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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
N06AA01 DESIPRAMINE G Desipramine (HCl) - 50mg 50mg Tablet, scored 656,563 L.L
R06AE07 CETALLERG G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, film coated 180,075 L.L
V07AB01 STERILE WATER FOR INJECTION USP G Water for injection - Water for injection, irrigation 264,311 L.L
B05BC01 MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 402,213 L.L
C09AA05 RAMIPRIL-REMEDICA G Ramipril - 10mg 10mg Tablet 896,343 L.L
C10AA05 ATORVAKEY-10 G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 362,837 L.L
J01CR02 MOXICLAV G Amoxicillin - 1g, Clavulanic Acid - 200mg 1.2g Injectable powder for solution 162,605 L.L
J01FA10 AZOX 250 G Azithromycin (dihydrate) - 250mg 250mg Capsule 346,711 L.L
M01AB55 DIOXAFLEX B12 G Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg Injectable solution 1,104,639 L.L
N01BB09 ROPIVACAINE B. BRAUN G Ropivacaine HCl - 75mg/10ml 7.5mg/ml Injectable solution 4,831,114 L.L
N03AX14 ZITERA G Levetiracetam - 1,000mg 1,000mg Tablet, film coated 3,225,222 L.L
R01AA07 DECOZAL G Xylometazoline HCl - 0.1% 0.1% Metered dose spray 147,823 L.L
R06AE07 CETIMED G Cetirizine (dihydrochloride) - 10mg 10mg Tablet, scored 360,918 L.L
V07AB01 STERILE WATER FOR IRRIGATION G Water for Irrigation - Water for injection, irrigation 203,481 L.L
A06AB02 SUPPOLAX G Bisacodyl - 10mg 10mg Suppository 575,270 L.L
B01AE07 DAXATRAN G Dabigatran etexilate (mesilate) - 150mg 150mg Capsule, hard 2,576,338 L.L
B05BC01 MANNITOL 20% INJECTION, USP G Mannitol - 20g/100ml 20g/100ml Injectable solution 402,213 L.L
C01EB17 BRAVIGO G Ivabradine (HCl) - 7.5mg 7.5mg Tablet, film coated 1,237,679 L.L
C09AA05 TRILTEC G Ramipril - 10mg 10mg Capsule 575,933 L.L
C10AA05 ATORVASTATINE ARROW GENERIQUES G Atorvastatin - 10mg 10mg Tablet, coated 567,102 L.L
G04BD08 ASOLFENA G Solifenacin succinate - 5mg 5mg Tablet, film coated 971,598 L.L
J01CR02 VAAMOX IV G Amoxicillin - 1g, Clavulanic Acid - 200mg Injectable powder 225,766 L.L
J01FA10 ERADECIN G Azithromycin - 250mg 250mg Capsule 354,774 L.L
L02BG04 APO-LETROZOLE G Letrozole - 2.5mg 2.5mg Tablet 1,962,010 L.L
M01AB55 DIOXAFLEX B12 G Diclofenac sodium - 75mg, Betamethasone (sodium phosphate) - 2mg, Hydroxocobalamin sulphate - 10mg Injectable solution 620,855 L.L
N01BB52 DILOCAIN 2% G Lidocaine HCl - 20mg/1.7ml, Epinephrine (bitartrate) - 0.0125mg/1.7ml Injectable solution 2,768,316 L.L
N03AX14 LEPITAM G Levetiracetam - 100mg/ml 100mg/ml Solution 1,336,163 L.L
R01AA07 DECOZAL G Xylometazoline HCl - 0.1% 0.1% Drops 145,135 L.L
R06AE07 CETRAK G Cetirizine (dihydrochloride) - 10mg 10mg Tablet 147,823 L.L
V07AB01 WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 2,706,319 L.L
    ...
    181
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