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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
C09DX01 ARBITEN AM PLUS G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet 857,372 L.L
G03DA04 GESTA 400 G Progesterone - 400mg 400mg Pessary 1,083,137 L.L
J01AA02 DOXYLAG G Doxycycline (HCl) - 100mg 100mg Capsule 174,700 L.L
J01DH02 MEROZAN G Meropenem - 1g 1g Injectable powder for solution 6,443,725 L.L
J05AF10 AVIRAVIR G Entecavir monohydrate - 1mg 1mg Tablet, film coated 31,285,380 L.L
L01XX05 UNIDREA G Hydroxycarbamide (or Hydroxyurea) - 500mg 500mg Capsule, hard 2,539,862 L.L
M01AB05 EPARDEX G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 223,974 L.L
M05BA08 ZOLEDRONIC ACID HIKMA G Zoledronic acid (monohydrate) - 4mg/5ml 4mg/5ml Injectable concentrate for solution 9,098,466 L.L
P01AB01 METRONIDAZOLE B. BRAUN G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 102,132 L.L
R05DB13 TUSSIN G Butamirate citrate - 7.5mg/5ml 7.5mg/5ml Syrup, sugar free 154,862 L.L
A04AA01 ONDANSETRON RENAUDIN G Ondansetron (HCl dihydrate) - 4mg/2ml 4mg/2ml Injectable solution 2,964,517 L.L
B01AC04 CLOPI TAD G Clopidogrel (Bisulfate) - 75mg 75mg Tablet, film coated 911,125 L.L
B05BB02 SOLUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 158,587 L.L
C09DX01 LOTEVAN PLUS G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 857,372 L.L
D05AX52 BETA-CAL G Calcipotriol (monohydrate) - 50mcg/g, Betamethasone (dipropionate) - 0.5mg/g Gel 1,251,117 L.L
J01AA02 FARMODOXI G Doxycycline (hyclate) - 100mg 100mg Tablet 310,428 L.L
J01DH02 MIRAN G Meropenem (trihydrate) - 1g 1g Injectable powder for solution 819,744 L.L
J05AF10 ENTECAVIR ARROW G Entecavir - 1mg 1mg Tablet, coated 18,701,506 L.L
L01DB01 DOXORUBICINE EBEWE G Doxorubicin HCl - 10mg/5ml 10mg/5ml Injectable concentrated solution 428,686 L.L
M01AB05 EPARDEX G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 3,246,979 L.L
N03AX11 TOPIRAMATE ARROW G Topiramate - 50mg 50mg Tablet, film coated 765,990 L.L
P01AB01 METRONIDAZOLE FRESENIUS G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 1,866,597 L.L
A04AA01 ONDANSETRON VIANEX G Ondansetron (HCl) - 4mg/2ml 4mg/2ml Injectable solution 197,545 L.L
B01AC04 CLOPIDOGREL ARROW G Clopidogrel besylate - 75mg 75mg Tablet, film coated 658,483 L.L
B05BB02 5% DEXTROSE 0.45% SODIUM CHLORIDE INJECTION G Dextrose,H2O - 5g/100ml, Sodium chloride - 0.45g/100ml Injectable solution 179,272 L.L
C09DX01 VIOSTAN AM PLUS 160/5/12.5 G Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,196,020 L.L
D06AA04 MEPHICYCLINE DERMIQUE G Tetracycline HCl - 3% 3% Ointment 145,903 L.L
J01AA02 GRANUDOXY G Doxycycline (monohydrate) - 100mg 100mg Tablet, film-scored 282,207 L.L
J01DH02 ROPENEM 1000 BENTA G Meropenem (trihydrate) - 1000mg 1g Injectable powder for solution 995,723 L.L
J05AF10 ENTECAVIR BIOGARAN G Entecavir - 1mg 1mg Tablet, coated 19,080,319 L.L
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