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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
A08AA62 CONTRAVE B Naltrexone Hydrochloride - 8mg, Bupropion Hydrochloride - 90mg Tablet, prolonged release 11,653,550 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.25mcg 0.25mcg Capsule 1,138,235 L.L
B02BX01 DICYNONE B Etamsylate - 500mg 500mg Capsule 1,311,590 L.L
C05AX05 PROCTO GLYVENOL B Lidocaine HCl - 2g/100g, Tribenoside - 5g/100g Cream 405,840 L.L
D10AD53 EPIDUO B Adapalene - 0.1%, Benzoyl peroxide - 2.5% Gel 2,088,331 L.L
J01DC02 ZINNAT B Cefuroxime (axetil) - 500mg 500mg Tablet, film coated 908,603 L.L
L01AA01 ENDOXAN B Cyclophosphamide (monohydrate) - 500mg 500mg Injectable powder for solution 764,646 L.L
L01EX02 NEXAVAR B Sorafenib - 200mg 200mg Tablet, film coated 82,858,698 L.L
L04AA32 OTEZLA B Apremilast - 4x10mg- 4x20mg- 19x30mg Tablet, film coated 34,751,325 L.L
N02BE01 DOLIPRANE B Paracetamol - 1000mg 1000mg Tablet 120,946 L.L
N04BC09 NEUPRO B Rotigotine - 6mg/24h 6mg/24h Patch 9,427,593 L.L
A08AB01 XENICAL B Orlistat - 120mg 120mg Capsule 4,036,903 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.5mcg 0.5mcg Capsule 943,377 L.L
C05BA53 CONTRACTUBEX B Allantoin - 1g/100g, Cepae - 10g/100g, Heparin - 5000IU/100g Gel 498,566 L.L
D10AD53 EPIDUO FORTE B Adapalene - 0.3%, Benzoyl peroxide - 2.5% Gel 2,201,214 L.L
L01AA06 HOLOXAN B Ifosfamide - 1g 1g Injectable powder for solution 3,586,850 L.L
L01EX03 VOTRIENT B Pazopanib HCl - 400mg 400mg Tablet, film coated 77,725,025 L.L
N02BE01 EFFERALGAN B Paracetamol - 1g 1g Tablet, film coated 129,009 L.L
N04BC09 NEUPRO B Rotigotine - 8mg/24h 8mg/24h Patch 12,394,936 L.L
S01AA13 FUCITHALMIC VISCOUS B Fusidic acid - 10mg/g 1% Drops 373,588 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 0.5mcg 0.5mcg Capsule 942,034 L.L
B02BX05 REVOLADE B Eltrombopag Olamine - 25mg 25mg Tablet, film coated 75,701,015 L.L
C05BA53 CONTRACTUBEX B Allantoin - 1g/100g, Cepae - 10g/100g, Heparin - 5,000IU/100g Gel 1,183,925 L.L
C09CA06 ATACAND B Candesartan cilexetil - 16mg 16mg Tablet 705,517 L.L
C10AA07 CRESTOR B Rosuvastatin (calcium) - 20mg 20mg Tablet, film coated 804,962 L.L
L01EX03 VOTRIENT B Pazopanib HCl - 200mg 200mg Tablet, film coated 42,465,160 L.L
L04AA32 OTEZLA B Apremilast - 30mg 30mg Tablet, film coated 49,829,454 L.L
N06AX16 EFEXOR XR B Venlafaxine (HCl) - 150mg 150mg Capsule, sustained release 817,056 L.L
R03AK08 INUVER B Formoterol fumarate - 6mcg/dose, Beclometasone dipropionate - 100mcg/dose Inhalation solution 3,493,991 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Drops solution 1,343,843 L.L
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