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News FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl
The U.S. Food and Drug Administration (FDA) is informing the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines. |
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News GSK revises US Avandia label to include new restrictions on use
GlaxoSmithKline (GSK) announced revised US prescribing information and medication guides for all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl) to include additional safety information and restrictions on the use of these medicines. |
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News FDA significantly restricts access to the diabetes drug Avandia
The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. |
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News European Medicines Agency recommends suspension of Avandia, Avandamet and Avaglim
Anti-diabetes medication to be taken off the market |
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News CHMP meets to discuss Avandia and Pandemrix
The Committee for Medicinal Products for Human Use (CHMP) met on Wednesday 8 September to discuss the ongoing benefit-risk review of the rosiglitazone-containing medicines Avandia, Avandamet and Avaglim. |
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News CHMP meeting on 8 September 2010 to discuss Avandia and Pandemrix
The Committee for Medicinal Products for Human Use (CHMP) is meeting on Wednesday 8 September to discuss the ongoing benefit-risk review of the rosiglitazone-containing medicines Avandia, Avandamet and Avaglim. |
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News European Medicines Agency update on ongoing benefit-risk review of Avandia, Avandamet and Avaglim
Doctors reminded to follow current restrictions for rosiglitazone-containing anti-diabetes medicines until further notice |
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News GlaxoSmithKline statement in response to FDA Advisory Committees’ vote on safety of Avandia
GlaxoSmithKline [NYSE: GSK] confirmed that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow Avandia to remain on the market. |
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News GSK EU regulatory update on Avandia (rosiglitazone)
GlaxoSmithKline (GSK) confirmed that on behalf of the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) is to review the benefit/risk profile of Avandia (rosiglitazone). |
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Leaflet Drug Rosiglitazone (Oral Route)
Description: Rosiglitazone is used to treat high blood sugar levels that are caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. |
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Leaflet Drug Avandia
Description: Rosiglitazone is used to treat high blood sugar levels that are caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. |
