junction and into the superficial dermis.

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

allergan, inc. - risedronate sodium hemi-pentahydrate (unii: hu2yaq274o) (risedronic acid - unii:km2z91756z), risedronate sodium monohydrate (unii: f67l43ut5c) (risedronic acid - unii:km2z91756z) - risedronate sodium 4.3 mg - actonel is indicated for the treatment and prevention of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, actonel reduces the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see clinical studies ( 14.1 , 14.2 ) ]. actonel is indicated for treatment to increase bone mass in men with osteoporosis. actonel is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin d.   actonel is indicated for treatment of paget’s disease of bone in men and women. the optimal duration of use has not been determined. the safety and effectiveness of actonel for the treatment of osteoporosis are based on clinical data of three years duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. actonel is contraindicated in patients with the following conditions: - abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see warnings and precautions ( 5.1 ) ] - inability to stand or sit upright for at least 30 minutes [see   dosage and administration ( 2 ), warnings and precautions ( 5.1 ) ] - hypocalcemia [see  warnings and precautions ( 5.2 ) ] - known hypersensitivity to actonel or any of its excipients. angioedema, generalized rash, bullous skin reactions, stevens-johnson syndrome and toxic epidermal necrolysis have been reported [see  adverse reactions ( 6.2 ) ] risk summary available data on the use of actonel in pregnant women are insufficient to inform a drug-associated risk of adverse maternal or fetal outcomes. discontinue actonel when pregnancy is recognized. in animal reproduction studies, daily oral administration of risedronate to pregnant rats during organogenesis decreased neonatal survival and body weight at doses approximately 5 and 26 times, respectively, the highest recommended human daily dose of 30 mg (based on body surface area, mg/m2 ). a low incidence of cleft palate was observed in fetuses of dams treated at doses approximately equal to the 30 mg human daily dose. delayed skeletal ossification was observed in fetuses of dams treated at approximately 2.5 to 5 times the 30 mg human daily dose. periparturient mortality due to maternal hypocalcemia occurred in dams and neonates upon daily oral administration of risedronate to pregnant rats during mating and/or gestation starting at doses equivalent to the 30 mg daily human dose. bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. the amount of bisphosphonate incorporated into adult bone and available for release into the systemic circulation is directly related to the dose and duration of bisphosphonate use. consequently, based on the mechanism of action of bisphosphonates, there is a potential risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. the impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on this risk has not been studied. the estimated background risk of major birth defects and miscarriage for the indicated populations 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 risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in animal studies, pregnant rats received risedronate sodium during organogenesis at doses equivalent to 1 to 26 times the 30 mg human daily dose (based on body surface area, mg/m2 ). survival of neonates was decreased in dams treated during gestation with oral doses approximately 5 times the human dose, and body weight was decreased in neonates of dams treated with approximately 26 times the human dose. a low incidence of cleft palate was observed in fetuses of dams treated with oral doses approximately equal to the human dose. the number of fetuses exhibiting incomplete ossification of sternebrae or skull of dams treated with approximately 2.5 times the human dose was significantly increased compared to controls. both incomplete ossification and unossified sternebrae were increased in fetuses of dams treated with oral doses approximately 5 times the human dose. no significant ossification effects were seen in fetuses of rabbits treated with oral doses approximately 7 times the human dose (the highest dose tested). however, 1 of 14 litters were aborted and 1 of 14 litters were delivered prematurely. periparturient mortality due to maternal hypocalcemia occurred in dams and neonates when pregnant rats were treated daily during mating and/or gestation with oral doses equivalent to the human dose or higher. risk summary there are no data on the presence of risedronate in human milk, the effects on the breastfed infant, or the effects on milk production. a small degree of lacteal transfer occurred in nursing rats. the concentration of the drug in animal milk does not necessarily predict the concentration of drug in human milk. however, when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for actonel and any potential adverse effects on the breast-fed child from actonel or from the underlying maternal condition. data animal data risedronate was detected in neonates of lactating rats given a single oral dose of risedronate at 24-hours post-dosing, indicating a small degree of lacteal transfer. actonel is not indicated for use in pediatric patients. the safety and effectiveness of risedronate was assessed in a one-year, randomized, double-blind, placebo-controlled study of 143 pediatric patients (94 received risedronate) with osteogenesis imperfecta (oi). the enrolled population was predominantly patients with mild osteogenesis imperfecta (85% type-i), aged 4 to less than 16 years, 50% male and 82% caucasian, with a mean lumbar spine bmd z-score of -2.08 (2.08 standard deviations below the mean for age-matched controls). patients received either a 2.5 mg (less than or equal to 30 kg body weight) or 5 mg (greater than 30 kg body weight) daily oral dose. after one year, an increase in lumbar spine bmd in the risedronate group compared to the placebo group was observed. however, treatment with risedronate did not result in a reduction in the risk of fracture in pediatric patients with osteogenesis imperfecta. in actonel-treated subjects, no mineralization defects were noted in paired bone biopsy specimens obtained at baseline and month 12. the overall safety profile of risedronate in oi patients treated for up to 12 months was generally similar to that of adults with osteoporosis. however, there was an increased incidence of vomiting compared to placebo. in this study, vomiting was observed in 15% of children treated with risedronate and 6% of patients treated with placebo. other adverse events reported in greater than or equal to 10% of patients treated with risedronate and with a higher frequency than placebo were: pain in the extremity (21% with risedronate versus 16% with placebo), headache (20% versus 8%), back pain (17% versus 10%), pain (15% versus 10%), upper abdominal pain (11% versus 8%), and bone pain (10% versus 4%). of the patients receiving actonel in postmenopausal osteoporosis studies [see  c linical s tudies ( 14 ) ], 47% were between 65 and 75 years of age, and 17% were over 75. the corresponding proportions were 26% and 11% in glucocorticoid-induced osteoporosis trials, and 40% and 26% in paget’s disease trials. no overall differences in efficacy between geriatric and younger patients were observed in these studies. in the male osteoporosis trial, 28% of patients receiving actonel were between 65 and 75 years of age and 9% were over 75. the lumbar spine bmd response for actonel compared to placebo was 5.6% for subjects less than 65 years and 2.9% for subjects greater than or equal to 65 years. no overall differences in safety between geriatric and younger patients were observed in the actonel trials, but greater sensitivity of some older individuals cannot be ruled out. actonel is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 ml/min) because of lack of clinical experience. no dosage adjustment is necessary in patients with a creatinine clearance greater than or equal to 30 ml/min. no studies have been performed to assess risedronate’s safety or efficacy in patients with hepatic impairment. risedronate is not metabolized in human liver preparations. dosage adjustment is unlikely to be needed in patients with hepatic impairment.

