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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
M05BA06 BONAFOR G Ibandronic acid (monosodium monohydrate) - 150mg 150mg Tablet, film coated 383,955 L.L
N05AX08 RISCHOTIC OD 3 G Risperidone - 3mg 3mg Tablet, orally disintegrating 605,369 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 8mg, Naloxone HCl - 2mg Tablet, sublingual 7,382,584 L.L
R05CA12 HEDERAL G Dried Ivy leaf extract - 37mg/5ml 37mg/5ml Syrup 309,084 L.L
S01GX09 OLOPAT G Olopatadine (HCl) - 0.1% 0.1% Drops solution 524,099 L.L
A02BC01 EPIRAZOLE G Omeprazole - 20mg 20mg Capsule 208,296 L.L
A07AA02 MEDISTAN G Nystatin - 500,000IU/5ml 500,000IU/5ml Suspension 415,951 L.L
A10BH02 GLUNORM G Vildagliptin - 50mg 50mg Tablet 611,448 L.L
B01AF01 ZARLAN G Rivaroxaban - 10mg 10mg Tablet, film coated 1,439,255 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 10g/100ml 10g/100ml Injectable solution 219,493 L.L
C02KX01 PMS-BOSENTAN G Bosentan (monohydrate) - 125mg 125mg Tablet 77,539,821 L.L
C09BB06 ENEAS G Enalapril maleate - 10mg, Nitrendipine - 20mg Tablet 2,009,045 L.L
C10AA05 ATORLIP 20 G Atorvastatin (calcium) - 20mg 20mg Tablet, film coated 1,279,850 L.L
G04BD08 URICARE G Solifenacin succinate - 5mg 5mg Tablet, film coated 1,334,884 L.L
N05AX08 RISCHOTIC OD 4 G Risperidone - 4mg 4mg Tablet, orally disintegrating 605,369 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 16mg, Naloxone HCl - 4mg Tablet, sublingual 14,284,125 L.L
R05CA12 LIBLAB COUGH SYRUP G Dried Ivy leaf extract - 35mg/5ml 35mg/5ml Syrup 237,860 L.L
S01GX09 OLOPAT UD G Olopatadine (HCl) - 0.1% 0.1% Drops solution 1,523,917 L.L
L01XA02 KARBOTEEN G Carboplatin - 150mg/15ml 150mg/15ml Injectable solution L.L
A02BC01 GASTRAZOLE G Omeprazole - 20mg 20mg Capsule 185,450 L.L
A07AA02 MEDISTAN G Nystatin - 200.000IU 200.000IU Lozenge 418,511 L.L
A10BH02 VILDAVITAE G Vildagliptin - 50mg 50mg Tablet 665,202 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 10g/100ml 10g/100ml Injectable solution 170,630 L.L
C02KX01 TRACTAN G Bosentan (monohydrate) - 125mg 125mg Tablet, film coated 47,747,570 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 2.5mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
C10AA05 ATORVA TAD G Atorvastatin - 20mg 20mg Tablet, film coated 1,087,169 L.L
D07AC14 PRENIDERM G Methylprednisolone aceponate - 0.1% 0.1% Cream 312,283 L.L
G04BD08 URISOL G Solifenacin succinate - 5mg 5mg Tablet, film coated 1,334,884 L.L
J01CR02 AMOCLAN FORTE G Amoxicillin (trihydrate) - 250mg/5ml, Clavulanic Acid (potassium) - 62.5mg/5ml 312mg/5ml Powder for suspension 288,926 L.L
L01EA01 APO-IMATINIB G Imatinib - 100mg 100mg Tablet 18,838,684 L.L
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