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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
L04AX06 IMNOVID B Pomalidomide - 4mg 4mg Capsule, hard 417,741,356 L.L
N07XX07 FAMPYRA B Fampridine - 10mg 10mg Tablet, prolonged release 17,636,804 L.L
R05CB06 MUCOSOLVAN LA B Ambroxol HCl - 75mg 75mg Capsule 345,368 L.L
A04AA01 ZOFRAN B Ondansetron (HCl dihydrate) - 8mg 8mg Tablet, film coated 6,061,174 L.L
D04AB01 XYLOCAINE B Lidocaine - 10mg/spray dose 100mg/ml Spray 667,890 L.L
G03DA04 UTROGESTAN B Progesterone micronised natural - 200mg 200mg Capsule 587,259 L.L
L01XJ01 ERIVEDGE B Vismodegib - 150mg 150mg Capsule 465,368,012 L.L
N05AX12 ABILIFY MAINTENA B Aripiprazole - 400mg 400mg Injectable powder for suspension, prolonged release+solvent 29,491,998 L.L
N07XX07 FAMPYRA B Fampridine - 10mg 10mg Tablet, prolonged release 18,175,448 L.L
C01AA05 LANOXIN PG B Digoxin - 0.05mg/ml 0.05mg/ml Elixir 307,740 L.L
L01XK01 LYNPARZA B Olaparib - 100mg 100mg Tablet, film coated 230,789,350 L.L
N05AX13 INVEGA B Paliperidone - 9mg 9mg Tablet, extended release 5,825,557 L.L
N07XX08 VYNDAMAX B Tafamidis - 61mg 61mg Capsule 784,020,041 L.L
A10BD02 GLUCOVANCE B Metformin HCl - 500mg, Glibenclamide - 2.5mg Tablet, film coated 542,192 L.L
C01AA05 LANOXIN B Digoxin - 0.25mg 0.25mg Tablet 215,015 L.L
C09DX01 EXFORGE HCT B Valsartan - 160mg, Amlodipine - 5mg, Hydrochlorothiazide - 25mg Tablet, film coated 1,333,092 L.L
L01XK01 LYNPARZA B Olaparib - 150mg 150mg Tablet, film coated 230,789,350 L.L
N03AX09 LAMICTAL LIQUI-TABS B Lamotrigine - 5mg 5mg Tablet 361,046 L.L
N05AX13 INVEGA B Paliperidone - 3mg 3mg Tablet, extended release 5,386,121 L.L
V01AA STALORAL B Allergen extracts - 2 x 100IR ou IC/ml Solution 8,449,319 L.L
C01BC03 RYTMONORM B Propafenone HCl - 150mg 150mg Tablet, film coated 1,077,193 L.L
D04AB01 VERSATIS B Lidocaine - 5% 5% Patch 13,085,712 L.L
G03DA04 CRINONE B Progesterone - 8% 8% Gel 4,734,357 L.L
H05BA01 MIACALCIC B Calcitonin (salmon synthetic) - 100IU/ml 100IU/ml Injectable solution 1,720,118 L.L
L01XK04 TALZENNA B Talazoparib - 1mg 1mg Capsule 401,512,167 L.L
N05AX13 INVEGA B Paliperidone - 6mg 6mg Tablet, extended release 5,825,557 L.L
R05D 123 COLD AND FLU B Phenylephrine HCl - 5mg, Carbinoxamine HCl - 3mg, Caffeine anhydrous - 30mg, Codeine phosphate - 8mg, Acetaminophen - 325mg Tablet 409,552 L.L
V01AA STALORAL B Allergen extracts - 300 IR ou IC/ml Solution 6,598,267 L.L
A10BD02 GLUCOVANCE B Metformin HCl - 500mg, Glibenclamide - 5mg Tablet, film coated 746,412 L.L
B01AC04 PLAVIX B Clopidogrel (hydrogenosulfate) - 75mg 75mg Tablet, film coated 1,350,562 L.L
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