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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
L01EA02 DALEUBIN G Dasatinib - 50mg 50mg Tablet, film coated 97,680,409 L.L
L01EA02 DASATINIB NEAPOLIS G Dasatinib - 50mg 50mg Tablet, film coated 127,364,905 L.L
A04AD GRAVOL B Dimenhydrinate - 50mg 50mg Tablet 163,949 L.L
L01EA02 ELPIDA G Dasatinib - 50mg 50mg Tablet, film coated 127,364,905 L.L
B01AD02 ACTILYSE BioTech Alteplase - 50mg 50mg Injectable dry powder for solution+diluent 97,130,035 L.L
N06AA01 DESIPRAMINE G Desipramine (HCl) - 50mg 50mg Tablet, scored 656,563 L.L
N06AA12 DOXEPIN HCl G Doxepin (HCl) - 50mg 50mg Capsule 965,007 L.L
S01EE01 XALATAN B Latanoprost - 50mcg/ml 50mcg/ml Drops solution 704,173 L.L
S01EE01 MONOPROST G Latanoprost - 50mcg/ml 50mcg/ml Drops solution 1,187,957 L.L
N02AB03 DUROGESIC B Fentanyl - 8.4mg 50mcg/h Patch 3,019,614 L.L
D10AD06 AKLIEF B Trifarotene - 50mcg/g 50mcg/g Cream 4,359,425 L.L
R01AD08 RINISONA G Fluticasone propionate - 50mcg/actuation 50mcg/dose Spray, suspension 556,351 L.L
R01AD09 METASPRAY G Mometasone furoate (monohydrate) - 50mcg/dose 50mcg/dose Spray, suspension 349,399 L.L
R01AD09 MOMETASONE BIOGARAN G Mometasone furoate (monohydrate) - 50mcg/dose 50mcg/dose Spray, suspension 501,253 L.L
R01AD08 OTRIALLERGY B Fluticasone propionate - 50mcg/actuation 50mcg/actuation Spray, suspension 675,953 L.L
R01AD09 METASONE G Mometasone furoate - 50mcg/actuation 50mcg/actuation Spray 419,791 L.L
R03BA02 BUDENA G Budesonide - 50mcg/actuation 50mcg/actuation Inhalation suspension 823,775 L.L
R03BA05 FLIXOTIDE EVOHALER B Fluticasone propionate - 50mcg/actuation 50mcg/actuation Inhalation suspension 671,921 L.L
R03BB06 SEEBRI BREEZHALER B Glycopyronium Bromide - 50mcg 50mcg Capsule, inhalation 2,687,685 L.L
H03AA01 EUTHYROX B Levothyroxine sodium - 50mcg 50mcg Tablet, scored 391,058 L.L
B05CX01 DEXTROSE G Dextrose, H2O - 50g/100ml 50g/100ml Injectable solution 329,815 L.L
B05XA05 MAGNESIUM SULFATE G Magnesium sulfate, 7H2O - 50g/100ml 50g/100ml Injectable solution 897,510 L.L
M03AX01 DYSPORT BioTech Clostridium botulinum type A neurotoxin complex - 500units 500units Injectable powder for solution 42,726,155 L.L
J06BB04 IMMUNOGLOBULINE HUMAINE DE L'HEPATITE B LFB BioHuman Hepatitis B immunoglobulin (human) - 500UI/5ml 500UI/5ml Injectable solution 26,599,935 L.L
B02BD03 FEIBA BioHuman Factor VIII Inhibitor bypassing fraction - 500IU 500U (50U/ml) Injectable powder for solution+solvent 38,938,709 L.L
B02AA02 EXACYL B Tranexamic acid - 500mg/5ml 500mg/5ml Injectable solution 748,520 L.L
A11GA01 VITAMIN C S.A.L.F. G Ascorbic acid (vit C) - 500mg/5ml 500mg/5ml Injectable solution 498,566 L.L
V03AB35 PLIBADEX G Sugammadex - 500mg/5ml 500mg/5ml Injectable solution 94,888,925 L.L
V03AB35 PLIBADEX G Sugammadex - 200mg/2ml 500mg/5ml Injectable solution 46,089,190 L.L
J01CA04 AMOXYDIL G Amoxicillin (trihydrate) - 500mg/5ml 500mg/5ml Powder for suspension 218,854 L.L
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