Olpha’s
Pharmaco-
vigilance

Our operating basic principle is to produce reliable and efficient top quality products, therefore every Olpha product is thoroughly tested and traced in different stages of its life cycle.

Our Pharmacovigilance Division ensures the monitoring of side adverse reactions of medicinal products to ensure safe use of medicinal products for which we are marketing authorisation holders on the market as well as for medicinal products under ongoing clinical trials and studies.

Pharmacovigilance responsibilities

Pharmacovigilance Group’s authorities and actions

Identification of new potential risks that may affect drug safety and efficacy of the medicinal products

Evaluation of the risk-benefit balance of medicinal product use

Analysis of the information received from drug safety monitoring

Providing actual safety information regarding medicinal product use to Regulatory Authorities, health care providers, patients, contractual partners, company employees

Reporting

Reporting on side effects

Healthcare professionals, patients, their relatives, any other interested persons can and are welcomed to report on Olpha medicinal products’ side effects (adverse reactions).

You can choose by yourself to whom you will send the report – directly to your local Regulatory Authority or to our local pharmacovigilance responsible person maintained by our partner.

Please refer to our country-specific website for more information.

Step 1

Download the appropriate form available below and fill out a Report of Adverse Drug Reactions. Before filling out the Report of Adverse Drug Reactions, please acquaint yourself with DRUG ADVERSE REACTION – PHARMACOVIGILANCE PRIVACY CLAUSE, which is available here.

Step 2

Send the filled form to our contact in the channel that is most convenient to you.

Step 3

The provided information will be used to perform functions of pharmacovigilance specified in the regulatory enactments of Olpha in order to collect information on observed adverse reactions. This information will help to decrease and prevent possible risks regarding to the use of medicinal products. The information will be used only in accordance with the intended purpose and to the extent necessary to achieve it.

Please note that the employees of our local partner or Olpha have the rights to contact you to clarify the given information in a report, if necessary.

Reporting form
for healthcare professionals

Download

Reporting form for patients / their representatives / others

Download

Dr. Uldis Armanis

Mg.sc.sal.EU
Qualified Person Responsible for Pharmacovigilance at Olpha

Our Contacts

Phone: +371 67013724
Mobile phone: +371 26137761
E-mail: [email protected]
Fax: (+371) 67013778
Skype: adr_of
Whatsapp; Viber: +371 26137761

Contacts on data protection

Email: [email protected]
Mobile phone: +371 2832 7856

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Attention!

Information on prescription medications should only be viewed by healthcare professionals.

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