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Search results for "EMA EPAR" in comments (approximate match)
Status:
US Approved Rx
(1995)
Source:
BLA020280
(1995)
Source URL:
First approved in 1976
Class:
PROTEIN
Status:
US Approved Rx
(1996)
Source:
NDA020372
(1996)
Source URL:
First approved in 1973
Class:
PROTEIN
Conditions:
Molybdenum-99 (99Mo, half-life = 66 h) is a parent radionuclide of a diagnostic nuclear isotope. It decays in technetium-99 m (half-life = 6 h), which is used in over 30 million procedures per year around the world. Between 95 and 98 percent of Mo-99 is currently being produced using highly enriched uranium (HEU) targets. Other medical isotopes such as iodine-131 (I-131) and xenon-133 (Xe-133) are by-products of the Mo-99 production process and will be sufficiently available if Mo-99 is available.
Status:
US Approved Rx
(1996)
Source:
NDA020372
(1996)
Source URL:
First approved in 1973
Class:
PROTEIN
Conditions:
Molybdenum-99 (99Mo, half-life = 66 h) is a parent radionuclide of a diagnostic nuclear isotope. It decays in technetium-99 m (half-life = 6 h), which is used in over 30 million procedures per year around the world. Between 95 and 98 percent of Mo-99 is currently being produced using highly enriched uranium (HEU) targets. Other medical isotopes such as iodine-131 (I-131) and xenon-133 (Xe-133) are by-products of the Mo-99 production process and will be sufficiently available if Mo-99 is available.
Status:
US Previously Marketed
Source:
MACUGEN by BAUSCH AND LOMB INC
(2004)
Source URL:
First approved in 2004
Source:
MACUGEN by BAUSCH AND LOMB INC
Source URL:
Class:
NUCLEIC ACID
Conditions:
Pegaptanib is a selective vascular endothelial growth factor (VEGF) antagonist indicated for the treatment of neovascular (wet) age-related macular degeneration. Pegaptanib is an aptamer, a pegylated modified single-stranded oligonucleotide, which adopts a threedimensional conformation that enables it to bind to extracellular VEGF. Pegaptanib specifically binds to the 165 isoform of VEGF, a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two of the primary pathological processes responsible for the vision loss associated with neovascular age-related macular degeneration. Pegaptanib is administered in a 0.3 mg dose once every six weeks by intravitreal injection. An intravitreal injection is one that is administered directly into the eye, more specifically, into the vitreous humour, or the jelly-like fluid within the eye.
Status:
US Previously Marketed
Source:
VITRAVENE PRESERVATIVE FREE by NOVARTIS
(1998)
Source URL:
First approved in 1998
Source:
VITRAVENE PRESERVATIVE FREE by NOVARTIS
Source URL:
Class:
NUCLEIC ACID
Status:
US Approved Rx
(2016)
Source:
NDA208114
(2016)
Source URL:
First approved in 2016
Source:
NDA208114
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2018)
Source:
ANDA210464
(2018)
Source URL:
First approved in 1998
Source:
RENAGEL by GENZYME
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2018)
Source:
ANDA210464
(2018)
Source URL:
First approved in 1998
Source:
RENAGEL by GENZYME
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2003)
Source:
NDA021525
(2003)
Source URL:
First approved in 1995
Source:
NDA020451
Source URL:
Class:
POLYMER
Targets:
Conditions:
Porfimer is a photosensitizing agent used in the photodynamic therapy (PDT) of tumors. Porfimer sodium was approved under the brand name PHOTOFRIN for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy. For the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC). For the treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated. In addition, for the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy. The cytotoxic and antitumor actions of PHOTOFRIN® are light and oxygen dependent. Photodynamic therapy with Porfimer sodium is a two-stage process. The first stage is the intravenous injection of the drug, which mainly is concentrated in the tumor tissues for a longer period. Illumination with 630 nm wavelength laser light constitutes the second stage of therapy. Cellular damage is a consequence of the propagation of radical reactions. Radical initiation may occur after porfimer absorbs light to form a porphyrin excited state. Tumor death also occurs through ischemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release. The laser treatment induces a photochemical, not a thermal, effect. The necrotic reaction and associated inflammatory responses may evolve over several days.
Status:
Possibly Marketed Outside US
Source:
Cheon Shim Bo Hwa by Saimdang Cosmetics Co., Ltd
Source URL:
First approved in 1964
Source:
NADA012635
Source URL:
Class:
POLYMER
Conditions:
Tocophersolan (Vedrop, tocofersolan) or d-alpha-Tocopheryl Polyethylene Glycol 1000 Succinate (TPGS) is a watersoluble derivative of the natural active (d-alpha) isomer of vitamin E. The active constituent of the medicinal product is essentially vitamin E (alpha tocopherol). Chronic congenital or hereditary cholestasis is a clinical condition where vitamin E deficiency results from an impaired bile secretion. Decreased intestinal absorption observed in chronic congenital or hereditary cholestatic patients is due to decreased bile secretion and the resulting decrease in intestinal cellular absorption. As a result, fatsoluble vitamins (i.e. vit. E) are not absorbed properly and deficiency can occur. Tocophersolan (Vedrop) is used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Tocophersolan (Tocofersolan) can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin E deficiency. No treatment-related findings were reported, as all clinical observations and findings at autopsy were similar in treatment and control groups. In many of the studies, the LD50 was not
determined as tocofersolan was well tolerated.