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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
H05AA02 OSTEOFORTIL BioTech Teriparatide - 250mcg/ml 250mcg/ml Injectable solution 16,963,499 L.L
J01DD15 OMNICEF B Cefdinir - 250mg/5ml 250mg/5ml Powder for suspension 3,670,034 L.L
J01CA04 OSPAMOX G Amoxicillin (trihydrate) - 250mg/5ml 250mg/5ml Powder for suspension 223,078 L.L
C09AA01 ORBACE G Captopril - 25mg 25mg Tablet 522,179 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 2,218,684 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Injectable solution 4,219,665 L.L
A11CC03 ONE-ALPHA B Alfacalcidol - 2mcg/ml 2mcg/ml Drops solution 1,343,843 L.L
L04AA37 OLUMIANT B Baricitinib - 2mg 2mg Tablet, film coated 68,053,864 L.L
A10BB12 ORBIDE G Glimepiride - 2mg 2mg Tablet 209,895 L.L
J01DD15 OMNICEF B Cefdinir - 300mg 300mg Capsule 2,238,842 L.L
J01DD15 OMNICEF 300 B Cefdinir - 300mg 300mg Capsule 2,238,842 L.L
L04AA36 OCREVUS BioTech Ocrelizumab - 300mg/10ml 300mg/10ml Injectable concentrate for solution 547,517,314 L.L
L04AA32 OTEZLA B Apremilast - 30mg 30mg Tablet, film coated 49,829,454 L.L
M05BA07 OSTERAL G Risedronate sodium - 35mg 35mg Tablet, film coated 511,940 L.L
A10BB12 ORBIDE G Glimepiride - 3mg 3mg Tablet 351,959 L.L
S01AE01 OPTIFLOX G Ofloxacin - 3mg/ml 3mg/ml Drops suspension 143,791 L.L
S02AA16 OFLOMED G Ofloxacin - 3mg/ml 3mg/ml Drops solution 317,403 L.L
C10AA05 ORBALIP G Atorvastatin (calcium) - 40mg 40mg Tablet 1,405,275 L.L
C10AA05 ORVASTA G Atorvastatin - 40mg 40mg Tablet, film coated 1,170,487 L.L
A02BC01 OMEPRAL G Omeprazole - 40mg 40mg Capsule, delayed release 499,142 L.L
A02BC01 OMEPRAZOLE ARROW G Omeprazole - 40mg 40mg Injectable powder for solution 454,219 L.L
A02BC01 OMEPRAZOLE VIANEX G Omeprazole (sodium) - 40mg 40mg Injectable powder for solution+diluent 467,657 L.L
A02BC01 OMEPRAZOLE-ORBUCELL G Omeprazole (sodium) - 40mg 40mg Injectable solution 3,839,550 L.L
C09CA08 OLMETEC B Olmesartan medoxomil - 40mg 40mg Tablet, film coated 920,532 L.L
C09CA08 OLMENOR G Olmesartan medoxomil - 40mg 40mg Tablet, film coated 721,643 L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution 51,234,726 L.L
A03AX13 OVOL B Simethicone - 40mg/ml 40mg/ml Drops 233,829 L.L
L01FD01 OGIVRI BioTech Trastuzumab - 440mg 440mg Injectable lyophilised powder 80,027,615 L.L
L04AA37 OLUMIANT B Baricitinib - 4mg 4mg Tablet, film coated 68,053,864 L.L
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