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1 N# Product Name Registration Date )ل ف ) 1 Dosage form Strength Active Ingredient Marketing Authorization Holder 1 pegus 25/5/2005 tab 200 Ribavarin Shawi Roche 2 Velcade 7/7/2005 vial 3.5 bortezomib mina Janssen cilag 3 Avastin 19/7/2005 Vial 100 Bevacizumab roche 4 Aranesp 18/8/2005 PFS 100mcg Darbepoetin alfa Adatco Aen 5 Abilify 15 19/9/2005 tab 15 Aripiprazole Orient Bristol Myers 6 Norprolac 75mcg 19/9/2005 tab 75mcg Quinagolide Petra drug store Ferring GmbH 7 Aldara 5% 27/11/2005 cream 5% imiquimod Khraim drug Store Lab 3 M Santé/France 8 Factive 23/11/2005 tab 320 Gemifloxacin mesylate Hikma Hikma 9 Vesicare 15/12/2005 tab 10 Solifenacin succinate Ibn rushd Yamanoushi 10 Mycamine 10/5/2005 Vial 50 Micafungin sodium Hikma Hikma 11 Relestat 3/1/2006 Eye drops solution 0.05% Epinastine Arab & Agricultura Allergen 12 Strattera 5 /2/ 2006 cap Atomoxetine Arab Drug store Eli Lilly 13 Protelos 12 /2/ 2006 powder 2gm Strontium Ranelate Jordan Les lab servier 14 Certican 19 /2/ 2006 tab 1 Everolimus Jordan Novartis pharma 15 Xoliar 21/3/2006 Inj Omalizumab Jordan Novartis pharma 16 Lyrica 5 /4/ 2006 cap 25 Pregabalin Alsabbagh Pfizer 17 Alimta 9 /5/ 2006 Powder for conc for sol for 25/ml Pemetrexed Arab Drug store Eli Lilly 18 Apidra 30 /5/ 2006 Sol for inj in vial 100IU/ml Insulin glulisine Ulfa Aventis Pharma 19 Levemir penfill 5 /6/ 2006 Sol for inj 100IU/ml Insulin detemir Khoury NovoNnordisk

2 20 Exjade 20 /6/ 2006 Dispersible tab 250 deferasirox Jordan Novartis pharma 21 ncerta 31 /7/ 2006 tab 36 Methylphenidate HCl Ninos Janssen cilag 22 Mabcampath 30 /8/ 2006 nc for sol for 30/ml Alemtuzumab Jordan drug store Schering AG 23 Aldurazyme 19/12/2006 nc for sol for 100IU/ml laronidase الزراعية Genzyme 24 Cymbalta 14 /1/ 2007 CAP 60 Duloxetine Hcl 60 Eli Lilly Export The Arab S.A 25 Trileptal 16 /1/ 2007 tab 300 Oxcarbazepine 60 /ml 26 Baraclude tab 18 /1/ 2007 tab 1 Entecavir Orient 27 Meiact tab 14 /2/ 2007 Tab 200 Cefditoren Sukhtian Tabuk 28 Zymar 28 /3/ 2007 Opth. solu 0.3% Gatifloxacin الزراعية Allergen 29 Procoralan 15 /7/ 2007 TAB 5 Ivabradine 5 Les Laboratories Servier Carbetocin Pabal 12 /8/ 2007 INJE 100 ug/ml Petra Ferring GmbH ug/ml 0.50%,40 Timolol 0.50 %, 31 Duotrav 23 /9/ 2007 EAR Drop Modern Alcon-uvreur ug Travaprost 40 Ranibizumab Lucentis 2 /10/ 2007 SOLU 10 /ml /ml 33 Champix /10/ 2007 TAB 0.5 Varenicline 0.5 Sabbagh Pfizer Telbivudine Sebivo 18/11/ 2007 TAB 600 Loteprednol Bausch & Lomb 35 Lotemax 10 /2/ 2008 SUSP 0.5 % Petra Etabonate 0.5 % Incorporated Cladribine Litak 28 /2/ 2008 VIAL 10 /5ml Al Wafi Lipomed AG /5ml

