GEROPHARM Ltd pays particular attention to safety monitoring of its products. Currently the company maintains a pharmacovigilance system that is organized in accordance with international standards and requirements of the Russian Competent Authorities.
Adverse reaction is a negative reaction of the organism caused by taking a medicine.
Information on adverse reactions is reported to the GEROPHARM’s Pharmacovigilance service by healthcare professionals or patients.
We regularly monitor publications on our medicinal products. All safety information is stored in a database, analyzed and used to manage benefit-risk plan.
We communicate with Competent Authorities of the countries where our products are marketed. Regular trainings are held to improve the quality of pharmacovigilance.
The main purpose of pharmacovigilance activity is to guarantee the quality and safety of our medical products, provide healthcare professionals and patients with complete and impartial information and minimize potential risks associated with the products of GEROPHARM Ltd.
1. When to report?
Please report to our pharmacovigilance service the following cases:
- Side effect that could be associated with taking a medicinal product
- Lack of efficacy of a medicinal product
- Drug interactions that are not described in the product information sheet
- Counterfeit medicines
- Medication errors
Misuse of a drug
- Adverse reactions while using a medical device marketed by GEROPHARM Ltd
It is important to report even if:
- You are not absolutely sure that the adverse event is associated with the product
- You do not have all the information required in the form
2. How to report?
Report to GEROPHARM Ltd pharmacovigilance service by e- mail, mail or fax as soon as possible in any of the above mentioned cases.
3. Where to report?
- E-mail: firstname.lastname@example.org
- Hotline: 8- 800-333-43-76 (Free in Russia)
- GEROPHARM Ltd agencies worldwide:
o The Republic of Azerbaijan: Tel. 8(10-994-12)599-08-80
o The Republic of Georgia: Tel. 8(10-995-32)243-43-19
o The Republic of Kazakhstan: Tel. 8(10-7-727)334-15-70
o The Republic of Belarus: Tel. 8(10-375-17)266-22-59
- Fax: 8(812)493-55-69
- Mail: 34 A Svyazi Street, Strelna, Saint Petersburg, 198515
- You can also report to a medical representative of GEROPHARM Ltd. Your message will be forwarded to the Pharmacovigilance department
4. Personal data privacy
Reporting to GEROPHARM’s Pharmacovigilance department is equivalent to the patient's consent to processing and storage of his/her personal data by GEROPHARM Ltd or an authorized person.
Please note that:
- A person reporting a case accepts that provided information is complete, accurate and reliable
- The provision of information may not violate any applicable law, the legitimate rights and interests of third parties
- A person reporting a case provides personal information about himself only
All personal information is treated as strictly confidential. This information will not be publicly disclosed. Nevertheless, it may be submitted to the Federal Service for Supervision of Healthcare unless otherwise stated.
GEROPHARM’s Pharmacovigilance service representative may contact a person who reported a case in order to clarify provided data.
The GEROPHARM Ltd company undertakes to stop processing personal data from the moment of receiving a request to do so by e-mail (email@example.com) or by our feedback form on the company's website (http://geropharm.ru/feedback/).
If you have any questions, please feel free to contact GEROPHARM Ltd hotline 8-800-333-43-76 (Free in Russia).