Malta - English - Medicines Authority

elc group s.r.o. pobrezni 394/12, karlin 186 00 prague 8, czech republic - phloroglucinol dihydrate - orodispersible tablet - phloroglucinol dihydrate 80 mg - drugs for functional gastrointestinal disorders

Malta - English - Medicines Authority

elc group s.r.o. pobrezni 394/12, karlin 186 00 prague 8, czech republic - levodropropizine - syrup - levodropropizine 30 ml/5ml - cough and cold preparations

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

daiichi sankyo inc. - colesevelam hydrochloride (unii: p4sg24wi5q) (colesevelam - unii:1xu104g55n) - colesevelam hydrochloride 625 mg - welchol is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia. welchol is indicated to reduce ldl-c levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (hefh) who are unable to reach ldl-c target levels despite an adequate trial of dietary therapy and lifestyle modification. welchol is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. - welchol should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. - welchol has not been studied in fredrickson type i, iii, iv, and v dyslipidemias. welchol is contraindicated in patients with: - serum tg concentrations >500 mg/dl [see warnings and precautions (5.1)] - history of hypertriglyceridemia-induced pancreatitis [see warnings and precautions (5.1)] - a history of bowel obstruction [see warnings and precaution

European Union - English - EMA (European Medicines Agency)

janssen-cilag international nv - bortezomib - multiple myeloma - antineoplastic agents - velcade as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.velcade in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high dose chemotherapy with haematopoietic stem cell transplantation.velcade in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high dose chemotherapy with haematopoietic stem cell transplantation.velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

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

amgen inc - etelcalcetide hydrochloride (unii: 72pt5993du) (etelcalcetide - unii:60me133fjb) - etelcalcetide 2.5 mg in 0.5 ml - parsabiv is indicated for the treatment of secondary hyperparathyroidism (hpt) in adult patients with chronic kidney disease (ckd) on hemodialysis. limitations of use: parsabiv has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who are not on hemodialysis and is not recommended for use in these populations. hypersensitivity parsabiv is contraindicated in patients with known hypersensitivity to etelcalcetide or any of its excipients. hypersensitivity reactions, including face edema and anaphylactic reaction, have occurred with parsabiv [see adverse reactions (6)] . risk summary there are no available data on the use of parsabiv in pregnant women. in animal reproduction studies, effects were seen at doses associated with maternal toxicity that included hypocalcemia. in a pre- and post-natal study in rats administered etelcalcetide during organogenesis through delivery and weaning, there was a slight increase in perinatal pup mortality,

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

janssen-cilag pty ltd - bortezomib, quantity: 3 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - - velcade, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. - velcade, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. - velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

janssen-cilag pty ltd - bortezomib, quantity: 1 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - - velcade, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. - velcade, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. - velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

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

janssen-cilag pty ltd - bortezomib, quantity: 3.5 mg - injection, powder for - excipient ingredients: mannitol; nitrogen - - velcade, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. - velcade, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. - velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Singapore - English - HSA (Health Sciences Authority)

welch allyn singapore pte. ltd. - ear, nose & throat - the welch allyn oae hearing screener is indicated for testing of cochlear function in infants, children and adults by measuring otoacoustic emissions (oaes). the oaes are generated by a series of clicks that are directed into the ear canal.

Singapore - English - HSA (Health Sciences Authority)

welch allyn singapore pte. ltd. - cardiovascular - the spot check device is intended for measurement of blood pressure, pulse rate, temperature and oxygen saturation (spo2) of adult and pediatric patients. the welch allyn spot check device is not designed for use with neonates. the welch allyn spot check device should not be used on patients who are linked to heart/lung machines. the welch allyn spot check device is not designed for use of axillary temperature option above three years of age in children. the welch allyn spot check device is not intended to monitor patient’s vital signs. the welch allyn spot check device is not defibrillator proof.