Pharmacovigilance & Patient Safety

EndoCare+ receives safety information related to its distributed products. Our pharmacovigilance activities are supported by documented procedures and aligned with internationally recognized pharmacovigilance principles and applicable regulatory requirements. We receive reports regarding:

Suspected Adverse Drug Reactions

Adverse Events

Medication Errors

Product-related Safety Concerns

Lack of Efficacy (where clinically relevant)

Other safety information

What Should Be Reported?

Suspected Adverse Reactions

Medication Errors

Product Quality-Related Safety Concerns

Lack of Efficacy

Overdose or Misuse

Pregnancy or Breastfeeding Exposure

Other Safety Information

Who Can Report?

Healthcare Professionals

Pharmacists

Patients & Caregivers

Business / Distribution Partners

Other Reporters

Urgent Safety Information

For serious or urgent safety information, please contact our Pharmacovigilance team directly.

Khairallah Yahya

Pharmacovigilance Manager

Telephone Email

Medical Emergency Disclaimer

For medical emergencies, seek immediate medical attention from an appropriate healthcare facility. This reporting form is not a substitute for emergency medical care.

Product Quality Complaint

For suspected defects, damaged packaging, labeling issues, contamination, leakage, missing contents, or other product quality concerns.

Report a Product Quality Complaint

1. Patient Information

Do not provide the patient's full name or unnecessary personal identifying information.

Patient Initials / Code (Optional)

Age or Age Group

Gender

Pregnancy / Breastfeeding

Relevant Medical History (Optional)

2. Medicine Details

Product Name *

Active Ingredient

Strength

Dosage Form

Batch/Lot Number

Expiry Date

Indication / Reason for Use

Dose / Dosing Frequency

Route of Administration

Treatment Start Date

Treatment Stop Date

Action Taken with Product

3. Adverse Event / Safety Information

Date of Onset *

Was the event serious?

Severity (Intensity)

Outcome of Event

Detailed Description of the Event

4. Medical Information

Concomitant Medicines / Relevant Information

Relevant Medical History / Other Conditions (Optional)

Supporting documents (medical reports, photos) can be requested during follow-up.

5. Reporter Information

Information submitted through this form is used for pharmacovigilance and patient-safety purposes, including case assessment, follow-up and applicable regulatory obligations.

Full Name *

Reporter Category *

Phone / Email *

Country / Location

6. Privacy & Submit

Please do not submit unnecessary personal or identifying information. Information provided will be handled in accordance with applicable data protection requirements and EndoCare+ pharmacovigilance procedures.

Website

How We Handle Safety Reports

Receive

Safety information is received through designated reporting channels.

Record

Reports are documented for pharmacovigilance assessment.

Assess

Available information is reviewed for completeness, seriousness and safety relevance.

Follow Up

Additional information may be requested when necessary.

Escalate & Report

Cases are managed and escalated in accordance with applicable regulatory requirements and relevant contractual obligations.