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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
C10AA01 SIMVAKEY G Simvastatin - 20mg 20mg Tablet, film coated 716,268 L.L
D06BA51 HYALO4 PLUS G Hyaluronic acid (sodium) - 0.2%, Silver sulfadiazine - 1% Cream 466,313 L.L
G03GB02 CLOMIFERT G Clomifene citrate - 50mg 50mg Tablet 395,090 L.L
J01CA04 AMOXYDIL G Amoxicillin (trihydrate) - 500mg/5ml 500mg/5ml Powder for suspension 218,854 L.L
J01FA10 ZOMAX G Azithromycin (dihydrate) - 200mg/5ml 200mg/5ml Powder for suspension 258,018 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 20mg 20mg Tablet, film coated 103,165,573 L.L
L02BG03 ZORTEX G Anastrozole - 1mg 1mg Tablet, film coated 1,944,092 L.L
M01AC01 INFLACAM G Piroxicam - 20mg/ml 20mg/ml Injectable solution 190,826 L.L
R01AB01 VAPICIL MICRODOSER G Phenylephrine - 2.5mg/ml, Dimethindene maleate - 0.25mg/ml Spray 239,204 L.L
R06AE09 CALIVIDA G Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 447,948 L.L
A04AA01 ONDANSETRON ARROW G Ondansetron - 8mg 8mg Tablet, orodispersible 1,280,682 L.L
A10BD07 SAGIMET G Metformin HCl - 850mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,463,892 L.L
B01AC06 ASPI-COR G Acetylsalicylic acid - 81mg 81mg Tablet, enteric coated 690,735 L.L
B05BB02 2.5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 2.5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 150,543 L.L
C09AA03 TENSIKEY G Lisinopril - 5mg 5mg Tablet 456,906 L.L
C10AA01 SIMVASTATIN NORMON G Simvastatin - 20mg 20mg Tablet, film coated 264,737 L.L
J01CA04 AMOXICILLINE ARROW LAB G Amoxicillin (trihydrate) - 1g 1g Tablet, dispersible 940,690 L.L
L01EA02 ELPIDA G Dasatinib - 20mg 20mg Tablet, film coated 103,165,573 L.L
N01BB58 ARTICAINE MEDIS ADRENALINE G Articaine HCl - 40mg/ml, Adrenaline - 0.07mg/ml Injectable solution 1,881,380 L.L
N03AX16 GABRIKA 150 G Pregabalin - 150mg 150mg Capsule 819,104 L.L
R06AE09 LEVOTREX G Levocetirizine dihydrochloride - 5mg 5mg Tablet, film coated 447,948 L.L
A04AA01 ONZETRAN OD G Ondansetron - 8mg 8mg Tablet, orodispersible 1,023,880 L.L
A10BD07 SITAMET G Metformin - 850mg, Sitagliptin - 50mg Tablet, film coated 2,301,079 L.L
B01AC06 ASPICOT G Acetylsalicylic acid - 81mg 81mg Tablet, enteric coated 353,239 L.L
B05BB02 DEXTROSE 2.5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 2.5g/100ml Injectable solution 176,974 L.L
C01DA02 NITROGLICERINA BIOINDUSTRIA L.I.M. G Nitroglycerine - 50mg/50ml 50mg/50ml Injectable concentrate for solution 1,057,604 L.L
C10AA01 SIMVASTATIN-REMEDICA G Simvastatin - 20mg 20mg Tablet, film coated 542,912 L.L
D06BA51 SILVEZ PLUS G Silver sulfadiazine - , Chlorhexidine - Cream 349,399 L.L
G03XC01 EVA TABLET G Raloxifene HCl - 60mg 60mg Tablet 1,354,081 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 1g 1,000mg Tablet, film coated 657,246 L.L
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