The Medical Letter Online

Archive for June, 2012

Launch Notice

| June 30, 2012 | 0 Comments

Announce regarding the launch of Phase II of the Summary Basis of Decision project. This project is part of HPFB’s ongoing commitments to enhance the transparency of the pharmaceutical, biologic and medical device regulatory review processes, and to provide access to information about Health Canada’s decisions to authorize these products for sale in Canada. Health [...]

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Committee for Advanced Therapies (CAT): 14-15 June 2012, European Medicines Agency, London, UK, From: 14-Jun-2012, To: 15-Jun-2012

| June 30, 2012 | 0 Comments

The Committee for Advanced Therapies (CAT) is the committee that is responsible for assessing the quality, safety and efficacy of advanced-therapy medicines. It does not currently publish the minutes or agendas of its meetings. It does publish a meeting report after each meeting. Meetings and events

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AMNESTEEM (Isotretinoin) Capsule [Physicians Total Care, Inc.]

| June 30, 2012 | 0 Comments

Updated Date: Jun 25, 2012 EST DailyMed Drug Label Updates for the last seven days (since Jun 23, 2012 EST)

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Current Drug Shortages: Isoniazid Tablets (updated)

| June 30, 2012 | 0 Comments

Manufacturing delays. FDA Drug Shortages

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Cataplex ACP, Cataplex C, and Pancreatrophin PMG Dietary Supplements: Recall – Potential for Contamination With Salmonella

| June 30, 2012 | 0 Comments

Risk of serious and sometimes fatal infections, especially in young children, frail or elderly people, and others with weakened immune systems. MedWatch Safety Alert RSS Feed

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Harper Government Working with Ontario First Nations to Address Prescription Drug Abuse

| June 30, 2012 | 0 Comments

The Honourable Leona Aglukkaq, Minister of Health, today announced funding to address prescription drug abuse in First Nations communities in Ontario. This investment will focus on service provision and continuum of care; integration of services and enhanced collaboration among service providers; and capacity building, training and education. Health Canada RSS – Media Room

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Listeria Contamination in Queso Fresco, Fresh Cheese

| June 30, 2012 | 0 Comments

Queso Fresco Cheese Food and Drug Administration–Recalls/Safety Alerts

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FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)

| June 29, 2012 | 0 Comments

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that preliminary results from a recently completed clinical study suggest that a 32 mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop [...]

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Human medicines European Public Assessment Report (EPAR): Matever, levetiracetam, Revision: 3, Authorised

| June 29, 2012 | 0 Comments

Pending EC decisions and European Public Assessment Reports (EPARs): Human medicinal products

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“ZXT Gold” Bee Pollen Capsules Found to Contain Hidden Drugs, May Pose Serious Health Risks

| June 29, 2012 | 0 Comments

Health Canada testing has identified that the weight loss product “ZXT Gold” bee pollen capsules contain hidden pharmaceutical ingredients (sibutramine and phenolphthlalein), which may pose serious health risks. Health Canada RSS – MedEffect Canada – Advisories and Recalls for the Public

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