Belçika - İngilizce - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ursapharm benelux b.v. - azelastine hydrochloride 0,5 mg/ml - eye drops, solution - 0,5 mg/ml - azelastine hydrochloride 0.5 mg/ml - azelastine

Belçika - İngilizce - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

ursapharm benelux b.v. - azelastine hydrochloride 1 mg/ml - nasal spray, solution - 1 mg/ml - azelastine hydrochloride 1 mg/ml - azelastine

Panama - İngilizce - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

octapharma ag - proteÍna total (imunoglobulina g humana polivalente ≥ 95%) - proteÍna total (imunoglobulina g humana polivalente ≥ 95%)....50 mg.

Malezya - İngilizce - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

nutrichampz (m) sdn bhd - phyllanthus urinaria; silybum marianum; cynara scolymus -

Birleşik Krallık - İngilizce - MHRA (Medicines & Healthcare Products Regulatory Agency)

imported (costa rica) - central american lancehead snake venom antiserum; tropical rattlesnake venom antiserum; south american bushmaster snake venom antiserum - solution for injection

Panama - İngilizce - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

merck sharp & dohme corp. - polisacarido (aislado de streptococcus pneumoniae): 1, 2, 3, 4, 5, 6b, 7f, 8, 9n, 9v, 10a, 11a, 12f, 14, 15b, 17f, 18c, 19f, 19a, 20, 22f, 23f, 33f - polisacarido (aislado de streptococcus pneumoniae): 1, 2, 3, 4, 5, 6b, 7f, 8, 9n, 9v, 10a, 11a, 12f, 14, 15b, 17f, 18c, 19f, 19a, 20, 22f, 23f, 33f....25 µg (0.0005 %) de cada policasarido.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

accord healthcare s.l.u. - docetaxel - head and neck neoplasms, carcinoma, non-small-cell lung, adenocarcinoma, prostatic neoplasms, breast neoplasms - antineoplastic agents, - breast cancerdocetaxel accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.for patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.docetaxel accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.docetaxel accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.docetaxel accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer w

ABD - İngilizce - NLM (National Library of Medicine)

medicure international inc - pitavastatin (unii: m5681q5f9p) (pitavastatin - unii:m5681q5f9p) - pitavastatin 1 mg - zypitamag is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (ldl-c) in adults with primary hyperlipidemia. pediatric use information is approved for kowa co ltd livalo (pitavastatin) tablets. however, due to kowa co ltd marketing exclusivity rights, this drug product is not labeled with that information. zypitamag is contraindicated in the following conditions: - concomitant use of cyclosporine [see drug interactions (7)] . - acute liver failure or decompensated cirrhosis [see warnings and precautions (5.3)] - hypersensitivity to pitavastatin or any excipients in zypitamag. hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with pitavastatin [see adverse reactions (6)] . risk summary discontinue zypitamag when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. zypitamag decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, zypitamag may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations. published data from prospective and retrospective observational cohort studies with statin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see data) . in animal reproduction studies, no embryo-fetal toxicity or congenital malformations were observed in pregnant rats or rabbits orally administered pitavastatin during the period of organogenesis at doses that resulted in 22 and 4 times, respectively, the human exposure at the maximum recommended human dose (mrhd) of 4 mg, based on auc (see data) . the estimated 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% to 4% and 15% to 20%, respectively. data human data a medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use -using propensity score-based methods. the relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. there were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. in the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for use of a statin, and a lack of information on non-live births. animal data embryo-fetal developmental studies were conducted in pregnant rats administered 3 mg/kg/day, 10 mg/kg/day, 30 mg/kg/day pitavastatin by oral gavage during organogenesis (gestation day 7-17). no adverse effects were observed at 3 mg/kg/day, systemic exposures 22 times human systemic exposure at 4 mg/day based on auc. embryo-fetal developmental studies were conducted in pregnant rabbits administered 0.1 mg/kg/day, 0.3 mg/kg/day, 1 mg/kg/day pitavastatin by oral gavage during the period of fetal organogenesis (gestation day 6-18). maternal toxicity consisting of reduced body weight and abortion was observed at all doses tested (4 times human systemic exposure at 4 mg/day based on auc). in perinatal/postnatal studies in pregnant rats given oral gavage doses of pitavastatin at 0.1 mg/kg/day, 0.3 mg/kg/day, 1 mg/kg/day, 3 mg/kg/day, 10 mg/kg/day, 30 mg/kg/day from organogenesis through weaning (gestation day 17 to lactation day 21), maternal toxicity consisting of mortality at ≥ 0.3 mg/kg/day and impaired lactation at all doses contributed to the decreased survival of neonates in all dose groups (0.1 mg/kg/day represents approximately 1 time human systemic exposure at 4 mg/day dose based on auc). reproductive toxicity studies have shown that pitavastatin crosses the placenta in rats and is found in fetal tissues at ≤ 36% of maternal plasma concentrations following a single dose of 1 mg/kg/day during gestation (at the end of organogenesis). risk summary there is no available information about the presence of pitavastatin in human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. however, it has been shown that another drug in this class passes into human milk. statins, including pitavastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol and may cause harm to the breastfed infant. because of the potential for serious adverse reactions in a breastfed infant, based upon the mechanism of action, advise patients that breastfeeding is not recommended during treatment with zypitamag [see use in specific populations (8.1), clinical pharmacology (12.1)] . the safety and effectiveness of zypitamag in pediatric patients have not been established. pediatric use information is approved for kowa co ltd livalo (pitavastatin) tablets. however, due to kowa co ltd marketing exclusivity rights, this drug product is not labeled with that information. in controlled clinical studies, 1,209 (43%) patients were 65 years and older. no overall differences in safety or effectiveness were observed between these patients and younger patients. advanced age (≥ 65 years) is a risk factor for pitavastatin-associated myopathy and rhabdomyolysis. dose selection for a geriatric patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. monitor geriatric patients receiving zypitag for the increased risk of myopathy [see warnings and precautions (5.1)] . renal impairment is a risk factor for myopathy and rhabdomyolysis. monitor all patients with renal impairment for development of myopathy.  due to the risk of myopathy, a dosage modification of zypitamag is recommended for patients with moderate and severe renal impairment (estimated glomerular filtration rate 30 – 59 ml/min/1.73 m2 and 15 – 29 ml/min/1.73 m2 , respectively), as well as end-stage renal disease receiving hemodialysis [see dosage and administration (2.3), warnings and precautions (5.1), clinical pharmacology (12.3)] . zypitamag is contraindicated in patients with active liver failure or decompensated cirrhosis[see contraindications (4), warnings and precautions (5.3)] .

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

bayer ag - riociguat - hypertension, pulmonary - antihypertensives for pulmonary arterial hypertension - chronic thromboembolic pulmonary hypertension (cteph) adempas is indicated for the treatment of adult patients with who functional class (fc) ii to iii withinoperable cteph,persistent or recurrent cteph after surgical treatment,to improve exercise capacity. pulmonary arterial hypertension (pah) adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (pah) with who functional class (fc) ii to iii to improve exercise capacity. efficacy has been shown in a pah population including aetiologies of idiopathic or heritable pah or pah associated with connective tissue disease.

Avrupa Birliği - İngilizce - EMA (European Medicines Agency)

allergan pharmaceuticals ireland - bimatoprost, timolol - glaucoma, open-angle, ocular hypertension - ophthalmologicals, - reduction of intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.