3 Meropenem 37 Meronem 1gm 23 /3/ 2008 inj 1 gm AstraZeneca Trihydrate 1 gm 38 Invega Extended Release 9 /4/ 2008 TAB 6 Paliperidone 6 Telegraph Janssen Cilag ORIENT DRUG Bristol Myers 39 Sprycel /4/ 2008 TAB 20 Dasatinib 20 STORE CO Squibb 40 Glufast 27 /4/ 2008 TAB 5 Mitiglinide Calcium Hydrate5 41 Relenza 20 /5/ 2008 tab 5 Zanamivir 5 42 Chirocaine Amp 22 /5/ 2008 Amp 2.5 /ml 43 Ebixa 27 /7/ 2008 TAB Tysabri 4 /8/ 2008 SOLU 300/15m l 45 Hepsera 27 /8/ 2008 TAB Nexavar 2 /9/ 2008 TAB Optimark 0.5mmol/ml(20ml) 22 /11/ 2008 INJE /ml Hikma Pharmaceuticals Suleiman Tannous & Sons. Ltd Walid Al Turk Drug Store Abu Sharef Medical Stors Hikma Pharmaceuticals GSK Levobupicacaine Hcl 2.5/ml Abbott Memantine Hcl 10 H-Lundbeck A/S overseas Natalizumab 300 /15ml Adatco Elan Pharma Adefovir Dipivoxil Suleiman Tannous & 10 Sons. Ltd GlaxoWellcome Sorafenib Tosyllate 200 Khoury Bayer AG Gadoversetamide g/ml Sabbagh Mallinckrodt 48 Tasigna 24 /11/ 2008 CAPS 200 Nilotinib 200 Roche Pharma 49 Cubicin 14 /12/ 2008 Powder 350 Daptomycin 350 novartis 50 Rasilez tab 24 /12/ 2008 TAB 300 Aliskiren 300 novartis 51 Januvia 31 /12/ 2008 TAB 100 Sitagliptin 100 Adatco Merck &.Inc

4 52 Valcyte F.C.Tablet 12 /1/ 2009 TAB 450 Valganciclovir Tarceva F.C.Tablet 8 /4/ 2009 TAB 100 Erlotinib Tykerb 5 /5/ 2009 TAB 250 Lapatinib Xarelto 7 /12/ 2009 TAB Firmagon vial 20/6/2010 Bridion 28/11/2010 Valdoxan Powder& solvent for solution for inj /ml Rivaroxaban Micronized 10 Degarelix Sugammadex Suleiman Tannous & Sons. Ltd Khoury Petra drug store Adatco F.Hoffmann La- Roche roche Glaxo Group Ltd Bayer Health Care Ferring N.V Organon 10/2/2011 tab 25 Agomelatine. Jordan Servier Onbrez Breezhaler Victoza 13/11/ /11/2011 capsules containing a powder for inhalation inj in PFP 150 and 300 micrograms 6 /ml Indacaterol maleate Liraglutide Jordan Khoury Novartis Novo Nordisk 61 Multaq F.C tab IBD: 31/7/2009 Submission date:14/10/ /6/2012 F.C tab 400 Dronedarone Ulfa Sanofi Aventis

5 62 Prolia. IBD: 26/5/2010 Submission date:16/12/2010 4/3/2012 inj in PFP 60/ml Denosumab Adatco drug store Aen 63 Onglyza IBD: 31/7/2009 Submission date:27/1/ /5/2012 Tab 5 Saxagliptin Astrazeneca Gilenya IBD: 17/8/2010 Submission date:28/4/2011 Brilinta IBD: 3/12/2010 Submission date:12/5/2011 Jevtana vial IBD: 17/8/2010 Submission date:28/4/2011 Zytiga IBD: 28/4/2011 Submission date:26/1/2012 Brinavess IBD: 9/2010 Submission date:27/10/2011 Trajenta IBD: 20/5/2011 Submission date: 6/11/2012 Incivo IBD: 23/5/2011 Submission date:13/3/ /4/ /7/ /1/2013 Cap 0.5 Fingolimod Tab 90 Ticagrelor conc. & solvent for. 10/11/2013 Tablet /3/2013 9/10/ /10/2013 ncentrate for Novartis Astrazeneca 60 Cabazitaxel Ulfa Sanofi Abitraterone Acetate Telegraph Janssen-Cilag Inernational 20/ml Vernakalant Hcl Adatco drug store MSD LTD 5 Linagliptin Arab drug store (shqer) 375 Telaprevir Ninos drug store Boehringer Ingelheim International GmbH,Ingelheim am Rhein Janssen-Cilag international