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

allergan, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 50 [usp'u] - botox cosmetic (onabotulinumtoxina) is indicated in adult patients for the temporary improvement in the appearance of: - moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity - moderate to severe lateral canthal lines  associated with orbicularis oculi activity - moderate to severe forehead lines associated with frontalis muscle activity botox cosmetic is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [see warnings and precautions ( 5.4 )] . botox cosmetic is contraindicated in the presence of infection at the proposed injection site(s). risk summary there are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of botox cosmetic in pregnant women.   in animal studies, administrations of botox cosmetic during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [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 background risk of major birth defects and miscarriage for the indicated populations is unknown. data animal data when botox cosmetic (4, 8, or 16 units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were observed at the two highest doses. the no-effect dose for developmental toxicity in these studies (4 units/kg) is approximately 4 times the average high human dose for glabellar lines, lateral canthal lines, and forehead lines of 64 units on a body weight basis (units/kg). when botox cosmetic was administered intramuscularly to pregnant rats (0.125, 0.25, 0.5, 1, 4, or 8 units/kg) or rabbits (0.063, 0.125, 0.25, or 0.5 units/kg) daily during the period of organogenesis (total of 12 doses in rats, 13 doses in rabbits), reduced fetal body weights and decreased fetal skeletal ossification were observed at the two highest doses in rats and at the highest dose in rabbits. these doses were also associated with significant maternal toxicity, including abortions, early deliveries, and maternal death. the developmental no-effect doses in these studies of 1 unit/kg in rats is approximately equal the average high human dose of 64 units based on units/kg, and the developmental no-effect dose of 0.25 units/kg in rabbits is less than the average high human dose based on units/kg. when pregnant rats received single intramuscular injections (1, 4, or 16 units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal development were observed. the developmental no-effect level for a single maternal dose in rats (16 units/kg) is approximately 16 times the average high human dose of 64 units based on units/kg. risk summary there are no data on the presence of botox cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.   the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for botox cosmetic and any potential adverse effects on the breastfed infant from botox cosmetic or from the underlying maternal conditions. safety and effectiveness in patients below the age of 18 years have not been established. glabellar lines in the two initial glabellar lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older [see clinical studies ( 14 )] . lateral canthal lines in the two lateral canthal lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older. forehead lines in the two forehead lines clinical studies of botox cosmetic, the responder rates appeared to be higher for subjects younger than age 65 than for subjects 65 years or older.

