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.

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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 means a response to a drug which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function and is characterized by the suspicion of a causal relationship between a medical product and an occurrence;

Examples of Adverse Drug Reaction in a sentence

The parties agree to develop and commit to a Safety Data Exchange Agreement (“SDEA”) that allows them to fulfill their respective regulatory and pharmacovigilence obligations relating to Adverse Drug Event and Adverse Drug Reaction reporting.
Once an Adverse Event or a Suspected Adverse Drug Reaction has been identified, Shire will assess it according to seriousness and where appropriate report it as a literature report quoting the reference for the article for onward reporting to the appropriate Regulatory Authority in the Territory.
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.
Within 90 days after the Effective Date, the Parties shall begin to negotiate in good faith a process and procedures for sharing Adverse Drug Reaction and Serious Adverse Drug Reaction information which shall be documented in a pharmacovigilance agreement with respect to the Licensed Product (the “Pharmacovigilance Agreement”).
Submit a Report of Adverse Drug Reaction to the TB Branch Nurse Case Manager Consultant (or designee), if a TB Suspect or Case dies or is hospitalized due to an adverse drug reaction (refer to TB Work Plan, Section X).

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 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

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 an unexpected and untoward reaction to medication.

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 a noxious and unintended response to a medicine;

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: