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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
N03AG01 CONVULEX G Sodium valproate - 100mg/ml 100mg/ml Injectable solution 4,441,399 L.L
B05AA01 PLASBUMIN-20 ALBUMIN (HUMAN) BioHuman Albumin human - 20% 20% Injectable solution 3,641,813 L.L
B05XA03 0.45% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.45% 0.45% Injectable solution 137,902 L.L
B05AA01 UMAN ALBUMIN BioHuman Albumin human - 20g/100ml 10g/50ml Injectable solution 3,598,810 L.L
B05XA03 0.45% SODIUM CHLORIDE INJECTION USP G Sodium chloride - 0.45% 0.45% Injectable solution 155,139 L.L
A03BA01 ATROPINE G Atropine sulfate - 1mg/ml 1mg/ml Injectable solution 702,149 L.L
B05AA01 VIALEBEX BioHuman Albumin human - 200g/L 200g/L Injectable solution 3,417,391 L.L
B05XA03 HYPOTONIC SALINE G Sodium chloride - 0.45% 0.45% Injectable solution 149,393 L.L
G02CX01 TRACTOCILE B Atosiban acetate - 7.5mg/ml 7.5mg/ml Injectable solution 2,592,272 L.L
A03BA01 ATROPINE SULFATE RENAUDIN G Atropine sulfate - 1mg/ml 0.1% Injectable solution 397,777 L.L
B05AA01 YDRALBUM 200G/L BioHuman Albumin human - 10g/50ml Injectable solution 3,417,391 L.L
B05XA03 HYPOTONIC SALINE G Sodium chloride - 0.45% 0.45% Injectable solution 163,184 L.L
G02CX01 TRACTOCILE B Atosiban acetate - 7.5mg/ml 7.5mg/ml Injectable solution 8,282,804 L.L
A03BA01 ATROPINE I.V. 0.25 MG. G Atropine - 0.25mg/ml 0.25mg/ml Injectable solution 2,412,129 L.L
B05AA06 GELASPAN B Gelatine, succinylated - 4% 4% Injectable solution 9,107,572 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 133,856 L.L
A03BA01 ATROPINE G Atropine sulfate - 0.5mg/ml 0.5mg/ml Injectable solution 680,315 L.L
B05AA07 VOLUVEN B Starch poly(O-2-Hydroxyethyl) - 6% 6% Injectable solution 987,724 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 149,393 L.L
A03BA01 ATROPINE SULFATE RENAUDIN G Atropine sulfate - 0.5mg/ml 0.5mg Injectable solution 385,683 L.L
A12CX PHOSPHATE DIPOTASSIQUE RENAUDIN G Phosphate dipotassique - 174.20mg/ml 174.20mg/ml Injectable solution 1,189,301 L.L
B05BA01 AMINOVEN 10% B Glacial Acetic Acid 99% - 5.297g/l, L-Proline - 15.0g/l, L-Alanine - 15.0g/l, Glycine - 14.0g/l, L-Histidine - 3.00g/l, L-Arginine - 12.0g/l, L-Valine - 6.20g/l, L-Tryptophan - 2.00g/l, L-Threonine - 4.40g/l, L-Phenylalanine - 5.10g/l, L-Methionine - 4.30g/l, L-Lysine (monoacetate) - 6.60g/l, L-Leucine - 7.40g/l, L-Isoleucine - 5.00g/l Injectable solution 951,440 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 163,184 L.L
A03BA01 ATROPINE SULFATEAGUETTANT G Atropine - 0.1mg/ml 0.1mg/ml Injectable solution 7,805,376 L.L
B05BA01 AMINOVEN INFANT B L-Leucine - 13g/l, L-Isoleucine - 8g/l, L-Lysine Acetate - 12g/l, L-Methionine - 3.12g/l, L-Phenylalanine - 3.75g/l, L-Threonine - 4.40g/l, L-Tryptophan - 2.01g/l, L-Valine - 9g/l, Arginine - 7.5g/l, L-Histidine - 4.76g/l, Glycine - 4.15g/l, L-Taurine - 0.40g/l, L-Serine - 7.67g/l, L-Alanine - 9.3g/l, L-Proline - 9.71g/l, N-Acetyl-L-Tyrosine - 5.176g/l, N-Acetyl-L-Cysteine - 0.70g/l, L-Malic Acid - 2.62g/l 10% Injectable solution 880,217 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 176,974 L.L
M05BA06 BONVIVA B Ibandronic acid - 3mg/3ml 3mg/3ml Injectable solution 3,144,591 L.L
B05BA01 AMINOPLASMAL B. BRAUN B Amino acids - 10% 10% Injectable solution 1,036,103 L.L
B05XA03 SODIUM CHLORIDE G Sodium chloride - 0.45% 0.45% Injectable solution 161,805 L.L
B05XA03 SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45% 0.45% Injectable solution 161,314 L.L
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