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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
R05DB13 TUSSIN G Butamirate citrate - 7.5mg/5ml 7.5mg/5ml Syrup, sugar free 154,862 L.L
A04AA01 TRONDAMET G Ondansetron (HCl) - 8mg/4ml 8mg/4ml Injectable solution 2,027,858 L.L
A10BD07 SAGIMET G Metformin HCl - 500mg, Sitagliptin (HCl monohydrate) - 50mg Tablet, film coated 1,432,536 L.L
B01AC04 PLAVINOR-75 G Clopidogrel - 75mg Tablet, film coated Tablet, film coated 1,112,702 L.L
B05BB02 DEXTROSE 5% & SODIUM CHLORIDE 0.45% G Sodium chloride - 0.45g/100ml, Dextrose, H2O - 5g/100ml Injectable solution 240,255 L.L
C01CA03 ? NORADRENALINE G Norepinephrine tartrate - 8mg/4ml 8mg/4ml Injectable solution 330,201 L.L
C08DB01 APO-DILTIAZ G Diltiazem HCl - 60mg 60mg Tablet 545,600 L.L
D06AX PENICILLIN DERMIC OINTMENT G Penicillin - 5,000IU 5,000IU Ointment 80,631 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 ENTRILIV G Entecavir - 1mg 1mg Tablet, film coated 19,165,898 L.L
L01DB01 DOXORUBICINE EBEWE G Doxorubicin HCl - 2mg/ml 50mg/25ml Injectable concentrated solution 1,804,780 L.L
L01XX35 ANAGRELIDE BIOGARAN G Anagrelide - 0.5mg 0.5mg Capsule 15,754,068 L.L
M01AB05 OLFEN-50 G Diclofenac sodium - 50mg 50mg Tablet, gastroresistant 248,611 L.L
M05BA08 SIMPLA G Zoledronic acid - 5mg/100ml 5mg/100ml Injectable solution 13,071,402 L.L
P01AB01 METRONIDAZOLE B. BRAUN G Metronidazole - 500mg/100ml 500mg/100ml Injectable solution 102,132 L.L
A04AA01 ? ONDANSETRON USP G Ondansetron - 8mg/4ml 8mg/4ml Injectable solution 447,948 L.L
B01AC04 THROMBO G Clopidogrel - 75mg 75mg Tablet, film coated 764,646 L.L
B05BB02 DEXTROSE 5% SODIUM CHLORIDE 0.45% INJECTION, USP G Sodium chloride - 0.45%, Glucose - 5% Injectable solution 193,062 L.L
C01CA03 NORADRENALINE HIKMA G Noradrenaline bitartrate - 4mg/4ml 4mg/4ml Injectable solution 1,279,338 L.L
C08DB01 ZALDEM G Diltiazem HCl - 60mg 60mg Tablet, scored 199,657 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 10mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,067,011 L.L
J01AA02 GRANUDOXY G Doxycycline (monohydrate) - 100mg 100mg Tablet, film-scored 282,207 L.L
J05AF10 HEPCAVIR 1 G Entecavir monohydrate - 1mg 1mg Tablet, film coated 18,998,515 L.L
M01AB05 PRIMAFENAC G Diclofenac sodium - 50mg 50mg Tablet, enteric coated 223,974 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
R05DB21 PRIVITUSS G L-Cloperastine - 708mg/100ml 708mg/100ml Suspension 801,186 L.L
V03AB35 PLIBADEX G Sugammadex - 500mg/5ml 500mg/5ml Injectable solution 94,888,975 L.L
A04AA01 NOZAMET G Ondansetron - 8mg 8mg Film, orodispersible 6,075,448 L.L
    ...
    164
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