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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
B01AB05 HEPAXANE 4000IU BioTech Enoxaparin sodium - 40mg/0.4ml 40mg/0.4ml Injectable solution 4,063,780 L.L
D07CA01 HYDROMYCINE G Neomycin sulfate - 0.005g/g, Hydrocortisone acetate - 0.01g/g Cream 238,052 L.L
G04BE08 HEROX G Tadalafil - 20mg 20mg Tablet, film coated 248,611 L.L
G04BE08 HEROX G Tadalafil - 20mg 20mg Tablet, film coated 929,939 L.L
J07BC01 HEPATITIS-B VACCINE (r DNA) PAEDIATRIC G Hepatitis B, purified surface antigen adsorbed on aluminium hydroxide (Al+++) (0.25mg to 0.40mg) - 10mcg/0.5ml 10mcg/0.5ml Injectable suspension 323,866 L.L
G04BE08 HEROX G Tadalafil - 5mg 5mg Tablet, film coated 1,416,410 L.L
J01DB04 HIKMA CEFAZOLIN G Cefazolin (sodium) - 1g 1,000mg Injectable solution 215,015 L.L
A02BC01 HYPOSEC G Omeprazole - 20mg 20mg Capsule 659,827 L.L
A02BC01 HYPOSEC G Omeprazole - 20mg 20mg Capsule 1,478,227 L.L
A07EA02 HEMORRANE G Hydrocortisone acetate - 10mg/g 10mg/g Ointment 710,893 L.L
N05AD01 HALOPERIDOL G Haloperidol - 5mg 5mg Tablet 276,448 L.L
C03DA04 HEPERONA 25 G Eplerenone - 25mg 25mg Tablet, coated 2,116,552 L.L
N05AD01 HALOPERIDOL G Haloperidol - 2mg 2mg Tablet 252,130 L.L
N05AD01 HALOPERIDOL G Haloperidol - 10mg 10mg Tablet 339,160 L.L
N05AD01 HALOPERIDOL G Haloperidol - 20mg 20mg Tablet 339,160 L.L
C03DA04 HEPERONA 50 G Eplerenone - 50mg 50mg Tablet, coated 2,150,148 L.L
C05AX HEMOCARE G Bismuth subgallate - 100mg, Zinc oxide - 100mg, Lidocaine - 60mg Suppository 588,731 L.L
A11CC05 HI DEE G Vitamin D3 - 10000IU 10000IU Capsule, soft gelatin 862,747 L.L
A11CC05 HI DEE G Vitamin D3 - 50000IU 50000IU Capsule, soft gelatin 518,723 L.L
D11AX01 HAIRGAINE 5 G Minoxidil - 5% 5% Solution 1,963,354 L.L
D11AX01 HAIRGROW G Minoxidil - 5% 5% Solution 1,061,636 L.L
N02BE51 HUMACE PLUS G Paracetamol - 500mg, Aceclofenac (potassium) - 200mg Tablet 575,165 L.L
A11CC05 HI DEE G Vitamin D3 - 5000IU 5000IU Capsule, soft gelatin 740,457 L.L
L01BC05 HAXANIT G Gemcitabine (HCl) - 200mg 200mg Injectable lyophilised powder 1,411,035 L.L
A11CC06 HIDROFEROL G Calcifediol - 0.266mg 0.266mg Capsule, soft 1,316,966 L.L
L01BC05 HAXANIT G Gemcitabine (HCl) - 1g 1g Injectable lyophilised powder 6,829,408 L.L
R05CA12 HEDERAL G Dried Ivy leaf extract (Hedera Helix) - 99mg/5ml 99mg/5ml Drops solution 384,339 L.L
R05CA12 HEDERAL G Dried Ivy leaf extract - 37mg/5ml 37mg/5ml Syrup 309,084 L.L
R05CA12 HEDECTON COUGH G Ivy leaf soft extract - 40mg/5ml Syrup 467,657 L.L
A03AX HEPABYL G Sorbitol - 2.5g/5ml, Diisopromine - 0.02g/5ml Liquid 238,052 L.L
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