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Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization

 
Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization
 

This section provides a comprehensive overview of the procedures and tools available to Healthcare Professionals, Market Authorization Holders and the General Public to report adverse events associated with medicinal products and vaccines in Lebanon.
 
How to report

You can send the case reports using the following tools:
 
  1. For Healthcare Professionals and the Public
The Lebanese National Pharmacovigilance Program has adapted two user-friendly tools: one for Adverse Drug Reactions (Vigimobile e-Reporting e-Form) and another for reporting Adverse Events Following Immunization (Vigimobile e-Form). Both tools may be accessed by healthcare professionals and the general public.
 
  1. The VigiMobile e-Form and e-Reporting e-Form:
The VigiMobile e-Form and e-Reporting e-Form are the latest tools launched in January 2025 by the Lebanese National Pharmacovigilance Program. These digital platforms were introduced to enhance the reporting process, with the e-Reporting e-Form designed for Adverse Drug Reactions (ADRs) and the VigiMobile e-Form specifically for Adverse Events Following Immunization (AEFIs).

How to Download on Android Phones
 
  1. Scan the QR Code by pressing the link
  2. Click the three dots in the top-right corner
  3. Choose Install app
  4. VigiMobile e-Form/e-Reporting e-Form now appears as an app
 
How to Download on Apple IOS Phones
 
  1. Scan the QR Code by pressing the link
  2. Click on the share button
  3. Add VigiMobile to the home screen
  4. VigiMobile e-Form/e-Reporting e-Form now appears as an app

How to Download on Windows
  1. Press on the link
  2. Install from the Browser menu
  3. VigiMobile e-Form/e-Reporting e-Form is now installed 
 
Scan QR Codes to Report:
  1. ADRs Following Medication Use
  1. AEFIs Following Vaccine Use
Or use the following link: LNPVP: e-Reporting eForm Or use the following link: LNPVP: VigiMobile eForm
 
  1. Direct Contact with the Lebanese National Pharmacovigilance Program:
You may contact the Lebanese National Pharmacovigilance Program through:
  • Email Address:
  • Phone number of the Quality Assurance of Pharmaceutical Products Program: 01-830254   
 
  1.  For Market Authorization Holders:
Based on the Ministerial Resolution MR #181 issued in 2021, MAHs should adhere to the internationally agreed ICH guidelines and standards and send the reports in XML format as specified in ICH E2B (R2 or R3) guidelines

(https://www.moph.gov.lb/userfiles/files/Quality%26Safety/PharmacovigilanceSystemInLebanon/Karar%20181-2021.pdf).

All XML files should be sent to the following emails: pv@moph.gov.lb, and pv.moph@gmail.com.
 
As for what to report or report type, you can refer to Module VI:
https://moph.gov.lb/en/Pages/4/44742/pharmacovigilance-system-lebanon#/en/view/70479/lebanese-guideline-on-good-pharmacovigilance-practices-lgvp-
 
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ATC Name B/G Ingredients Dosage Form Price
B05BC01 MANNITOL G Mannitol - 10g/100ml 10g/100ml Injectable solution 329,815 L.L
C09BA05 TRILTEC PLUS G Ramipril - 5mg, Hydrochlorothiazide - 12.5mg Tablet 2,189,823 L.L
C10AA05 STORVAS G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 362,837 L.L
G04BE03 VIGORAM G Sildenafil citrate - 50mg 50mg Tablet 330,585 L.L
J01CR02 AMOCLAN FORTE G Amoxicillin (trihydrate) - 500mg, Clavulanic Acid (potassium) - 125mg 625mg Tablet 170,668 L.L
J01MA01 OFLACIN G Ofloxacin - 200mg 200mg Tablet, film-scored 602,041 L.L
M01AE01 IBUPROFEN B. BRAUN G Ibuprofen - 600mg/100ml 600mg/100ml Injectable solution 550,975 L.L
N02AJ13 MOLCET G Paracetamol - 325mg, Tramadol - 37.5mg Tablet 317,403 L.L
N06AB06 SOLOTIK G Sertraline HCl - 100mg 100mg Tablet, film coated 616,824 L.L
R02A TRACHISAN G Lidocaine HCl - 1mg, Tyrothricin - 0.5mg, Chlorhexidine gluconate - 1mg Lozenge 228,453 L.L
R06AX26 EXOFEN G Fexofenadine HCl - 180mg 180mg Tablet, film coated 287,582 L.L
B01AE07 DAXATRAN G Dabigatran etexilate (mesilate) - 150mg 150mg Capsule, hard 2,576,338 L.L
B05BC01 MANNITOL G Mannitol - 10g/100ml 10g/100ml Injectable solution 494,147 L.L
C10AA05 TARDELIP G Atorvastatin - 10mg 10mg Tablet, film coated 688,559 L.L
D07AC13 KONEX G Mometasone furoate - 0.1% 0.1% Solution 385,683 L.L
G04BE03 VONTA G Sildenafil citrate - 50mg 50mg Tablet, film coated 335,961 L.L
J01CR02 CURAM G Amoxicillin (trihydrate) - 500mg, Clavulanic Acid (potassium) - 125mg 625mg Tablet, film coated 386,869 L.L
J01MA01 OFLOMED G Ofloxacin - 200mg 200mg Tablet, film-scored 601,530 L.L
J07AH MENFIVE G Meningococcal (serogroups A, C, Y, W, X) Polysaccharide conjugate vaccine - Injectable freeze dried powder + diluent 3,527,587 L.L
L01EF01 PALBRANCE 75 G Palbociclib - 75mg 75mg Capsule 168,011,222 L.L
N02AJ13 TRAMADOL/PARACETAMOL ARROW LAB G Tramadol - 37.5mg, Paracetamol - 325mg Tablet, coated 205,608 L.L
N06AB06 SERTRALINE BIOGARAN G Sertraline HCl - 25mg 25mg Capsule 130,353 L.L
R02A CHLORASEPTIC TOTAL SORE THROAT + COUGH LOZENGES WILD CHERRY G Benzocaine - 6mg, Dextromethorphan - 5mg, Menthol - 10mg Lozenge 537,537 L.L
R06AX26 FENADEX 180 G Fexofenadine HCl - 180mg 180mg Tablet, coated 295,645 L.L
A06AB02 SUPPOLAX G Bisacodyl - 10mg 10mg Suppository 575,270 L.L
B05BC01 MANNITOL 10% USP INJECTION G Mannitol - 10% 10% Injectable solution 430,943 L.L
C10AA05 TARDEN G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 688,559 L.L
D07AC13 METASONE G Mometasone furoate - 0.1% 0.1% Lotion 239,332 L.L
G04BE03 VONTA G Sildenafil citrate - 50mg 50mg Tablet, film coated 90,037 L.L
J01CR02 JULMENTIN FORTE G Amoxicillin (trihydrate) - 500mg, Clavulanic Acid (potassium) - 125mg 625mg Tablet, film coated 245,923 L.L
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