Adverse drug reaction definition

Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

Adverse drug reaction means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment, or prevention of a disease or the modification of an organic function.

Adverse drug reaction or “adverse reaction” means a response to a medicine in humans which is noxious and unintended, including lack of efficacy, and which occurs at doses normally used in man and which can also result from overdose, misuse or abuse of a medicine

Examples of Adverse drug reaction in a sentence

• Adverse Reaction/ Adverse Drug Reaction (ADR) A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function.

• AR Adverse Drug Reaction — First occurrence of an adverse reaction by a patient to a drug.

• Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.

• In this regard, Xxxxx agrees to notify Cantel Canada within forty-eight (48) hours of the occurrence of any event identified in the Canada Vigilance Program (formerly known as the Canadian Adverse Drug Reaction Monitoring Program) imposing a reporting obligation on Buyer and/or Cantel Canada.

• Each Party shall advise the other as promptly as reasonably practical by telefax or overnight delivery service addressed to the attention of its Vice President, Regulatory Affairs (or equivalent), of any Adverse Drug Reaction that has been brought to that Party’s attention at any place and that is alleged to be related to administration of any Product.

More Definitions of Adverse drug reaction

Adverse drug reaction or “ADR” means a response to any Licensed Product or Demonstration Sample which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modification of physiological function.

Adverse drug reaction means an unexpected and untoward reaction to medication.

Adverse drug reaction has the meaning as defined in the then-current guidelines and regulations promulgated by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and shall include any “Adverse Drug Experience” as defined in the then-current 21 CFR Section 314.80.

Adverse drug reaction means a harmful and unintended response by a resident to a drug or combination of drugs which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; (“réaction indésirable à un médicament”)

Adverse drug reaction means an adverse physical or psychological reaction that is experienced by a person resulting from diagnostic therapeutic agents administered by an optometrist and that occurs within 24 hours after the drug is administered. An adverse drug reaction may be indicated by symptoms that include any of the following:

Adverse drug reaction means any unexpected, unintended, undesired or excessive response to a drug such that it:

Adverse drug reaction means any noxious and unintended response to a drug that is caused by the administration of any dose of the drug. (réaction indésirable à une drogue)