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

allergan, inc. - botulinum toxin type a (unii: e211kpy694) (botulinum toxin type a - unii:e211kpy694) - botulinum toxin type a 100 [usp'u] - overactive bladder botox  for injection is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication. detrusor overactivity associated with a neurologic condition botox  is indicated for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (e.g., sci, ms) in adults who have an inadequate response to or are intolerant of an anticholinergic medication. botox is indicated for the treatment of neurogenic detrusor overactivity (ndo) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. botox is indicated for the prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer). limitations of use safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies. botox is indicated for the treatment of spasticity in patients 2 years of age and older. limitations of use   botox has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. botox is indicated for the treatment of adults with cervical dystonia, to reduce the severity of abnormal head position and neck pain associated with cervical dystonia. botox is indicated for the treatment of severe primary axillary hyperhidrosis that is inadequately managed with topical agents. limitations of use the safety and effectiveness of botox for hyperhidrosis in other body areas have not been established. weakness of hand muscles and blepharoptosis may occur in patients who receive botox for palmar hyperhidrosis and facial hyperhidrosis, respectively. patients should be evaluated for potential causes of secondary hyperhidrosis (e.g., hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis and/or treatment of the underlying disease. safety and effectiveness of botox have not been established for the treatment of axillary hyperhidrosis in pediatric patients under age 18. botox is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or vii nerve disorders in patients 12 years of age and older. botox is contraindicated: - in patients who are hypersensitive to any botulinum toxin product or to any of the components in the formulation [see warnings and precautions ( 5.4 )] .  - in the presence of infection at the proposed injection site(s). - for intradetrusor injection in patients with a urinary tract infection; or in patients with urinary retention or post-void residual (pvr) urine volume >200 ml who are not routinely performing clean intermittent self-catheterization (cic) [see warnings and precautions ( 5.12 , 5.13 )] . risk summary there are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of botox in pregnant women. in animal studies, administration of botox during pregnancy resulted in adverse effects on fetal growth (decreased fetal weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [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 background risk of major birth defects and miscarriage for the indicated populations is unknown. data animal data when botox (4, 8, or 16 units/kg) was administered intramuscularly to pregnant mice or rats two times during the period of organogenesis (on gestation days 5 and 13), reductions in fetal body weight and decreased fetal skeletal ossification were observed at the two highest doses. the no-effect dose for developmental toxicity in these studies (4 units/kg) is approximately equal to the human dose of 400 units, on a body weight basis (units/kg). when botox was administered intramuscularly to pregnant rats (0.125, 0.25, 0.5, 1, 4, or 8 units/kg) or rabbits (0.063, 0.125, 0.25, or 0.5 units/kg) daily during the period of organogenesis (total of 12 doses in rats, 13 doses in rabbits), reduced fetal body weights and decreased fetal skeletal ossification were observed at the two highest doses in rats and at the highest dose in rabbits. these doses were also associated with significant maternal toxicity, including abortions, early deliveries, and maternal death. the developmental no-effect doses in these studies of 1 unit/kg in rats and 0.25 units/kg in rabbits are less than the human dose of 400 units, based on units/kg. when pregnant rats received single intramuscular injections (1, 4, or 16 units/kg) at three different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal development were observed. the developmental no-effect level for a single maternal dose in rats (16 units/kg) is approximately 2 times the human dose of 400 units, based on units/kg. risk summary there are no data on the presence of botox in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for botox and any potential adverse effects on the breastfed infant from botox or from the underlying maternal conditions. detrusor overactivity associated with a neurologic condition the safety and effectiveness of botox for detrusor overactivity associated with a neurologic condition have been established in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. use of botox in this patient population is based on the results of a randomized, double-blind, parallel group trial in 113 pediatric patients 5 to 17 years of age (inclusive) with detrusor overactivity associated with a neurologic condition (study 191622-120) and a long-term, multicenter, double-blind, long-term extension trial (study 191622-121) [see clinical studies ( 14.3 )]. the most common adverse reactions in this population were urinary tract infection, bacteriuria, hematuria, and leukocyturia [see adverse reactions   ( 6.1 ) ] . the safety and effectiveness of botox have not been established in patients with ndo younger than 5 years of age. overactive bladder the safety and effectiveness of botox for the treatment of overactive bladder have not been established in pediatric patients. efficacy was not demonstrated in a multicenter, randomized, double-blind, parallel-group, multiple-dose clinical study which was conducted to evaluate the efficacy and safety of botox in pediatric patients aged 12 to 17 years with overactive bladder. fifty-five patients who had an inadequate response to or were intolerant of at least one anticholinergic medication were treated with botox. there was not a statistically significant difference in the mean change from baseline in the daily average frequency of daytime urinary incontinence episodes (primary efficacy endpoint) at week 12 post-treatment when a medium and high dose were each compared to a low dose of botox. the adverse reactions in pediatric patients treated with botox were comparable with the known safety profile in adults with overactive bladder.  prophylaxis of headaches in chronic migraine safety and effectiveness in patients below the age of 18 years have not been established. in a 12-week, multicenter, double-blind, placebo-controlled clinical trial, 123 adolescent patients (ages 12 to below 18 years) with chronic migraine were randomized to receive botox 74 units, botox 155 units, or placebo, for one injection cycle. this trial did not establish the efficacy of botox, compared with placebo, for the prophylaxis of headaches in adolescents with chronic migraine. spasticity safety and effectiveness have been established in pediatric patients 2 to 17 years of age [see warnings and precautions ( 5.1 ), adverse reactions ( 6.1 ) , and clinical studies ( 14.6 )] . the safety and effectiveness of botox have been established by evidence from adequate and well-controlled studies of botox in patients 2 to 17 years of age with upper and lower limb spasticity. safety and effectiveness in pediatric patients below the age of 2 years have not been established [see boxed warning and warnings and precautions ( 5.1 )]. axillary hyperhidrosis safety and effectiveness in patients below the age of 18 years have not been established. cervical dystonia safety and effectiveness in pediatric patients below the age of 16 years have not been established. blepharospasm and strabismus safety and effectiveness in pediatric patients below the age of 12 years have not been established. juvenile animal data in a study in which juvenile rats received intramuscular injection of botox (0, 8, 16, or 24 units/kg) every other week from postnatal day 21 for 12 weeks, changes in bone size/geometry associated with decreased bone density and bone mass were observed at all doses, in association with limb disuse, decreased muscle contraction, and decreased body weight gain. impairment of fertility and male reproductive organ histopathology (degeneration of seminiferous tubules of the testis) were observed at the mid and high doses. bone and male reproductive organ effects showed evidence of reversibility after dosing cessation. the no-effect dose for adverse developmental effects in juvenile animals (8 units/kg) is similar to the human dose (400 units) on a body weight (kg) basis. of the 2145 adult patients in placebo-controlled clinical studies of botox for the treatment of spasticity, 33.5% were 65 or older, and 7.7% were 75 years of age or older. no overall differences in safety were observed between elderly patients and adult patients younger than 65 years of age.  in clinical studies of botox across other indications, no overall differences in safety were observed between elderly patients and younger adult patients, with the exception of overactive bladder (see below). other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. overactive bladder of 1242 overactive bladder patients in placebo-controlled clinical studies of botox, 41.4% were 65 years of age or older, and 14.7% were 75 years of age or older. adverse reactions of uti and urinary retention were more common in patients 65 years of age or older in both placebo and botox groups compared to younger patients (see table 24). otherwise, there were no overall differences in the safety profile following botox treatment between patients aged 65 years and older compared to adult patients younger than 65 years of age in these studies. observed effectiveness was comparable between these age groups in placebo-controlled clinical studies.

