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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
G04CA04 SILOSIN B Silodosine - 4mg 4mg Capsule 1,251,693 L.L
R03BB01 ATROVENT N B Ipratropium bromide - 20mcg/actuation 20mcg/actuation Inhalation aerosol metered dose 428,686 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 4,219,665 L.L
B02BX01 DICYNONE B Etamsylate - 250mg/2ml 250mg Injectable solution 482,439 L.L
C05BX01 DOXIUM B Calcium dobesilate - 500mg 500mg Capsule 2,151,492 L.L
M02AA10 FASTUM B Ketoprofen - 2.5g/100g 2.5% Gel 177,387 L.L
S01CA01 NETILDEX B Dexamethasone - 0.1%, Netilmicin - 0.3% Drops solution 752,552 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 1mcg 1mcg Capsule 3,735,882 L.L
B02BX01 DICYNONE B Etamsylate - 500mg 500mg Capsule 1,311,590 L.L
C05BX01 DOXIUM B Calcium dobesilate - 500mg 500mg Capsule 1,323,685 L.L
D10AF51 DUAC ONCE DAILY B Clindamycin (phosphate) - 1%, Benzoyl peroxide - 5% Gel 1,658,302 L.L
M02AA10 FASTUM B Ketoprofen - 2.5g/100g 2.5% Gel 337,304 L.L
R03BB04 SPIRIVA WITH HANDIHALER B Tiotropium bromide - 18mcg 18mcg Capsule, inhalation 3,179,531 L.L
C05BX51 DOXIPROCT B Calcium dobesilate - 4%, Lidocaine HCl - 2% Ointment 610,104 L.L
C09CA07 MICARDIS B Telmisartan - 40mg 40mg Tablet 760,615 L.L
D10AX03 SKINOREN B Azelaic acid - 0.2g/g 0.2g/g Cream 722,987 L.L
G04CA04 SILOSIN B Silodosine - 8mg 8mg Capsule 1,927,454 L.L
S01EA05 ALPHAGAN P B Brimonidine tartrate - 1.5mg/ml 0.15% Drops solution 1,001,163 L.L
A08AA01 LOMAIRA B Phentermine Hydrochloride - 8mg 8mg Tablet 6,138,673 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.25mcg 0.25mcg Capsule 1,138,235 L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 25mg 25mg Tablet, film coated 75,701,015 L.L
C05BX51 DOXIPROCT PLUS B Calcium dobesilate - 4%, Dexamethasone acetate - 0.0025%, Lidocaine HCl - 2% Ointment 489,159 L.L
R03BB04 SPIRIVA RESPIMAT B Tiotropium bromide - 2.5mcg/dose 2.5mcg/dose Inhalation solution 3,000,800 L.L
S01EA05 ALPHAGAN P B Brimonidine tartrate - 1.5mg/ml 0.15% Drops solution 1,001,163 L.L
A08AA62 CONTRAVE B Naltrexone Hydrochloride - 8mg, Bupropion Hydrochloride - 90mg Tablet, prolonged release 11,653,550 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.5mcg 0.5mcg Capsule 943,377 L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 50mg 50mg Tablet, film coated 69,643,660 L.L
C05CA03 DIOVENOR 600 B Diosmin - 600mg 600mg Tablet, film coated 1,089,856 L.L
A08AB01 XENICAL B Orlistat - 120mg 120mg Capsule 4,036,903 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.5mcg 0.5mcg Capsule 942,034 L.L
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