6 Victrelis IBD : 13/5/2011 Submission date : 19/2/2012 Stivarga IBD : 27/9/2012 Submission date : 14/8/2013 2/4/2014 Eylea IBD : 18/11/2011 Submission date : 4/4/ /5/2014 Signifor IBD : 24/4/2012 Submission date : 20/5/2013 5/11/ /7/2013 Hard capsule 200 Boceprevir Adatco drug store 20/5/2014 6/7/2014 8/2/ Regorafinib Khori drug store 40 /ml aflibercept Khori drug store 0.3 /ml 0.6 /ml 0.9/ml Pasireotide Dispartate MSD/Ltd UK Bayer Pharma A G / Germany Bayer Pharma A G / Germany /Switzerland Zelboraf IBD : 17/8/2011 Submission date : 14/10/ /11/2014 Lyxumia IBD : 7/1/2013 4/2/2015 9/12/2015 Pre-filled Pen mcg 20mcg Vemurafenib Lixisenatide Ulfa F.hoffman la-roche /Switzerland Sanofi avemtis groupe/ France

7 Submission Date : 28/11/2013 5/8/2015 Exviera IBD : 15/1/2015 Submission Date : 10/2/ /8/2015 Viekirax IBD : 15/1/2015 Submission Date : 10/2/ /8/2015 Giotrif IBD : 2/7/2013 Submission Date : 29/9/ /9/ &20 mcg 30/8/2015 Tablet 250 Dasabuvir 30/9/2015 Tablet 26/11/ Ombitasvir Paritaprevir Ritonavir 20 Afatinib Abu sheikha drug store Abu sheikha drug store Arab drug store (shqer) Abbvie limited / UK Abbvie limited / UK Boehringer ingelheim international / Germany Entresto IBD : 7/7/2015 Submission Date : 7/7/2015 6/1/2016 Keytruda IBD : 4/9/2014 Submission Date : 1/7/ /1/2016 3/8/ Sacubitril/Valsartan 100/4ml Pembrolizumab Adatco drug store /Switzerland MSD/Ltd USA

8 29/6/ Repatha IBD 17/7/2015 Submission Date : 6/12/ /7/2016 Harvoni IBD : 10/10/2014 Submission Date : 28/10/ /7/2016 Opdivo IBD : 4/7/2014 Submission Date : 22/10/ /7/ /8/ /8/2016 2/11/ /ml Evolocumab Adatco drug store Ledipasvir Sofosbuvir Beta drug store 40/4ml Nivolumab Orient drug store Aen Europe /Netherlands Gilead Sciences International LTD/ UK Bristol Mayers Squibb NJ /USA sentyx IBD : 26/12/2014 Submission Date : 13/4/ /11/2016 Daklinza IBD : 4/7/2014 Submission Date : 30/3/ /9/ /12/ /11/ /ml Secukinumab 60 Daclatasvir Orient drug store AG-Basel /Switzerland Bristol Myers Squibb /UK

9 Jardiance IBD : 17/4/2014 Submission Date :20/9/2015 mmission decision date: 8/2/ /3/2017 Tablet Empagliflozin Arab drug store (shqer) Boehringer ingelheim international /Germany Blincyto IBD : 3/12/2014 Submission Date : 5/10/ /3/ /4/2017 Lyophilized powder in a single-use vial for reconstitution 35 mcg Binatumomab Adatco drug store Aen Inc/USA Ibrance IBD : 3/2/2015 Submission Date :19/5/ /5/ /7/2017 Capsule Palbociclib Sabagh drug store Pfizer Inc/USA Last reviewed in 12/11/2017. في حال الحاجة لالعتراض على محتويات القائمة ارجو ارسال كتاب رسمي لقسم التسجيل.

New chemical Entity Registered ( )

New chemical Entity Registered ( ) N# Product Name Registration Date )ل ف ) 1 Dosage form Strength Active Ingredient Marketing Authorization Holder 1 pegus 25/5/2005 tab 200 Ribavarin Shawi Roche 2 Velcade 7/7/2005 vial 3.5 bortezomib mina

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