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PHARMACOVIGILANCE – SAFETY USE OF ROMPHARM s MEDICINAL PRODUCTS Rompharm carries out continuous monitoring activities of the safety of the medicinal products for which Rompharm holds a Marketing Authorization (MA), throughout their life cycle, thus contributing to the protection and promotion of public health.
Report an adverse reaction An adverse reaction is defined as a harmful and unintentional response caused by a medicinal product. If you (as a patient) or one of your patients (as a doctor or pharmacist) suspects side effects to one of our medicinal product even if they are not mentioned in the Package Leaflet or Summary of Product Characteristics, please contact us or complete the adverse reactions report: - Directly to Rompharm Pharmacovigilance Department at the phone numbers:
- Adverse reactions reporting form Please send it by fax or e-mail to: or Fax:
What the Adverse reactions reporting form contains? - Side effects, overdose, abuse, misuse, lack of therapeutic effect. - Information on the use of the drug during pregnancy and /or lactation. - Complaints about the quality of medicinal products.
Medical information for healthcare professionals According to the Low no. 95/2006 on the healthcare reform, Title XVII, access to information on these medicinal products is allowed exclusively to the professional community. By accessing this section, you declare under your own responsibility that you are a healthcare professionals (doctor or pharmacist or nurse):
VIGILANCE - SAFETY OF USE OF ROMPHARM MEDICAL DEVICES Rompharm Company conducts continuous monitoring of the safety and performance of CE0050 certified medical devices in its portfolio. • Medical device adverse reaction/quality defect reporting form If you suspect an adverse reaction or quality defect to a Rompharm medical device, contact the Rompharm medical representative or report directly to the Rompharm Pharmacovigilance Department at the telephone or fax numbers or the e-mail address shown below by filling the reporting form.
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