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The document provides prescribing information for VUMERITY™ (diroximel fumarate), a medication approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults. It outlines important warnings and precautions, including risks of serious infections like progressive multifocal leukoencephalopathy (PML) and herpes zoster, as well as potential adverse reactions such as flushing, abdominal pain, diarrhea, and nausea. The document details dosage instructions, contraindications, necessary blood tests prior to and during treatment, and specific population considerations such as pregnancy and renal impairment.

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What is the dealer member rule 3300?

Under the Investment Industry Regulatory Organization of Canada Dealer Member Rule 3300, best execution is defined as obtaining the most advantageous execution terms reasonably available under the circumstances.

What is the difference between on label and off-label drugs?

Off-label use of drugs and devices is legal, and provided it is based in sound medical evidence, it appears to have similar safety to on-label use. However, most off-label use, at least of drugs, is not based on strong medical evidence, poses serious risks to patients, and requires careful consideration.

What is on the label of a prescription drug?

The label on your prescription medication tells you how to correctly take the medicine your healthcare provider has recommended for your treatment plan. Its very important to understand the information on this label. By taking your medication correctly, you will have the best treatment results.

What is the minimum capital requirement for IIROC?

An applicant must have minimum capital of $250,000 (unless applying as a Type 1 Introducing Broker for which the minimum capital is $75,000). These are minimum capital levels only and a sufficient amount of operating capital for the applicants business activities must also be provided.

What is the PLR rule?

A private letter ruling (PLR) is a written decision by the Internal Revenue Service (IRS) that is sent in response to a taxpayers request for guidance on unusual circumstances or complex questions about their specific tax situation. For certain transactions involving large amounts of money, the tax law may be unclear.

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What describes off-label prescribing?

Off-label drug use refers to the practice of prescribing a drug for a different purpose than what the FDA approved. This practice is called off-label because the drug is being used in a way not described on its package insert.

What is the PLR rule book?

The PLR Rule Book contains specific rules Dealer Members must follow as a condition of their IIROC membership. As registrants, Dealer Members must also comply with Canadian securities laws, including NI 31-103.

What is the rule 18.15 for IIROC?

The proposed provision is consistent with current IIROC Dealer Member Rule 18.15 which states that a Registered Representative or Investment Representative may not accept or permit any associate to accept, directly or indirectly, any remuneration, gratuity, benefit or any other consideration from any person other than

What is the physician labeling rule?

The Physician Labeling Rule states that a drug labeled as category A poses no risk to the fetus in the first trimester. When a drug has a category A label, it means that studies performed on pregnant human women did not demonstrate any risk for fetal abnormalities.

What does on label mean in pharma?

On-label use means the drug is being used in the same indication, dose, route of administration, patient populations, and drug formulation. There is no deviation from the approved FDA label.