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Vertically integrated pharmaceutical
company in the Baltic States

Pharmacovigilance

Being responsible for drug and patient safety, JSC «Grindeks» develops drug adverse reaction monitoring (pharmacovigilance) in all countries, where our drugs are available. «Grindeks» and its subsidiary company «Kalceks» maintains single pharmacovigilance system.

Task of pharmacovigilance division is patient risk elimination, and detection of both positive and negative new effects.

Division is guided by Good Pharmacovigilance Practice and national legislation. Received information is verified, evaluated and reported when required.

If using or administering our drugs you notice side effect, lack of efficacy or other unusual reaction, please report it in the way most convenient for you

  • by using online form available further
  • by email: vigilance@grindeks.lv or marija.briede@grindeks.lv
  • by post: Pharmacovigilance division, JSC «Grindeks», Krustpils street 53, LV-1057, Riga, Latvia
  • by phone: +371 67083244 (business hours) or +371 22038854 (after business hours)

We guarantee full confidentiality of your data!

We also invite to report cases of inappropriate drug use!

If you want to report side effects on «Kalceks» drugs, we kindly advise you to use abovementioned options. More information on «Kalceks» products is available here.

 

Marija Briede
Qualified person for pharmacovigilance
Direct telephone number: +371 22038854

 

Download form (.doc).

 

 

 





PATIENT DETAILS *
Initials
Date of Birth or age
Sex
Female Male Do not want to specify
Age group
Child or adolescent Adult Elderly
Weight (kgs)
Height (cms)
REPORTER INFORMATION *
Please leave your mobile number (with country code) and email address to contact you if needed.
Reporters Name
Reporters Address
Institution
Phone No
Country
E-mail
Reporters qualification
Physician Pharmacist Consumer or Non-Health Care Professional Other Health Care Professional
Reported to regulatory authority?
Yes No
Initial Report
Follow-up Report
Date
SUSPECT DRUG(S) *
Brand name
Indication for use in the case
Lot No.
Exp. Date
Dose, Units, Frequency, Route Used
Start Date
Stop Date
Action taken with Suspect Drug
ADVERSE DRUG REACTION DESCRIPTION *
Diagnosis of ADR (s). If diagnosis is not known, provide symptom(s)
Start date
Stop date
Intensity
Mild Moderate Severe
Outcome
Did ADR improve after stopping or reducing drug?
Yes No Not available
Did AE reappear after reintroduction? Yes No Not available
RELEVANT INFORMATION ON ADVERSE DRUG REACTION
Please provide further relevant information on the ADR, treatment received, investigations and results
Do you consider that there is reasonable possibility that the reaction may have been caused by the Suspect Drug(s)?
Yes No Unknown
Reason
Was the case medically confirmed?
Yes No
SERIOUSNESS
Is ADR serious?
Yes No Unknown
Is the Adverse Event serious?
Post Mortem/ autopsy performed?
Yes No Unknown
RELEVANT MEDICAL HISTORY, CONCURRENT DISEASES
Please also include drug reactions, allergies, environmental factors and (or) drug & alchohol abuse
CONCOMITANT DRUG(S) (Exclude drugs used to treat the ADR)
Brand name
Indication
Daily dosage, units (x1/x2/x3/x4)
Frequency (x1/x2/x3/x4...)
Route
Start Date
Stop Date
 
* — mandatory fields