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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
G03XC01 RALOXIFENE ARROW G Raloxifene HCl - 60mg 60mg Tablet, coated 1,425,817 L.L
J01CA04 AMOXYDIL G Amoxicillin (trihydrate) - 500mg/5ml 500mg/5ml Powder for suspension 218,854 L.L
J01FA09 KLERIMED G Clarithromycin - 500mg 500mg Tablet 686,704 L.L
L01DB03 EPIRUBICINE VIATRIS 2MG/ML G Epirubicin HCl - 10mg/5ml 10mg/5ml Injectable solution 855,212 L.L
L04AX04 LENOMA G Lenalidomide - 15mg 15mg Capsule, hard 15,241,884 L.L
M04AA03 STABURIC G Febuxostat - 40mg 40mg Tablet, film coated 1,081,345 L.L
N02BF02 NEUREXAL G Pregabalin - 75mg 75mg Capsule 637,365 L.L
N07AX01 JAMP PILOCARPINE G Pilocarpine HCl - 5mg 5mg Tablet 3,668,690 L.L
R05C PULMONAL SIROP G Belladona tincture - 0.5g/5ml, Drosera tincture - 2g/5ml, Ammonium bromide - 2g/5ml, Sodium benzoate - 2g/5ml Syrup 148,463 L.L
S01FA06 TROPICIL TOP G Tropicamide - 10mg/ml 10mg/ml Drops solution 200,233 L.L
A06AD61 SOFLAX G Lactose - less than 6g/100ml, Galactose - less than 11g/100ml, Lactulose - 67g/100ml Solution 258,018 L.L
B01AF01 ZARLAN G Rivaroxaban - 15mg 15mg Tablet, film coated 2,015,764 L.L
B05BC01 MANNITOL 10% USP INJECTION G Mannitol - 10% 10% Injectable solution 430,943 L.L
C10AA05 LORVAST G Atorvastatin (calcium) - 10mg 10mg Tablet, film coated 1,114,045 L.L
J01CA04 AMOXICILLINE ARROW LAB G Amoxicillin (trihydrate) - 1g 1g Tablet, dispersible 940,690 L.L
J01FA09 RITHROCID G Clarithromycin - 500mg 500mg Tablet, film coated 686,704 L.L
L01DB03 EPIRUBICINE VIATRIS 2MG/ML G Epirubicin HCl - 50mg/25ml 50mg/25ml Injectable solution 3,914,242 L.L
L04AX04 SOTIRA G Lenalidomide - 15mg 15mg Capsule 76,208,289 L.L
N02BF02 PLENICA G Pregabalin - 75mg 75mg Capsule 697,454 L.L
N05AX08 DEPIA G Risperidone - 2mg 2mg Tablet, scored 307,164 L.L
N07BB03 ACAMPROSATE BIOGARAN G Acamprosate - 333mg 333mg Tablet, gastroresistant 3,641,813 L.L
R05C SULDEX G Caffein anyhdrous - 0.216g, Antipyrine - 0.972g, Potassium sulfaguaiacolate - 1.44g Syrup 152,302 L.L
S01FB01 PHENYLEPHRINE/ COOPER G Phenylephrine HCl - 10% 10% Drops solution 278,175 L.L
L01AA09 BENDAVIVAL G Bendamustine HCl - 100mg 100mg Injectable concentrated powder for solution L.L
A10BF01 GLUFIX G Acarbose - 50mg 50mg Tablet 1,294,120 L.L
B01AF01 ZARLAN G Rivaroxaban - 15mg 15mg Tablet, film coated 1,343,843 L.L
B05BC01 MANNITOL 10% USP INJECTION G Mannitol - 10% 10% Injectable solution 326,367 L.L
C09BA05 TRILTEC PLUS G Ramipril - 10mg, Hydrochlorothiazide - 12.5mg Tablet 2,243,577 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 10mg 10mg Tablet 966,287 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 1g 1,000mg Tablet, film coated 683,273 L.L
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