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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
L04AX07 MAROVAREX G Dimethyl Fumarate - 120mg 120mg Capsule, hard, gastro-resistant 9,838,676 L.L
N02CC01 SUMAREX G Sumatriptan (succinate) - 100mg 100mg Tablet, film coated 1,088,512 L.L
N05AX12 ABIPREX 10 G Aripiprazole - 10mg 10mg Tablet 1,075,074 L.L
R05CA12 HEDECTON COUGH G Ivy leaf soft extract - 40mg/5ml Syrup 467,657 L.L
L01BC05 GEMCITABINE THYMOORGAN G Gemcitabine (HCl) - 200mg 200mg Injectable powder for solution L.L
A02BC01 GASTRAZOLE G Omeprazole - 20mg 20mg Capsule 377,620 L.L
A10BH02 VILDIAB G Vildagliptin - 50mg 50mg Tablet 806,306 L.L
B01AF02 APIXEL G Apixaban - 5mg 5mg Tablet, film coated 1,750,579 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 10g/100ml 10g/100ml Injectable solution 252,820 L.L
C02KX01 BOSENTAN ARROW G Bosentan (monohydrate) - 62.5mg 62.5mg Tablet, film coated 51,483,159 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 5mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
C10AA05 ATORVAKEY-20 G Atorvastatin (calcium) - 20mg 20mg Tablet 362,837 L.L
J01CR02 MOXICLAV FORTE G Amoxicillin (trihydrate) - 250mg/5ml, Clavulanic Acid (potassium) - 62.5mg/5ml 312.5mg/5ml Powder for suspension 298,333 L.L
J01FA10 APO-AZITHROMYCIN Z G Azithromycin - 250mg 250mg Tablet 481,096 L.L
L01EA01 CEMIVIL G Imatinib - 100mg 100mg Tablet, film coated 12,763,090 L.L
L04AX07 MAROVAREX G Dimethyl Fumarate - 240mg Capsule, hard, gastro-resistant 60,848,734 L.L
M05BA07 DRONEL 35 G Risedronate sodium - 35mg 35mg Tablet, film coated 511,940 L.L
N05AX12 ATYPRAL G Aripiprazole - 10mg 10mg Tablet 712,237 L.L
N07CA01 ALVIGO G Betahistine dihydrochloride - 16mg 16mg Tablet, scored 1,204,339 L.L
S01JA01 FLUORESCEIN SODIUM USP IV G Fluorescein sodium - 10% 10% Injectable solution 1,198,595 L.L
V03AF03 EUROFOLIC G Folic acid as Calcium Folinate Hydrate - 100mg/10ml 10mg/ml Injectable solution L.L
A02BC01 GASTRIMUT G Omeprazole - 20mg 20mg Capsule, hard, gastro-resistant 427,342 L.L
A10BH02 VLUDIN G Vildagliptin - 50mg 50mg Tablet 767,910 L.L
B01AF02 APO-APIXABAN G Apixaban - 5mg 5mg Tablet 3,084,119 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 10g/100ml 10g/100ml Injectable solution 284,997 L.L
C02KX01 PMS-BOSENTAN G Bosentan (monohydrate) - 62.5mg 62.5mg Tablet 77,539,821 L.L
C09BB07 RAMIPRIL/AMLODIPINE GENERICON G Ramipril - 10mg, Amlodipine - 5mg Capsule, hard 1,358,625 L.L
C10AA05 ATORVASTATIN PHARMADEX G Atorvastatin - 20mg 20mg Tablet 769,190 L.L
G04BD08 ASOLFENA G Solifenacin succinate - 10mg 10mg Tablet, film coated 971,598 L.L
J01CR02 AMOCLAN BID G Amoxicillin (trihydrate) - 200mg/5ml, Clavulanic Acid (potassium) - 28.5mg/5ml 228.5mg/5ml Powder for suspension 345,368 L.L
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