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Search results for "EMA VET. EPAR" in comments (approximate match)
Status:
Possibly Marketed Outside US
First approved in 2012
Source:
NADA141320
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Robenacoxib (trade name Onsior) is a non-steroidal anti-inflammatory drug (NSAID) used in veterinary medicine for the relief of pain and inflammation in cats and dogs. In an inflammation model in cats, Robenacoxib had analgesic, anti-inflammatory and antipyretic actions with a rapid onset of action (0.5 h). In an in vitro whole blood assay in cats, Robenacoxib demonstrated selective COX-2 inhibition. After oral administration of robenacoxib tablets at 1 mg/kg without food, peak blood concentrations are attained rapidly with a median Tmax of 0.5 h, a mean Cmax of 1159 ng/ml and a mean AUC of 1337 ng*h/ml. Robenacoxib persists longer in the inflammatory exudate of a tissue cage model than in blood. The median Robenacoxib elimination half-life in exudate was about 27 hours versus 2.5 hours for blood. Robenacoxib is extensively metabolized by the liver in cats. The systemic exposure of lactam metabolite is about 25% of Robenacoxib exposure following oral administration to fed cats. Further, the systemic exposure to lactam appears to be two-fold greater in fed cats than fasted cats. Apart from one lactam metabolite, the identity of other metabolites is not known in cats.
Status:
Possibly Marketed Outside US
First approved in 2011
Source:
NADA141328
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Gamithromycin, the active pharmaceutical ingredient of ZACTRAN is a novel 7a-azalide that has been developed for treatment and prevention of bovine respiratory disease (BRD). The compound belongs to the 15-membered semi-synthetic macrolide antibiotics of the azalide sub-class with a uniquely positioned alkylated nitrogen at the 7a-position of the lactone ring. Macrolide antibiotics in general have bacteriostatic action by inhibiting bacterial RNA dependent protein biosynthesis, but can also be bactericidal. They reversibly bind to 23S ribosomal RNA in the 50S-subunit of prokaryotic ribosomes and prevent protein elongation during the translocation process. In vitro data show that gamithromycin has both bactericidal and bacteriostatic actions at least at the higher concentrations found in lung tissue. The broad spectrum antimicrobial activity of gamithromycin includes Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, the bacterial pathogens most commonly associated with BRD. Gamithromycin administered subcutaneously is well absorbed and fully bioavailable, and safe for the target animal receiving doses up to five times the recommended dose at 30 mg ⁄ kg body weight. Following s.c. administration, gamithromycin is extensively and rapidly distributed to lung tissue, the site of respiratory infection.
Status:
Possibly Marketed Outside US
First approved in 2009
Source:
NADA141295
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Toceranib (toceranib phosphate) is an orally bioavailable small molecule inhibitor that blocks a variety of RTKs, including VEGFR2, PDGFRa and KIT. In non-clinical pharmacology studies, toceranib selectively inhibited the tyrosine kinase activity of several members of the split kinase receptor tyrosine kinase (RTK) family, some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. Toceranib inhibited the activity of Flk-1/KDR tyrosine kinase (vascular endothelial growth factor receptor, VEGFR2), platelet-derived growth factor receptor (PDGFR), and stem cell factor receptor (Kit) in both biochemical and cellular assays. Toceranib has been shown to exert an antiproliferative effect on endothelial cells in vitro. Toceranib treatment can induce cell cycle arrest and subsequent apoptosis in tumor cell lines expressing activating mutations in the split kinase RTK, ckit. Canine mast cell tumor growth is frequently driven by activating mutations in c-kit. Toceranib is a dog-specific anti-cancer drug approved by the U.S. Food and Drug Administration. It is marketed as Palladia as its phosphate salt, toceranib phosphate by Pfizer. PALLADIA (Toceranib) tablets are indicated for the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs.
Status:
Possibly Marketed Outside US
First approved in 2008
Source:
NADA141285
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Cefovecin is a third generation cephalosporin with a broad-spectrum of activity against Gram-positive and Gram-negative bacteria. Cefovecin differs from other cephalosporins in that it is highly protein bound and has a long duration of activity. As with all cephalosporins, the bactericidal action of cefovecin results from the inhibition of bacterial cell wall synthesis through binding to the penicillin-binding proteins (PBPs). It is indicated for the treatment of skin infections secondary superficial pyoderma, abscesses and wounds. Some gastrointestinal adverse effects like vomiting, anorexia or diarrhea were observed.
Status:
Possibly Marketed Outside US
First approved in 2007
Source:
NADA141275
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Emodepside is a semi-synthetic product (originated by Astellas and out-licensed to Bayer for animal and human use); its precursor is synthesized by a fungus living in the leaves of Camellia japonica. It is a potent antihelminthic drug used in combination with praziquantel (as Profender®) and in combination with toltrazuril (as Procox®) for the treatment of parasitic worms in cats and dogs. Emodepside, a semi-synthetic derivative of PF1022A, belongs to a new class of anthelmintic drugs, the cyclooctadepsipeptides, and shows good efficacy against macrocyclic lactone-, levamisole- or benzimidazole-resistant nematode populations. Although putative receptors for emodepside have already been discovered, its mode of action is still not fully understood. It has being suggested that GABA(A)-receptor UNC-49 is associated with the emodepside mode of action. It has also being shown that Emodepside binds to a presynaptic latrophilin receptor in nematodes. The following presynaptic signal transduction occurs via activation of Gqalpha protein and phospholipase-Cbeta, which leads to mobilization of diacylglycerol (DAG). DAG then activates UNC-13 and synaptobrevin, two proteins which play an important role in presynaptic vesicle-functioning. This finally leads to the release of a currently unidentified transmitter. The transmitter (or modulator) exerts its effects at the postsynaptic membrane and induces a flaccid paralysis of the pharynx and the somatic musculature in nematodes.
Status:
Possibly Marketed Outside US
First approved in 2007
Source:
NADA141273
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Pimobendan (INN, or pimobendane; tradenames Vetmedin, Acardi, and Heartmedin) is a veterinary medication. Under the trade name Acardi, it is available for human use in Japan. Usually, this medicine is used to treat acute heart failure and chronic heart failure (mild to moderate in severity). By increasing the calcium ion sensitivity to protein regulating myocardial contraction and also by inhibiting phosphodiesterase (PDE-III) activity, this medicine dilates the blood vessels and improves the symptoms of heart failure such as shortness of breath and difficulty in breathing. Pimobendan is metabolized into an active metabolite (desmethylpimobendan) by the liver. The parent compound, pimobendan, is a potent calcium sensitizer while desmethylpimobendan is a more potent phosphodiesterase III inhibitor. Pimobendan is 90–95% bound to plasma proteins in circulation. This may have implications in patients suffering from low blood protein levels (hypoproteinemia/hypoalbuminemia) and in patients that are on concurrent therapies that are also highly protein bound.
Status:
Possibly Marketed Outside US
Source:
Advantage® DUO by Nihon Tokushu Noyaku Seizo K. K.
Source URL:
First approved in 2006
Source:
NADA141251
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Imidacloprid is a systemic, chloro-nicotinyl insecticide used for the control of sucking insects such as fleas, aphids, whiteflies, termites, turf insects, soil insects, and some beetles. It is used on co on and vegetable crops as foliar and seed treatments, soil, structures, indoor and outdoor insect control, home gardening and pet products. It is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. It kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis). It is also indicated for the treatment and control of the following intestinal parasites Hookworm species, Roundworm species, Whipworms. Adverse events in animals included: malaise, vomiting, diarrhea, shaking, mydriasis, hypersalivation with abnormal neurologic signs, seizures, death, generalized hematoma of the body, and alopecia at the treatment site. Adverse reactions in humans included: burning, tingling, numbness, bad taste in the mouth, dizziness, and headache.
Status:
Possibly Marketed Outside US
First approved in 2004
Source:
NADA141230
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Firocoxib is a selective COX-2 inhibitor which was approved by FDA and EMEA for the treatment of osteoarthritis and postoperative pain in dogs (Previcox trade name) and horses (Equioxx trade name). The drug is not for human use.
Status:
Possibly Marketed Outside US
Source:
Econor by Novartis
Source URL:
First approved in 2001
Source:
Valnemulin Hydrochloride by Chemo Biosynthesis s.r.l.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Valnemulin (marketed under the trade name Econor) is a pleuromutilin antibiotic used to treat swine dysentery, ileitis, colitis and pneumonia. It is approved for veterinary use only. Valnemulin is an antibiotic belonging to the pleuromutilin group, which acts by the inhibition of the initiation of protein synthesis at the level of the bacterial ribosome. Valnemulin has activity against a range of bacteria including those responsible for enteric and respiratory disease in pigs. Valnemulin shows high activity against Mycoplasma spp. and spirochaetes such as Brachyspira hyodysenteriae and Brachyspira pilosicoli. Valnemulin has little activity against Enterobacteriaceae, such as Salmonella spp. and Escherichia coli. There appears to be no resistance development to valnemulin to date by M. hyopneumoniae and L. intracellularis. There have been some increases of MICs of valnemulin against B. hyodysenteriae and to a lesser degree B. pilosicoli, some of which appear to have developed resistance. Valnemulin binds to the ribosome and inhibits bacterial protein synthesis. Resistance development primarily occurs because of changes at the binding site associated with mutations of the ribosomal DNA genes. Econor 10% and 50% is indicated for: The treatment and prevention of swine dysentery. The treatment of clinical signs of porcine proliferative enteropathy (ileitis). The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd. Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10 - 12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated. Econor 0.5% and 1% is indicated: For the treatment and prevention of swine dysentery. The treatment of clinical signs of porcine proliferative enteropathy (ileitis). The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd.
Status:
Possibly Marketed Outside US
First approved in 2000
Source:
NADA141036
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Pirlimycin is an antibiotic which was approved in the US and Europe for the treatment of subclinical mastitis in lactating dairy cattle associated with common mastitis pathogens, mostly Gram-positive bacterias. The drug exerts its action by binding to the 50S ribosomal subunit, therefore hindering the aminoacyl-tRNA binding and inhibiting the peptidyltransferase reaction, which interferes with protein synthesis within the bacteria.