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Search results for "EMA EPAR|DISEASES" in comments (approximate match)
Status:
US Approved Rx
(2000)
Source:
NDA021119
(2000)
Source URL:
First approved in 2000
Source:
NDA021119
Source URL:
Class:
MIXTURE
Conditions:
Verteporfin (trade name Visudyne), a benzoporphyrin derivative, is a medication used for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis syndrome. Verteporfin can also be used to destroy tumors. Verteporfin is a 1:1 mixture of two regioisomers (I and II), VISUDYNE therapy is a two-stage process requiring administration of both verteporfin for injection and nonthermal red light. Verteporfin accumulates in these abnormal blood vessels and, when stimulated by nonthermal red light with a wavelength of 689 nm in the presence of oxygen, produces highly reactive short-lived singlet oxygen and other reactive oxygen radicals, resulting in local damage to the endothelium and blockage of the vessels. Verteporfin is also used off-label for the treatment of central serous retinopathy. Verteporfin is given intravenously, 15 minutes before laser treatment. Light activation of verteporfin results in local damage to neovascular endothelium, resulting in vessel occlusion. Damaged endothelium is known to release procoagulant and vasoactive factors through the lipo-oxygenase (leukotriene) and cyclo-oxygenase (eicosanoids such as thromboxane) pathways, resulting in platelet aggregation, fibrin clot formation and vasoconstriction. Verteporfin appears to somewhat preferentially accumulate in neovasculature, including choroidal neovasculature. However, animal models indicate that the drug is also present in the retina. Therefore, there may be collateral damage to retinal structures following photoactivation including the retinal pigmented epithelium and outer nuclear layer of the retina. The temporary occlusion of choroidal neovascularization (CNV) following VISUDYNE therapy has been confirmed in humans by fluorescein angiography.
Status:
US Approved Rx
(2020)
Source:
BLA761146
(2020)
Source URL:
First approved in 1965
Source:
BLA101995
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(1956)
Source:
NDA010402
(1956)
Source URL:
First approved in 1942
Source:
NDA004782
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
NCT03177538: Phase 4 Interventional Completed Infertility, Female
(2017)
Source URL:
First approved in 2005
Source:
PLUSET by Minitube of America, Inc.
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2015)
Source:
BLA125511
(2015)
Source URL:
First approved in 2015
Source:
BLA125511
Source URL:
Class:
PROTEIN
Parathyroid hormone (PTH) is an 84-amino acid peptide that regulates the function of osteoblasts and osteocytes and is secreted by the parathyroid gland in response to changes in the concentration of extracellular calcium. Parathyroid hormone is approved under the brand name NATPARA as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. It is also available for treatment of postmenopausal osteoporosis in many European countries. Parathyroid hormone is an activator of parathyroid hormone 2 receptor. In addition, was shown, that downregulation of Notch in osteoblasts and osteocytes may represent a mechanism contributing to the anabolic effects of parathyroid hormone in bone.
Status:
US Approved Rx
(2015)
Source:
BLA125516
(2015)
Source URL:
First approved in 2015
Source:
BLA125516
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2023)
Source:
BLA761349
(2023)
Source URL:
First approved in 2015
Source:
BLA125504
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2015)
Source:
BLA125526
(2015)
Source URL:
First approved in 2015
Source:
BLA125526
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2015)
Source:
BLA761035
(2015)
Source URL:
First approved in 2015
Source:
BLA761035
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2020)
Source:
BLA761145
(2020)
Source URL:
First approved in 2015
Source:
BLA761036
Source URL:
Class:
PROTEIN