We as marketing authorization holders assume responsibility for safety monitoring of our drugs. Therefore, we kindly ask that you report any observed adverse drug reactions, as well as any shortcomings in drug efficacy to the JSC Olainfarm Pharmacovigilance Group.
We invite you to complete the english language forms of “Report on Adverse Drug Reactions” (Report) prepared by JSC “Olainfarm”:
A PDF document is provided, if you wish to print the form out, complete it handwritten and send it to us by fax +371 67013777 or by mail: JSC Olainfarm, Pharmacovigilance Group, Rupnicu street 5, Olaine, Latvia, LV-2114.
About the serious and unexpected adverse drug reactions we invite you to report to us immediately or on the following day by phone: +371 67013724 or +371 26137761 (24/7 mobile phone), as well as by sending a Report as soon as possible, as instructed above. Please also report on other adverse drug reactions as soon as possible! Upon receipt of your report, we will notify you and, if needed, we will ask you for further details in order to specify the details of the information that you have provided.
The data in Report form shall completely describe the observed adverse drug reaction, as well as provide information on the patient and his or her medical history. When describing the medicines taken by the patient, please also mention the active substance and characteristics of these medicines (e.g., prolonged activity drugs). Only accurate and detailed information will enable us to analyse and identify adverse drug reactions and their causal relationship with concurrently administered medicines. We will be grateful if you add an extract from a hospital or outpatient card, without mentioning the name, personal ID, and address of the patient. Please provide only the initials of the patient.
The latest SAM information on the safety of drug use is available here.
You can also get help from the Pharmacists’ Society of Latvia: //www.farmaceitubiedriba.lv/en.
The latest information for healthcare professionals prepared by European Medicines Agency you can find here.