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 products, 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:

+40749144434 (mobile phone)
+40213504640 (landline)
pharmacovigilance@rompharm.ro (email)

– Fill in and submit online the adverse reactions reporting form:

What does the Adverse reactions reporting form contain?

Side effects, overdose, abuse, misuse, and lack of therapeutic effect.
Information on the use of the drug during pregnancy and /or lactation.
Complaints about the quality of medicinal products.

Vigilance - Safety of use of Rompharm's medical devices

Rompharm Company continuously monitors the safety and performance of CE0050 certified medical devices in its portfolio.

If you suspect an adverse reaction or quality defect of a Rompharm medical device:

– contact the Rompharm medical representative or report directly to the Rompharm Pharmacovigilance Department:

+40749144434 (mobile phone)
+40213504640 (landline)
pharmacovigilance@rompharm.ro (email)

– Fill in and submit online the Medical device adverse reaction/quality defect reporting form:

Medical information for healthcare professionals

According to Law 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 professional (doctor, pharmacist, or nurse):

If you wish to report a quality defect that you noticed before the administration of the medical device, please provide a full description of the incident in the Event Description section.
PRIMARY REPORTER INFORMATION

NAME
EMAIL
PHONE NUMBER
COUNTRY/ADDRESS (where the event occurred)
DATE OF REPORT (Date of first awareness - dd.mm.yyyy)
MEDICAL DEVICE INFORMATION
Medical device Brand Name
Medical device description
Operator of device at the time of the adverse event/reaction
Usage of device
Expiry Date (dd.mm.yyyy)
Batch No or Serial no
Route(s) of administration
Dose / Number of medical devices administered
Indication for which medical device was administered
Medical Device Current Location (i.e. healthcare facility, distributor, patient/user, discarded, in transit to manufacturer, remains implanted, manufacturer, unknown)
Distributor (Name, address, phone number, email, fax, contact person)
Manufacturer (Name, address, phone number, email, fax, contact person)
ASSOCIATED MEDICAL DEVICES (if applicable)
Needle - Batch no
Expiry Date (dd.mm.yyyy)
MEDICAL DEVICE EVENT / REACTION / QUALITY DEFECT DESCRIPTION
Location of adverse reactions
Was the event/issue noted
Adverse event/reaction description
Onset date (dd.mm.yyyy)
Stop Date or Duration
Severity / intensity
Outcome * *Outcome Coefficient 1 = No serious outcome; 2 = Indirect harm; 3 = Required intervention to prevent permanent damage; 4 = Disability or Permanent damage; 5 = Hospitalization–initial or prolonged; 6 = Life-threatening; 7 = Death
Please provide a comprehensive description of the incident, including (1) what went wrong with the device (if applicable) and (2) a description of the health effects (if applicable), i.e. clinical signs, symptoms, conditions as well as the overall health impact (outcome)
Current health status of the patient
Death
Date (dd.mm.yyyy)
PATIENT INFORMATION (if appropriate)
Date of Birth (dd/mmm/yyyy)
Age at time of event (years)
Gender
Height (cm)
Weight (kg)
Ethnic origin
PATIENT MEDICAL HISTORY (if applicable, including pre-existing condition, previous known reactions, allergies, cutaneous and other pathologies)

Corrective treatments/remedial actions:
CONCOMITANT DRUGS (if applicable)

Drug
Dose
Frequency
Route of Admin.
Start Date
Stop Date
Indication

Adverse reaction reporting form PV Paec_1216_F1_ed.2 Confidential

EVENTS REPORTING FORM TO A MEDICAL DEVICEM-Pdm-59_F2_ed3

Adverse reaction reporting form
PV Paec_1216_F1_ed.2

Confidential

EVENTS REPORTING FORM TO A MEDICAL DEVICE
M-Pdm-59_F2_ed3