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The information you provide us is extremely important to detect unknown adverse reactions to medicinal products authorized for use on the territory of the Republic of Bulgaria. We will need your contact details in order to feedback to confirm receipt of the message; If we need to request additional information and to inform you of the measures taken. We assure you that the personal data of reporter / patient is treated in accordance with the Law on Personal Data Protection. The BDA is registered as a data controller under the law. Certificate №0026870.

 

Please notice that some fields marked with (*) are mandatory to fill in order to submit a valid report form. Nevertheless we would like to encourage you to provide as much information as possible, because it is important for the assessment of your report.

Reporter type: Patient (Consumer) Parent Other non-healthcare professional

REPORTER DETAILS

 

CONTACT DETAILS

* Please provide contact details by completing at least one of the fields in order to submit a valid report; preferably - phone number.

 
Telephone: :: Digits ONLY!
 
E-mail: :: Please enter a valid e-mail address or leave this field blank.
 

PATIENT DETAILS

* Complete at least one of the fields to be accepted as a valid report.

Gender: Male Female
years
Age: :: Fill in the age of the patient (numbers only and/or decimal point, eg.: 1.6 for a patient aged one year and a half).
 
kg
Weight: :: Fill in the patient`s weight in kilograms (only numbers and / or decimal point, eg.: 79.5 for patients who weighs 79 kg and a half).
cm
Height: :: Enter the stature of the patient in centimeters (numbers only and/or decimal point, eg.: 80.5 cm).
 

SUSPECT DRUG DETAILS

 
Additional data:

1. Drug formulation (e.g. tablets), dose unit (e.g. 250 mg):

2. Pharmaceutical company - marketing authorization holder:

3. Batch number:

4. Reason for taking the drug:

5. Dose regimen. When (at what time), how many times per day; per hour; per week?

 

7. End date:

The administration was terminated on:
 
The administration has not been terminated yet
 

Additional information about the medicinal product:

Other drugs taken during the adverse reaction:

Other drugs taken during the adverse reaction: :: Please describe any other medicines you applied at the time of the reaction and the month before that, including medications, purchased without a prescription, or dietary supplements.

SUSPECTED ADVERSE DRUG REACTION DETAILS

 
* Adverse drug reaction details: :: Please describe the observed adverse reaction of the patient.
Additional data:
 
 
3. Please select an outcome of the adverse drug reaction:
  • recovered
  • recovered with sequels
  • recovering
  • adverse drug effect continues
  • fatal
  • unknown
  • other
4. Please describe to what extent the adverse drug reaction affected your daily activities:
  • slightly uncomfortable
  • caused disablement
  • admitted to hospital
  • life threatening
  • caused invalidism
  • other
5. Possible cause for the reaction
 
Yes » Explanation:
» Explanation: :: Please explain the reason caused the adverse drug reaction: unintentional mistake in the prescription, dosing, dispensing or administration of the medication.

No
 
 

  
* Anti-spam code: :: Please fill in the blank with the generated symbols.
 
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