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اين يمكنك التبليغ عن الاحداث الجانية للأدوية واللقاحات

 
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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التصنيف العلاجي الاسم أساسي / جنيسي التركيبة العلمية العيار الشكل الصيدلاني سعر المبيع من العموم
A10AE54 SULIQUA BioTech Insulin glargine - 100IU/ml, Lixisenatide - 33mcg/ml Injectable solution 7,975,793 L.L
R05C SULDEX G Caffein anyhdrous - 0.216g, Antipyrine - 0.972g, Potassium sulfaguaiacolate - 1.44g Syrup 152,302 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 2mg, Naloxone HCl - 0.5mg Tablet, sublingual 1,473,590 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 8mg, Naloxone HCl - 2mg Tablet, sublingual 7,382,584 L.L
N07BC51 SUBOXONE G Buprenorphine HCl - 16mg, Naloxone HCl - 4mg Tablet, sublingual 14,284,125 L.L
B05 SOLUFLEX POTASSIUM CHLORIDE 40meq/l SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9%, Potassium chloride - 40meq/l Injectable solution 293,041 L.L
A03AX SPASMO-DIGESTIN B Simethicone - 30mg, Dicyclomine HCl - 5mg, Sodium dihydrocholate - 10mg, Sanzyme 3500 - 36mg, Papain - 100mg Tablet, enteric coated 260,705 L.L
B05 SOLUFLEX POTASSIUM CHLORIDE 20meq/l SODIUM CHLORIDE 0.9% INJECTION USP G Sodium chloride - 0.9%, Potassium chloride - 20meq/l Injectable solution 232,134 L.L
A03AX12 SPASFON B Phloroglucinol hydrate - 80mg, Trimethylphloroglucinol - 80mg Tablet, coated 278,175 L.L
S03AA30 SULFACHLOR G Sulfacetamide sodium - 110mg/ml, Chloramphenicol - 5mg/ml Drops solution 202,216 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
B05BA10 SMOFKABIVEN G Glucose monohydrate - 462mg, Soya-bean oil, refined - 60mg, Triglycerides, Medium Chain - 60mg, Olive oil, refined - 50mg, Fish oil, rich in omega-3-acids - 30mg, Alanine - 14mg, Arginine - 12mg, Proline - 11.2mg, Glycine - 11mg, Lysine acetate - 9.3mg, Leucine - 7.4mg, Serine - 6.5mg, Valine - 6.2mg, Sodium acetate, 3H2O - 5.62mg, Phenylalanine - 5.1mg, Isoleucine - 5mg, Potassium chloride - 4.48mg, Threonine - 4.4mg, Methionine - 4.3mg, Sodium glycerophosphate, anhydrous - 4.18mg, Histidine - 3mg, Magnesium sulfate, 7H2O - 2.47mg, Tryptophan - 2mg, Taurine - 1mg, Calcium chloride 2H2O - 0.74mg, Tyrosine - 0.40mg, Zinc sulfate heptahydrate - 23mcg Injectable emulsion 3,835,326 L.L
B05BA10 SMOFKABIVEN PERIPHERAL G Glucose monohydrate - 143mg, Soya-bean oil, refined - 60mg, Triglycerides, Medium Chain - 60mg, Olive oil, refined - 50mg, Fish oil, rich in omega-3-acids - 30mg, Alanine - 14mg, Arginine - 12mg, Proline - 11.2mg, Glycine - 11mg, Lysine acetate - 9.3mg, Leucine - 7.4mg, Serine - 6.5mg, Valine - 6.2mg, Sodium acetate, 3H2O - 5.62mg, Phenylalanine - 5.1mg, Isoleucine - 5mg, Potassium chloride - 4.48mg, Threonine - 4.4mg, Methionine - 4.3mg, Sodium glycerophosphate, anhydrous - 4.18mg, Histidine - 3mg, Magnesium sulfate, 7H2O - 2.47mg, Tryptophan - 2mg, Taurine - 1mg, Calcium chloride 2H2O - 0.74mg, Tyrosine - 0.40mg, Zinc sulfate heptahydrate - 23mcg Injectable emulsion 4,571,752 L.L
B05BB01 SOLUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 236,731 L.L
C09DB02 SEVIKAR B Olmesartan medoxomil - 20mg, Amlodipine - 5mg Tablet, film coated 1,019,976 L.L
C09DB02 SEVIKAR B Olmesartan medoxomil - 40mg, Amlodipine - 5mg Tablet, film coated 1,158,392 L.L
B05BB01 SERUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 216,046 L.L
C09DB02 SEVIKAR B Olmesartan medoxomil - 40mg, Amlodipine - 10mg Tablet, film coated 1,245,742 L.L
B05BB01 SERUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 232,134 L.L
B05BB01 SOLUFLEX LACTATED RINGER'S INJECTION, USP G Sodium lactate - 3.1g/l, Calcium chloride, 2H2O - 0.2g/l, Potassium chloride - 0.3g/l, Sodium chloride - 6g/l Injectable solution 264,311 L.L
N01AB07 SUPRANE (DESFLURANE, USP) B Desflurane - Inhalation 9,371,654 L.L
N01AB08 SEVOFLURANE B Sevoflurane - Inhalation 12,327,290 L.L
B05BB01 SERUFLEX RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 204,554 L.L
B05BB01 SOLUFLEX RINGER'S INJECTION, USP G Calcium chloride, 2H2O - 0.33g/l, Potassium chloride - 0.3g/l, Sodium chloride - 8.6g/l Injectable solution 221,792 L.L
J01DH51 SYNERGIC G Imipenem - 500mg, Cilastatin - 500mg Injectable powder 1,142,266 L.L
B05BB02 SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 194,211 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 188,772 L.L
B05BB02 SERUFLEX DEXTROSE 5% SODIUM CHLORIDE 0.9% INJECTION, USP G Sodium chloride - 0.9%, Glucose - 5% Injectable solution 180,421 L.L
V07AB01 STERILE WATER FOR INJECTION G Water for Injection - Water for injection, irrigation 203,481 L.L
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