Feedback form for experts – Nikopharm

Feedback form for experts

І. General information

5. Consequence of adverse reaction / lack of efficacy

8. Description of the adverse reaction / Indications of the lack of efficacy of the medicinal product (including the data of laboratory and instrumental studies concerning the adverse reaction)

9. Category of adverse reaction / lack of efficacy

ІІ. Information on suspected drug (SD), SD manufacturer

ІІІ. Information on concomitant drugs (with the exception of drugs that have been used to correct the effects of adverse reactions)

19. Concomitant drugs (trade name, dosage form, manufacturer)

26. Other important information (diagnoses, allergies, pregnancy with duration, etc.)

ІV. Means of correction of an adverse reaction

Was the SD canceled with the disappearance of adverse reaction?

Has the resumption of an adverse reaction been noted after re-appointment of the SD?

Has an update of the adverse reaction been noted after dosing SD?

V. Information about the notifier

28. Notification provides

29. The name and location of the health care institution or the applicant of the disease / ambulatory card

30. Source of notification (paragraph 30-32 only for the applicant)

33. Type of notification

To consumersTo specialists To partners
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