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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
C09DB02 OLMENOR COMBI G Olmesartan medoxomil - 40mg, Amlodipine - 5mg Tablet, film coated 772,709 L.L
M05BX OSSOPAN B Osseine-hydroxyapatite complex - 800mg 800mg Tablet, film coated 1,142,266 L.L
A04AA01 ONDAKEY G Ondansetron (HCl dihydrate) - 8mg 8mg Tablet, film coated 2,241,529 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,067,011 L.L
A04AA01 ONDANSETRON MEDIS G Ondansetron (HCl dihydrate) - 8mg 8mg Tablet, film coated 748,520 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 10mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,067,011 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 20mg, Amlodipine (besylate) - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,037,446 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 5mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,067,011 L.L
C09DX03 OLMENOR TRIPLE G Olmesartan medoxomil - 40mg, Amlodipine (besylate) - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 1,067,011 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 750mg 750mg Tablet, film coated 480,350 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 1g 1,000mg Tablet, film coated 657,246 L.L
R06AX ORADUS BETA G Desloratadine - 5mg, Betamethasone - 0.6mg Tablet, film coated 497,862 L.L
A05AA04 OCALIVA B Obeticholic acid - 10mg 10mg Tablet, film coated 224,503,943 L.L
A05AA04 OCALIVA B Obeticholic acid - 5mg 5mg Tablet, film coated 224,503,943 L.L
C10AA05 ORVASTA G Atorvastatin - 10mg 10mg Tablet, film coated 834,526 L.L
G04CA02 OMNIC OCAS B Tamsulosin HCl - 0.4mg 0.4mg Tablet, film coated, prolonged release 866,778 L.L
J01MA01 OFLACIN G Ofloxacin - 200mg 200mg Tablet, film-scored 602,041 L.L
J01MA01 OFLOMED G Ofloxacin - 200mg 200mg Tablet, film-scored 601,530 L.L
M01AB05 OLFEN-50 G Diclofenac sodium - 50mg 50mg Tablet, gastroresistant 248,611 L.L
N05AH03 OLANZAX 5 G Olanzapine - 5mg 5mg Tablet, mouth dissolving 1,316,966 L.L
N05AH03 OLIZAX 5 G Olanzapine - 5mg 5mg Tablet, mouth dissolving 1,466,580 L.L
N05AH03 OLANZAX 10 G Olanzapine - 10mg 10mg Tablet, mouth dissolving 2,329,327 L.L
N05AH03 OLIZAX 10 G Olanzapine - 10mg 10mg Tablet, mouth dissolving 2,598,096 L.L
A04AA01 ONDANSETRON ARROW G Ondansetron - 8mg 8mg Tablet, orodispersible 1,280,682 L.L
A04AA01 ONZETRAN OD G Ondansetron - 8mg 8mg Tablet, orodispersible 1,023,880 L.L
M01AB05 OLFEN-75 SR G Diclofenac sodium - 75mg 75mg Tablet, prolonged release 326,554 L.L
M05BA04 OSTEOMED G Alendronic acid (sodium alendronate) - 70mg 70mg Tablet, scored 950,929 L.L
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