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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
A06AD11 DULACTA G Lactulose - 3.335g/5ml 3.335g/5ml Solution 566,974 L.L
B01AF01 ZARLAN G Rivaroxaban - 15mg 15mg Tablet, film coated 1,343,843 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 220,643 L.L
C02KX01 BOSENTAN ARROW G Bosentan (monohydrate) - 125mg 125mg Tablet, film coated 49,522,064 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 2.5mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
C10AA05 ATORLIP 20 G Atorvastatin (calcium) - 20mg 20mg Tablet, film coated 1,279,850 L.L
D07AD01 DERMASONE G Clobetasol (propionate) - 0.05% 0.05% Cream 119,026 L.L
J01CR02 MEGAMOX-JPI G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1g Tablet 338,648 L.L
J01MA02 CIPROMID G Ciprofloxacine (HCl) - 500mg 500mg Tablet, film coated 331,929 L.L
L01EF01 PALBOMED G Palbociclib - 125mg 125mg Capsule 25,799,521 L.L
L03AX03 SII-ONCO-BCG G Bacillus Calmette- Guerin Strain - 40mg/ml (1-8x10?CFU) 40mg/ml Injectable dry powder 6,987,981 L.L
N06AB10 PRAMACYT 10 G Escitalopram (oxalate) - 10mg 10mg Tablet, film coated 767,910 L.L
R03AC02 BUTALIN G Salbutamol (sulfate) - 2mg/5ml 2mg/5ml Syrup, sugar free 122,290 L.L
R06AX27 ESLORAT G Desloratadine - 5mg 5mg Tablet, film coated 331,929 L.L
A10BD20 EMPAZIMET G Metformin HCl - 1000mg, Empagliflozin - 5mg Tablet, film coated 1,840,168 L.L
B05CX01 10% DEXTROSE INJECTION USP G Dextrose,H2O - 10g/100ml 10% Injectable solution 252,820 L.L
C02KX01 PMS-BOSENTAN G Bosentan (monohydrate) - 125mg 125mg Tablet 77,539,821 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 5mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
C10AA05 ATORVA TAD G Atorvastatin - 20mg 20mg Tablet, film coated 1,087,169 L.L
G04BE08 APO-TADALAFIL G Tadalafil - 20mg 20mg Tablet 1,111,358 L.L
J01CR02 MOXICLAV G Amoxicillin (trihydrate) - 875mg, Clavulanic Acid (potassium) - 125mg 1g Tablet 349,399 L.L
J01MA02 CIPROPHARM G Ciprofloxacine (HCl) - 500mg 500mg Tablet, film-scored 354,774 L.L
L01EF01 PALBRANCE 125 G Palbociclib - 125mg 125mg Capsule 69,032,469 L.L
L03AX13 GLITAXON G Glatiramer acetate - 20mg/ml 20mg/ml Injectable solution 10,146,988 L.L
M01AE03 KETOPROFENE MACOPHARMA G Ketoprofen - 100mg/100ml 100mg/100ml Injectable solution 329,241 L.L
N06AB10 PRYLEX 10 G Escitalopram (oxalate) - 10mg 10mg Tablet, film coated 767,910 L.L
R03AC02 ASTHALIN G Salbutamol (sulfate) - 2.5mg/2.5ml 2.5mg/2.5ml Inhalation solution 325,210 L.L
R06AX27 ORADUS G Desloratadine - 5mg 5mg Tablet, film coated 383,955 L.L
A01AB09 MICONAZ G Miconazole nitrate - 20mg/g 20mg/g Gel 229,093 L.L
A06AD61 SOFLAX G Lactose - less than 6g/100ml, Galactose - less than 11g/100ml, Lactulose - 67g/100ml Solution 258,018 L.L
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