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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
L03AA02 NEUTROMAX BioTech Filgrastim - 300mcg/ml 300mcg/ml Injectable solution 2,553,301 L.L
L03AA02 NEUPOGEN BioTech Filgrastim - 300mcg/0.5ml 300mcg/0.5ml Injectable solution 5,250,393 L.L
L03AA02 NIVESTIM BioTech Filgrastim - 30MIU/0.5ml 30MIU/0.5ml Injectable solution 17,110,745 L.L
L03AA13 NEULASTIM BioTech Pegfilgrastim - 6mg/0.6ml 6mg/0.6ml Injectable solution 56,925,965 L.L
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
A10AB05 NOVORAPID FLEXPEN BioTech Insulin aspart - 100IU/ml 100IU/ml Injectable solution 3,123,090 L.L
A10AD05 NOVOMIX 30 BioTech Insulin aspart - 30%, Insulin aspart protamine - 70% 100IU/ml Injectable suspension 4,264,012 L.L
A10AD05 NOVOMIX 30 BioTech Insulin aspart - 30%, Insulin aspart protamine - 70% 100IU/ml Injectable suspension 4,264,012 L.L
A10AD05 NOVOMIX 30 BioTech Insulin aspart - 30%, Insulin aspart protamine - 70% 100IU/ml Injectable suspension 4,264,012 L.L
H01AC01 NORDITROPIN NORDIFLEX BioTech Somatropin recombinant - 5mg/1.5ml 5mg/1.5ml Injectable solution 7,582,922 L.L
H01AC01 NORDITROPIN NORDIFLEX BioTech Somatropin recombinant - 10mg/1.5ml 10mg/1.5ml Injectable solution 14,532,052 L.L
B02BD08 NOVOSEVEN RT BioTech Eptacog alfa (activated) recombinant - 1mg 1mg (50KIU) Injectable powder for solution+diluent L.L
B02BX04 NPLATE BioTech Romiplostim - 250mcg 250mcg Injectable powder for solution L.L
M03AX01 NEURONOX BioTech Clostridium botulinum type A neurotoxin complex - 100units 100units Injectable lyophilised powder for solution 13,011,437 L.L
M03AX01 NEURONOX BioTech Clostridium botulinum type A neurotoxin complex - 200units 200units Injectable lyophilised powder for solution 25,175,058 L.L
M03AX01 NEURONOX BioTech Clostridium botulinum type A neurotoxin complex - 50units 50units Injectable lyophilised powder for solution 8,904,323 L.L
C09AA05 NORMOPRIL G Ramipril - 10mg 10mg Tablet 599,354 L.L
J05AG01 NEPINE G Nevirapine - 200mg 200mg Tablet 5,921,678 L.L
N02BF02 NERVAX G Pregabalin - 75mg 75mg Capsule 513,348 L.L
N07AA01 NEOSTIGMINE RENAUDIN G Neostigmine - 5mg/5ml 5mg/5ml Injectable solution 2,460,576 L.L
N02BF02 NEUREXAL G Pregabalin - 75mg 75mg Capsule 335,577 L.L
N02BF02 NEUREXAL G Pregabalin - 75mg 75mg Capsule 637,365 L.L
J05AP08 NUCLEOBUVIR G Sofosbuvir - 400mg 400mg Tablet, film coated 50,670,440 L.L
N02BF02 NEUREXAL G Pregabalin - 25mg 25mg Capsule 321,754 L.L
N02BG06 NEO-PAN G Nefopam HCl - 20mg/2ml 20mg/2ml Injectable solution 483,783 L.L
A07AX03 NIFUNAL G Nifuroxazide - 200mg 200mg Capsule, hard 217,702 L.L
A02BC01 NEOOPRAZOLE G Omeprazole - 20mg 20mg Capsule, hard, gastro-resistant 407,184 L.L
N03AF01 NEUROTOP RETARD G Carbamazepine - 600mg 600mg Tablet, prolonged release 1,569,608 L.L
M09AX NUCLEO C.M.P. FORTE G UTP+UDP+UMP - 3mg, CMP - 5mg Capsule 448,843 L.L
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