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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
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 2,025,171 L.L
J01DD15 OMNICEF B Cefdinir - 125mg/5ml 125mg/5ml Powder for suspension 1,189,301 L.L
R03AC18 ONBREZ BREEZHALER B Indacaterol maleate - 150mcg 150mcg Capsule, inhalation 2,284,532 L.L
L01EX09 OFEV B Nintedanib - 150mg 150mg Capsule, soft L.L
L01EX09 OFEV B Nintedanib - 150mg 150mg Capsule, soft 201,946,695 L.L
J02AC01 ORAMAX G Fluconazole - 150mg 150mg Capsule 170,668 L.L
A03AX13 OVOL FOR GAZ B Simethicone - 180mg 180mg Capsule, liquid gel 241,892 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 1mcg 1mcg Capsule 3,735,882 L.L
A10BJ06 OZEMPIC B Semaglutide - 1mg 1mg Injectable solution 10,927,526 L.L
A10BB12 ORBIDE G Glimepiride - 1mg 1mg Tablet 207,336 L.L
J06BA02 OCTAGAM BioHuman Human normal immunoglobulin G - 50mg/ml 2.5g/50ml Injectable solution 19,540,934 L.L
J01MA01 OFLACIN G Ofloxacin - 200mg 200mg Tablet, film-scored 602,041 L.L
J01MA01 OFLOMED G Ofloxacin - 200mg 200mg Tablet, film-scored 601,530 L.L
B05BC01 OSMITOL G Mannitol - 20g/100ml 20g/100ml Injectable solution 579,064 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 20mg 20mg Tablet 1,091,712 L.L
C10AA05 ORVASTA G Atorvastatin - 20mg 20mg Tablet, film coated 920,532 L.L
A02BC01 OMEDAR G Omeprazole - 20mg 20mg Tablet, enteric coated 18,087,352 L.L
A02BC01 OMEPRAL G Omeprazole - 20mg 20mg Capsule, delayed release 213,735 L.L
A02BC01 OMEPRAZOLE PHARMADEX G Omeprazole - 20mg 20mg Capsule 415,951 L.L
A02BC01 OMEPRAZOLE PHARMADEX G Omeprazole - 20mg 20mg Capsule 15,757,784 L.L
A02BC01 OMEZOL BENTA G Omeprazole - 20mg 20mg Capsule 550,336 L.L
A02BC01 OMEZOL BENTA G Omeprazole - 20mg 20mg Capsule 317,403 L.L
A02BC01 OMEPRAL G Omeprazole - 20mg 20mg Powder for suspension 712,876 L.L
N05AH03 OLANZAMED G Olanzapine - 20mg 20mg Tablet 3,941,938 L.L
C09CA08 OLMETEC B Olmesartan medoxomil - 20mg 20mg Tablet, film coated 888,280 L.L
C09CA08 OLMENOR G Olmesartan medoxomil - 20mg 20mg Tablet, film coated 667,890 L.L
N06AB03 OXETINE 20 G Fluoxetine (HCl) - 20mg 20mg Tablet, coated 362,837 L.L
N02AA05 OXYNORM B Oxycodone HCl - 20mg 20mg Capsule, hard 7,634,958 L.L
B02BD02 OCTANATE BioHuman Coagulation Factor VIII - 250IU 250IU Injectable lyophilised powder for solution+diluent 13,247,110 L.L
G03GA08 OVITRELLE BioHuman Choriogonadotropin Alfa - 250mcg/0.5ml 250mcg/0.5ml Injectable solution 4,145,754 L.L
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