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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
A06AD61 SOFLAX G Lactose - less than 6g/100ml, Galactose - less than 11g/100ml, Lactulose - 67g/100ml Solution 258,018 L.L
N06AX27 SPRAVATO B Esketamine - 28mg/device 28mg/device Solution 25,122,440 L.L
N06AX27 SPRAVATO B Esketamine (HCl) - 28mg 28mg/device Solution 66,978,978 L.L
N06AX27 SPRAVATO B Esketamine (HCl) - 28mg 28mg/device Solution 44,561,381 L.L
N06BX06 SOMAZINA B Citicoline - 1000mg/sachet 1000mg/sachet Solution 974,286 L.L
L04AD01 SANDIMMUN NEORAL B Ciclosporin - 100mg/ml 100mg/ml Solution 8,264,592 L.L
S02AA15 SEPTOCIPRO OTICO B Ciprofloxacine (HCl) - 1mg/0.5ml 1mg/0.5ml Solution 473,033 L.L
V01AA STALORAL B Allergen extracts - 2 x 100IR ou IC/ml Solution 8,449,319 L.L
V01AA STALORAL B Allergen extracts - 300 IR ou IC/ml Solution 6,598,267 L.L
V01AA STALORAL B Allergen extracts - 10-100-100 IR ou IC/ml 10-100-100 IR ou IC/ml Solution 9,129,688 L.L
V01AA STALORAL B Allergen extracts - 10-300 IR ou IC/ml 10-300 IR ou IC/ml Solution 7,206,963 L.L
A07BC05 SMECTALIA B Diosmectite - 3g/sachet 3g/sachet Powder for suspension 935,570 L.L
A07BC05 SMECTALIA STRAWBERRY B Diosmectite - 3g/sachet 3g/sachet Powder for suspension 935,570 L.L
J01DD08 SUPRAX 100 B Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Powder for suspension 581,884 L.L
J01DD08 SUPRAX 100 B Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Powder for suspension 581,884 L.L
J01DD08 SUPRAX 100 B Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Powder for suspension 1,166,455 L.L
J01DD08 SUPRAX 100 B Cefixime (trihydrate) - 100mg/5ml 100mg/5ml Powder for suspension 1,166,455 L.L
V03AE02 SEVELAMER CARBONATE ARROW G Sevelamer - 2.4g 2.4g Powder for suspension 12,969,932 L.L
M01AE03 SOLKET G Ketoprofen Lysine salt - 80mg 80mg Powder for solution 636,981 L.L
D06BA05 SULFANILAMIDE G Sulfanilamide - 12g 12g Powder 151,022 L.L
A04AA02 SANCUSO G Granisetron - 3.1mg/24h 3.1mg/24h Patch 7,590,728 L.L
C05AA01 SINAHEAL-H G Hydrocortisone acetate - 0.275g/100g, Lidocaine - 5g/100g, Zinc oxide - 18g/100g, Aluminium Subacetate - 3.5g/100g Ointment 330,585 L.L
P03AX01 SPIDOGALE G Benzyl benzoate - 10g/100ml, Sulfur colloïdal - 5g/100ml Lotion 207,336 L.L
J07AL02 SYNFLORIX B Polysaccharide from each of 10 capsular types of pneumococcus (conjugated to carrier proteins) adsorbed onto aluminium phosphate - 1mcg/0.5ml, Polysaccharide of serotypes 41,2, 18C1,3 and 19F1,4 - 3mcg/0.5ml, 1 adsorbed onto aluminium phosphate - 0.5mg Al3+, 2 conjugated to protein D (derived from NTHi) carrier protein - ~ 13mcg, 3 conjugated to tetanos toxoid carrier protein - ~ 8mcg, 4 conjugated to diphteria toxoid carrier protein - ~ 5mcg Injectable suspension 4,675,228 L.L
A10BJ02 SAXENDA BioTech Liraglutide - 6mg/ml 6mg/ml Injectable solution 16,747,035 L.L
L04AC05 STELARA BioTech Ustekinumab - 90mg 90mg Injectable solution L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 171,228 L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION USP G Glucose - 5% 5% Injectable solution 158,587 L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 171,228 L.L
B05CX01 SERUFLEX DEXTROSE 5% INJECTION, USP G Glucose - 5% 5% Injectable solution 193,062 L.L
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