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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
M05BB03 ACIDE ALENDRONIQUE/ VITAMINE D3 BGR G Alendronic acid - 70mg, Colecalciferol - 5600UI Tablet 815,712 L.L
N05AX15 REAGILA G Cariprazine HCl - 1.5mg 1.5mg Capsule, hard 6,394,003 L.L
P01AB01 METRO-SOLUTIONS G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 166,381 L.L
V03AB35 PLIBADEX G Sugammadex - 200mg/2ml 500mg/5ml Injectable solution 46,089,190 L.L
A04AA01 ODNATRON G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 952,784 L.L
A10BD07 SAGIMET G Metformin HCl - 1000mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,551,690 L.L
B01AC04 CLOTRIX 75 G Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,035,399 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 182,720 L.L
C01CA03 NORADRENALINE NOREPINEPHRINE (tartrate) Aguettant G Norepinephrine tartrate - 2mg/ml 2mg/ml Injectable solution 1,896,162 L.L
J01AA02 TOLEXINE G Doxycycline (monohydrate) - 100mg 100mg Tablet, microgranules 589,947 L.L
J01DH03 ERTAPENEM INJECTION G Ertapenem - 1g 1g Injectable concentrate for solution 26,153,163 L.L
J05AF10 APO-ENTECAVIR G Entecavir - 0.5mg 0.5mg Tablet 28,943,287 L.L
N03AX11 TOPIRAMATE ARROW G Topiramate - 100mg 100mg Tablet, film coated 1,440,599 L.L
N05AX15 REAGILA G Cariprazine HCl - 3mg 3mg Capsule, hard 6,394,003 L.L
P01AB01 POLGYL G Metronidazole - 0.5% 0.5% Injectable solution 134,384 L.L
A04AA01 ONDANSETRON HIKMA G Ondansetron (HCl dihydrate) - 8mg/4ml 8mg/4ml Injectable solution 4,018,089 L.L
A10BD07 SITAMET G Metformin - 1000mg, Sitagliptin - 50mg Tablet, film coated 2,444,896 L.L
B01AC04 GREPID G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 1,248,335 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 217,210 L.L
C01CA03 NORADRENALINE RENAUDIN G Norepinephrine tartrate - 8mg/4ml 0.2% Injectable solution 2,000,981 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,067,011 L.L
D06AX DERMOTRACIN G Neomycin sulfate - 165.000IU/150ml, Bacitracin - 15.500IU/150ml Powder 737,770 L.L
J01DH51 CELLABAXIN G Imipenem (monohydrate) - 500mg, Cilastatin (sodium) - 500mg Injectable solution 10,699,559 L.L
J05AF10 AVIRAVIR G Entecavir monohydrate - 0.5mg 0.5mg Tablet, film coated 32,224,230 L.L
N03AX11 TOPIRATE 100 BENTA G Topiramate - 100mg 100mg Tablet, film coated 2,559,700 L.L
N05AX15 REAGILA G Cariprazine HCl - 4.5mg 4.5mg Capsule, hard 6,394,003 L.L
P01AB01 SOLUFLEX METRONIDAZOLE G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 162,541 L.L
R05FB BRONCHOPHANE G Dextrometorphan HBr - 4.58mg/5ml, Diphenydramine HCl - 5mg/5ml, Ephedrine HCl - 7.5mg/5ml, Guaifenesin - 50mg/5ml Syrup 115,570 L.L
V03AC03 DIFIRAX G Deferasirox - 250mg 250mg Tablet, dispersible 23,213,276 L.L
A04AA01 ONDANSETRON MEDIS G Ondansetron - 8mg/4ml 8mg/4ml Injectable solution 1,919,007 L.L
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