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

allergan, inc. - risedronate sodium hemi-pentahydrate (unii: hu2yaq274o) (risedronic acid - unii:km2z91756z), risedronate sodium monohydrate (unii: f67l43ut5c) (risedronic acid - unii:km2z91756z) - risedronate sodium anhydrous 30.1 mg - atelvia is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [see clinical studies (14.1) ]. the optimal duration of use has not been determined. the safety and effectiveness of atelvia for the treatment of osteoporosis are based on clinical data of one year duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. atelvia is contraindicated in patients with the following conditions: • abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see warnings and precautions (5.2) ]  • inability to stand or sit upri

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

allergan, inc. - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 10 mg - celexa is indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies ( 14 )] . celexa is contraindicated in patients: - taking, or within 14 days of stopping, maois (including maois such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.3 ), drug interactions ( 7 )] . - taking pimozide because of risk of qt prolongation [ see drug interactions ( 7 )] . - with known hypersensitivity to citalopram or any of the inactive ingredients in celexa. reactions have included angioedema and anaphylaxis [see adverse reactions ( 6.2 ) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to advise patients to register by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregist

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

allergan, inc. - linaclotide (unii: n0txr0xr5x) (linaclotide - unii:n0txr0xr5x) - linaclotide 145 ug - linzess is indicated for the treatment of: • irritable bowel syndrome with constipation (ibs-c) in adults • chronic idiopathic constipation (cic) in adults • functional constipation (fc) in pediatric patients 6 to 17 years of age linzess is contraindicated in: - patients less than 2 years of age due to the risk of serious dehydration [see warnings and precautions ( 5.1 ), use in specific populations ( 8.4 )] . - patients with known or suspected mechanical gastrointestinal obstruction.  risk summary linaclotide and its active metabolite are negligibly absorbed systemically following oral administration [see clinical pharmacology ( 12.3 )] , and maternal use is not expected to result in fetal exposure to the drug. the available data on linzess use in pregnant women are not sufficient to inform any drug-associated risk for major birth defects and miscarriage. in animal developmental studies, no effects on embryo-fetal development were observed with oral administration of linaclotide in rats and rabbits during o

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

allergan malaysia sdn bhd - ketorolac tromethamine; ketorolac tromethamine -