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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
L01CA04 NAVELBINE B Vinorelbine (ditartrate) - 20mg 20mg Capsule, soft gelatin 4,048,997 L.L
L04AX04 REVLIMID B Lenalidomide - 5mg 5mg Capsule 105,106,076 L.L
N06DX01 EBIXA B Memantine - 20mg 20mg Tablet, film coated 4,004,651 L.L
S01GX07 ALLERGODIL B Azelastine HCl - 0.5mg/ml 0.5mg/ml Drops solution 709,549 L.L
C09DB01 EXFORGE B Amlodipine - 10mg, Valsartan - 160mg Tablet, film coated 1,333,092 L.L
L01CA04 NAVELBINE B Vinorelbine (ditartrate) - 30mg 30mg Capsule, soft gelatin 6,072,824 L.L
M04AA01 ZYLORIC B Allopurinol - 300mg 300mg Tablet 302,365 L.L
C07BB07 CONCOR PLUS B Bisoprolol fumarate - 10mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,202,314 L.L
D01AE22 EXODERIL B Naftifine HCl - 10mg/g 1% Cream 345,368 L.L
H02AB04 DEPO MEDROL B Methylprednisolone acetate - 40mg/ml 40mg/ml Injectable suspension 182,763 L.L
J02AC04 NOXAFIL B Posaconazole - 100mg 100mg Tablet, gastroresistant 62,027,714 L.L
C07BB12 NEBILET PLUS B Nebivolol HCl - 5mg, Hydrochlorothiazide - 12.5mg Tablet, film coated 716,268 L.L
D01AE22 EXODERIL B Naftifine HCl - 10ml/ml 1% Solution 159,917 L.L
H02AB04 DEPO MEDROL B Methylprednisolone acetate - 80mg/2ml 80mg/2ml Injectable suspension 365,525 L.L
J02AC05 CRESEMBA B Isavuconazonium sulfate - 100mg 100mg Capsule, hard 69,290,804 L.L
N05AX08 RISPERDAL B Risperidone - 1mg/ml 1mg/ml Solution 1,377,439 L.L
S01GX09 PATANOL B Olopatadine (HCl) - 0.1% 0.1% Drops solution 873,498 L.L
A10BB12 AMARYL B Glimepiride - 2mg 2mg Tablet 233,829 L.L
C07BB12 NEBILET PLUS B Nebivolol HCl - 5mg, Hydrochlorothiazide - 25mg Tablet, film coated 716,268 L.L
J02AC05 CRESEMBA B Isavuconazonium sulfate - 200mg 200mg Injectable powder for concentrate for solution 38,436,952 L.L
N05AX08 RISPERDAL B Risperidone - 1mg/ml 1mg/ml Solution 1,377,439 L.L
C07DA06 MODUCREN B Amiloride HCl - 2.5mg, Timolol (maleate) - 10mg, Hydrochlorothiazide - 25mg Tablet 915,093 L.L
D01BA02 LAMISIL B Terbinafine HCl - 250mg 250mg Tablet, scored 813,025 L.L
J02AX04 CANCIDAS B Caspofungin (acetate) - 70mg 70mg Injectable concentrated powder for solution 31,611,335 L.L
N03AA02 GARDENAL B Phenobarbital - 100mg 100mg Tablet 120,946 L.L
C07FB07 CONCOR AM 2.5 B Bisoprolol fumarate - 2.5mg, Amlodipine besylate - 5mg Tablet, film coated 1,324,559 L.L
M04AA03 ADENURIC B Febuxostat - 120mg 120mg Tablet, film coated 2,184,704 L.L
N03AB02 EPANUTIN B Phenytoin sodium - 100mg 100mg Capsule 739,113 L.L
N07AA02 MESTINON B Pyridostigmine bromide - 60mg 60mg Tablet, sugar coated 3,090,838 L.L
C07FB07 CONCOR AM 5 B Bisoprolol fumarate - 5mg, Amlodipine besylate - 5mg Tablet, film coated 1,324,559 L.L
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    167
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