CHOLUDEXAN

CHOLUDEXAN

A prescription drug used for diseases of the liver and biliary tract, in biliary pathology. Ursodeoxycholic acid (UDCA).

Capsules

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CARD-NOTIFICATION OF AN ADVERSE DRUG REACTION AND/OR LACK OF EFFICACY OF THE MEDICINE

INFORMATION ABOUT THE PATIENT

SUSPECTED AR/LE

Suspected AR (describe each clinical manifestation of the AR with dates and times of onset and end and outcome)/Indication of the LE

INFORMATION ABOUT SUSPECTED MEDICINES

INFORMATION ABOUT RELATED MEDICINES

(with the exception of drugs used to correct the effects of AR/LE)
(concomitant diagnoses, laboratory and instrumental studies, allergy history, pregnancy with gestational age, method of conception, pregnancy outcome (if the pregnancy ended, the date of delivery, type of delivery, etc.)

Information about the messenger

INFORMATION ABOUT THE MEDICAL/PHARMACY SPECIALIST

(if not the notifier)

MESSAGE CARD for the patient

to provide the patient and/or his/her representative with information on adverse drug reactions and/or lack of efficacy of the drug

INFORMATION ABOUT THE PATIENT

Information about the suspected medicine

Information on the prescription of the suspected medicinal product

Information about the messenger

Information about the physician, healthcare facility and place of residence of the patient who had an adverse medicine reaction and/or lack of efficacy of the medicine

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