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Search results for clopidogrel in EMA ASSESSMENT REPORTS (approximate match)
Showing 1 - 6 of 6 results
Status:
US Approved Rx
(2014)
Source:
ANDA204165
(2014)
Source URL:
First approved in 1997
Source:
NDA020839
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Clopidogrel, an antiplatelet agent structurally and pharmacologically similar to ticlopidine, is used to inhibit blood clots in a variety of conditions such as peripheral vascular disease, coronary artery disease, and cerebrovascular disease. Clopidogrel is sold under the name Plavix by Sanofi and Bristol-Myers Squibb. Plavix (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct
inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADPmediated
activation of the glycoprotein GPIIb/IIIa complex. Clopidogrel must be metabolized by CYP450 enzymes to produce the active metabolite that
inhibits platelet aggregation. The active metabolite of clopidogrel selectively inhibits the
binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADPmediated
activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet
aggregation. This action is irreversible. Consequently, platelets exposed to clopidogrel’s active
metabolite are affected for the remainder of their lifespan (about 7 to 10 days). Platelet
aggregation induced by agonists other than ADP is also inhibited by blocking the amplification
of platelet activation by released ADP. Plavix (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events.
Status:
US Approved Rx
(2014)
Source:
ANDA204165
(2014)
Source URL:
First approved in 1997
Source:
NDA020839
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Clopidogrel, an antiplatelet agent structurally and pharmacologically similar to ticlopidine, is used to inhibit blood clots in a variety of conditions such as peripheral vascular disease, coronary artery disease, and cerebrovascular disease. Clopidogrel is sold under the name Plavix by Sanofi and Bristol-Myers Squibb. Plavix (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct
inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADPmediated
activation of the glycoprotein GPIIb/IIIa complex. Clopidogrel must be metabolized by CYP450 enzymes to produce the active metabolite that
inhibits platelet aggregation. The active metabolite of clopidogrel selectively inhibits the
binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADPmediated
activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet
aggregation. This action is irreversible. Consequently, platelets exposed to clopidogrel’s active
metabolite are affected for the remainder of their lifespan (about 7 to 10 days). Platelet
aggregation induced by agonists other than ADP is also inhibited by blocking the amplification
of platelet activation by released ADP. Plavix (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events.
Status:
US Approved Rx
(2014)
Source:
ANDA204165
(2014)
Source URL:
First approved in 1997
Source:
NDA020839
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Clopidogrel, an antiplatelet agent structurally and pharmacologically similar to ticlopidine, is used to inhibit blood clots in a variety of conditions such as peripheral vascular disease, coronary artery disease, and cerebrovascular disease. Clopidogrel is sold under the name Plavix by Sanofi and Bristol-Myers Squibb. Plavix (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct
inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADPmediated
activation of the glycoprotein GPIIb/IIIa complex. Clopidogrel must be metabolized by CYP450 enzymes to produce the active metabolite that
inhibits platelet aggregation. The active metabolite of clopidogrel selectively inhibits the
binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADPmediated
activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet
aggregation. This action is irreversible. Consequently, platelets exposed to clopidogrel’s active
metabolite are affected for the remainder of their lifespan (about 7 to 10 days). Platelet
aggregation induced by agonists other than ADP is also inhibited by blocking the amplification
of platelet activation by released ADP. Plavix (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events.
Status:
US Approved Rx
(2014)
Source:
ANDA204165
(2014)
Source URL:
First approved in 1997
Source:
NDA020839
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Clopidogrel, an antiplatelet agent structurally and pharmacologically similar to ticlopidine, is used to inhibit blood clots in a variety of conditions such as peripheral vascular disease, coronary artery disease, and cerebrovascular disease. Clopidogrel is sold under the name Plavix by Sanofi and Bristol-Myers Squibb. Plavix (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct
inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADPmediated
activation of the glycoprotein GPIIb/IIIa complex. Clopidogrel must be metabolized by CYP450 enzymes to produce the active metabolite that
inhibits platelet aggregation. The active metabolite of clopidogrel selectively inhibits the
binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADPmediated
activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet
aggregation. This action is irreversible. Consequently, platelets exposed to clopidogrel’s active
metabolite are affected for the remainder of their lifespan (about 7 to 10 days). Platelet
aggregation induced by agonists other than ADP is also inhibited by blocking the amplification
of platelet activation by released ADP. Plavix (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events.
Status:
US Approved Rx
(2014)
Source:
ANDA204165
(2014)
Source URL:
First approved in 1997
Source:
NDA020839
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Clopidogrel, an antiplatelet agent structurally and pharmacologically similar to ticlopidine, is used to inhibit blood clots in a variety of conditions such as peripheral vascular disease, coronary artery disease, and cerebrovascular disease. Clopidogrel is sold under the name Plavix by Sanofi and Bristol-Myers Squibb. Plavix (clopidogrel bisulfate) is an inhibitor of ADP-induced platelet aggregation acting by direct
inhibition of adenosine diphosphate (ADP) binding to its receptor and of the subsequent ADPmediated
activation of the glycoprotein GPIIb/IIIa complex. Clopidogrel must be metabolized by CYP450 enzymes to produce the active metabolite that
inhibits platelet aggregation. The active metabolite of clopidogrel selectively inhibits the
binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADPmediated
activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet
aggregation. This action is irreversible. Consequently, platelets exposed to clopidogrel’s active
metabolite are affected for the remainder of their lifespan (about 7 to 10 days). Platelet
aggregation induced by agonists other than ADP is also inhibited by blocking the amplification
of platelet activation by released ADP. Plavix (clopidogrel bisulfate) is indicated for the reduction of atherothrombotic events.
Status:
US Approved OTC
Source:
21 CFR 343.13(b) internal analgesic:rheumatologic aspirin (buffered)
Source URL:
First marketed in 1899
Source:
Aspirin by Friedr. Bayer & Co., Elberfeld, Germany
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Aspirin is a nonsteroidal anti-inflammatory drug. Aspirin is unique in this class of drugs because it irreversibly inhibits both COX-1 and COX-2 activity by acetylating a serine residue (Ser529 and Ser516, respectively) positioned in the arachidonic acid-binding channel, thus inhibiting the synthesis of prostaglandins and reducing the inflammatory response. The drug is used either alone or in combination with other compounds for the treatment of pain, headache, as well as for reducing the risk of stroke and heart attacks in patients with brain ischemia and cardiovascular diseases.