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List of Registered Implantable Medical Devices at MOPH


The Ministry of Health (MoPH), in cooperation with the “Agence Française de sécurité du médicament et des produits de santé (Ansm)” is implementing aregulatory system for the importation and use of medical devices; this project is conducted in a context where the health authorities give priority to the optimum use of resources, market assessment and the exercise of a post-marketing surveillance that will respond to any sanitary measures according to the latest international guidelines.

Based on the Decision No.455/1 Dated 16/04/2013, rules and procedures have been established for:
 
  • The import of medical devices in Lebanon including the qualification of suppliers.
  • The registration of medical devices in the MoPH.
  • The post-market surveillance of medical devices placed on the market.
The procedure sets the requirements and conditions for the import and registration of medical devices as well as the qualifications of suppliers.

In summary,

A medical device supplier must declare beforehand to the Ministry of Public Health.

Before its first commissioning, all implantable medical devices must be registered on the National List of Implantable Medical Devices to MoPH using a harmonized coding systemat national level.

Suppliers and users (public and private hospitals) must keep records to monitor post-marketing and traceability of medical devices placed on the market.
 
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ATC Name B/G Ingredients Dosage Form Price
L01FE02 VECTIBIX BioTech Panitumumab - 100mg/5ml 100mg/5ml Injectable concentrated solution L.L
B02BX04 NPLATE BioTech Romiplostim - 250mcg 250mcg Injectable powder for solution L.L
L01FD02 PERJETA 420MG BioTech Pertuzumab - 420mg/14ml 420mg/14ml Injectable concentrate for solution L.L
J07BC02 HEALIVE-HEPATITIS A VACCINE (HUMAN DIPLOID CELL) INACTIVATED BioTech Hepatitis A, inactivated antigen (TZ84 Strain), human diploid cell - 0.5ml/dose 0.5ml/dose Injectable suspension 1,777,904 L.L
L01FD03 KADCYLA BioTech Trastuzumab emtansine - 100mg 100mg Injectable powder for concentrate for solution L.L
J07BC02 HEALIVE-HEPATITIS A VACCINE (HUMAN DIPLOID CELL) INACTIVATED BioTech Hepatitis A, inactivated antigen (TZ84 Strain), human diploid cell - 1ml/dose 0.5ml/dose Injectable suspension 2,257,655 L.L
L04AA23 TYSABRI BioTech Natalizumab - 300mg/15ml 300mg/15ml Injectable concentrated solution 126,830,594 L.L
L01FD03 KADCYLA BioTech Trastuzumab emtansine - 160mg 160mg Injectable powder for concentrate for solution L.L
L01FX04 YERVOY BioTech Ipilimumab - 50mg/10ml 50mg/10ml Injectable solution L.L
L01FX05 ADCETRIS BioTech Brentuximab Vedotin - 50mg 50mg Injectable powder for concentrate for solution L.L
L01FA03 GAZYVA BioTech Obinutuzumab - 1000mg/40ml 1000mg/40ml Injectable concentrate for solution L.L
L01FF02 KEYTRUDA BioTech Pembrolizumab - 100mg/4ml 100mg/4ml Injectable solution L.L
A10BJ02 SAXENDA BioTech Liraglutide - 6mg/ml 6mg/ml Injectable solution 16,747,035 L.L
J07BG01 RABIVAX-S (RABIES VACCINE INACTIVATED) BioTech Freeze dried inactivated purified rabies antigen (Pitman Moore PM3218 as virus strain) - Injectable freeze dried material 1,552,138 L.L
A16AB07 MYOZYME BioTech Alglucosidase alfa, recombinant human acid - 50mg 50mg Injectable powder for concentrate for solution L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 0.75mg/0.5ml 0.75mg/0.5ml Injectable solution 10,165,201 L.L
L01FF01 OPDIVO BioTech Nivolumab - 100mg/10ml 100mg/10ml Injectable solution L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 1.5mg/0.5ml 1.5mg/0.5ml Injectable solution 10,165,201 L.L
L01FF01 OPDIVO BioTech Nivolumab - 40mg/4ml 40mg/4ml Injectable solution L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 3mg/0.5ml 3mg/0.5ml Injectable solution 10,165,201 L.L
J07BH01 ROTASIIL, ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL FREEZE-DRIED) BioTech Rotavirus bovine-human , live attenuated - Suspension 2,822,069 L.L
L01FG02 CYRAMZA BioTech Ramucirumab - 500mg/50ml 500mg/50ml Injectable solution L.L
A10BJ05 TRULICITY BioTech Dulaglutide - 4.5mg 4.5mg/0.5ml Injectable solution 10,165,201 L.L
J07BH01 ROTASIIL, ROTAVIRUS VACCINE, LIVE ATTENUATED (ORAL LIQUID) BioTech Rotavirus bovine-human , live attenuated - Liquid 2,822,069 L.L
L04AC05 STELARA BioTech Ustekinumab - 90mg 90mg Injectable solution L.L
J07BK01 VARICELLA VACCINE LIVE BioTech Varicella-herpes zoster virus (Oka strain), grown in human diploid cells (SV-cell line), live attenuated - Injectable suspension 3,104,276 L.L
B02BD02 XYNTHA BioTech Moroctocog alfa - 500IU 500IU Injectable lyophilised powder for solution+diluent L.L
L01FC01 DARZALEX BioTech Daratumumab - 400mg/20ml 400mg/20ml Injectable concentrate for solution L.L
L04AA33 ENTYVIO BioTech Vedolizumab - 300mg 300mg Injectable powder for concentrate for solution 152,492,033 L.L
J07CA09 HEXAXIM BioTech Diphteria Toxoid - ?20IU/0.5ml, Tetanus toxoid - ?40IU/0.5ml, Bordetella Pertussis Antigens: toxoid - 25mcg/0.5ml, Bordetella Pertussis Antigens: filamentous haemagglutinin - 25mcg/0.5ml, Polio virus inactivated type 1 (Mahoney strain) - 40D antigen units/0.5ml, Polio virus inactivated type 2 (MEF-I strain) - 8D antigen units/0.5ml, Polio virus inactivated type 3 (Saukett strain) - 32D antigen units/0.5ml, Hepatitis B, surface antigen - 10mcg/0.5ml, H. Influenza type b polysaccharide1 ,2 - 12mcg/0.5ml, 1 conjugated to tetanus protein - 22-36mcg, 2 adsorbed on aluminium hydroxide hydrated, Al+++ - 0.6mg Injectable suspension 4,462,901 L.L
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