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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
M05BA04 OREK G Alendronate - 70mg 70mg Tablet, coated 2,404,838 L.L
M05BA04 OSTEOMED G Alendronic acid (sodium alendronate) - 70mg 70mg Tablet, scored 950,929 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.25mcg 0.25mcg Capsule 1,138,235 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.5mcg 0.5mcg Capsule 943,377 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.5mcg 0.5mcg Capsule 942,034 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 1mcg 1mcg Capsule 3,735,882 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 2,218,684 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 4,219,665 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Drops solution 1,343,843 L.L
J01GB06 ORLOBIN G Amikacin (sulfate) - 500mg/2ml 500mg/2ml Injectable solution 329,241 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 1g 1,000mg Tablet, film coated 683,273 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 223,078 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 750mg 750mg Tablet, film coated 499,372 L.L
L04AA32 OTEZLA B Apremilast - 30mg 30mg Tablet, film coated 49,829,454 L.L
L04AA32 OTEZLA B Apremilast - 4x10mg- 4x20mg- 19x30mg Tablet, film coated 34,751,325 L.L
N01BB58 ORABLOC G Articaine HCl - 4%, Epinephrine (tartrate) - 1/100.000 Injectable solution 2,308,721 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 10mg 10mg Tablet 966,287 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 20mg 20mg Tablet 1,091,712 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 40mg 40mg Tablet 1,405,275 L.L
C10AA05 ORVASTA G Atorvastatin - 10mg 10mg Tablet, film coated 834,526 L.L
C10BA05 OTOREZA G Atorvastatin - 10mg, Ezetimibe - 10mg Tablet, film coated 908,438 L.L
C10BA05 OTOREZA 10/10 G Atorvastatin - 10mg, Ezetimibe - 10mg Tablet, film coated 454,219 L.L
C10AA05 ORVASTA G Atorvastatin - 20mg 20mg Tablet, film coated 920,532 L.L
C10BA05 OTOREZA 10MG/20MG G Atorvastatin - 20mg, Ezetimibe - 10mg Tablet, film coated 858,715 L.L
C10AA05 ORVASTA G Atorvastatin - 40mg 40mg Tablet, film coated 1,170,487 L.L
C10BA05 OTOREZA 10MG/40MG G Atorvastatin - 40mg, Ezetimibe - 10mg Tablet, film coated 1,144,954 L.L
L04AA37 OLUMIANT B Baricitinib - 2mg 2mg Tablet, film coated 68,053,864 L.L
L04AA37 OLUMIANT B Baricitinib - 4mg 4mg Tablet, film coated 68,053,864 L.L
C09AA01 ORBACE G Captopril - 25mg 25mg Tablet 522,179 L.L
C09AA01 ORBACE G Captopril - 50mg 50mg Tablet 949,649 L.L
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