New chemical Entity Registered ( )

N# Product Name Registration Date )ل ف ) 1 Dosage form Strength Active Ingredient Drug Store 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 19/7/2005 Avastin Vial 100 Bevacizumab Drug Store roche 4 Aranesp 18/8/2005 PFS 100mcg Darbepoetin alfa Adatco Aen 5 Abilify 15 19/9/2005 tab 15 Aripiprazole Orient Drug Store Bristol Myers 6 Norprolac 75mcg 19/9/2005 tab 75mcg Quinagolide Petra drug store Ferring GmbH 7 27/11/2005 Lab 3 M Aldara 5% cream 5% imiquimod Khraim drug Store Santé/France 8 23/11/2005 Gemifloxacin Factive tab 320 mesylate Hikma Hikma 9 15/12/2005 Solifenacin Vesicare tab 10 succinate Ibn rushd Yamanoushi 10 Mycamine 10/5/2005 Vial 50 Micafungin sodium Hikma Hikma 11 3/1/2006 Eye drops Relestat 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 Drug Store Les lab servier 14 Certican 19 /2/ 2006 tab 1 Everolimus Jordan Drug Store Novartis pharma 15 Xoliar 21/3/2006 Inj Omalizumab Jordan Drug Store Novartis pharma 16 Lyrica 5 /4/ 2006 cap 25 Pregabalin Alsabbagh Pfizer 17 9 /5/ 2006 Powder for conc Alimta for sol for infusion 25/ml Pemetrexed Arab Drug store Eli Lilly 18 30 /5/ 2006 Sol for inj in Apidra vial 100IU/ml Insulin glulisine Ulfa Aventis Pharma

19 Levemir penfill 5 /6/ 2006 Sol for inj 100IU/ml Insulin detemir Khoury NovoNnordisk 20 Exjade 20 /6/ 2006 Dispersible tab 250 deferasirox Jordan Drug Store Novartis pharma 21 31 /7/ 2006 Methylphenidate ncerta tab 36 HCl Ninos Janssen cilag 22 30 /8/ 2006 nc for sol for Mabcampath infusion 30/ml Alemtuzumab Jordan drug store Schering AG 23 19/12/2006 nc for sol for Aldurazyme infusion 100IU/ml laronidase الزراعية Genzyme 24 14 /1/ 2007 Duloxetine Hcl 60 Eli Lilly Export Cymbalta CAP 60 The Arab Drug Store S.A 25 16 /1/ 2007 Oxcarbazepine 60 Trileptal tab 300 /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 15 /7/ 2007 Les Laboratories Procoralan TAB 5 Ivabradine 5 Servier 30 12 /8/ 2007 Carbetocin 100 Pabal INJE 100 ug/ml ug/ml Petra Drug Store Ferring GmbH 31 23 /9/ 2007 0.50%,40 Timolol 0.50 %, Duotrav EAR Drop ug Travaprost 40 Modern Drug Store Alcon-uvreur 32 2 /10/ 2007 Ranibizumab 10 Lucentis SOLU 10 /ml /ml 33 Champix 0.5 11/10/ 2007 TAB 0.5 Varenicline 0.5 Sabbagh Drug Store Pfizer 34 18/11/ 2007 Telbivudine 600 Sebivo TAB 600 35 10 /2/ 2008 Loteprednol Bausch & Lomb Lotemax SUSP 0.5 % Etabonate 0.5 % Petra Drug Store Incorporated

36 28 /2/ 2008 Cladribine 10 Litak VIAL 10 /5ml /5ml Al Wafi Drug Store Lipomed AG 37 23 /3/ 2008 Meropenem Meronem 1gm inj 1 gm Trihydrate 1 gm Drug Store AstraZeneca 38 Invega Extended Release 9 /4/ 2008 TAB 6 Paliperidone 6 Telegraph Drug Store Janssen Cilag 39 20 /4/ 2008 ORIENT DRUG Bristol Myers Sprycel 20 TAB 20 Dasatinib 20 STORE CO Squibb 40 27 /4/ 2008 Mitiglinide Glufast TAB 5 Calcium Hydrate5 Hikma Pharmaceuticals Hikma Pharmaceuticals 41 20 /5/ 2008 Suleiman Tannous & Relenza tab 5 Zanamivir 5 Sons. Ltd GSK 42 22 /5/ 2008 Levobupicacaine Walid Al Turk Drug Chirocaine Amp Amp 2.5 /ml Hcl 2.5/ml Store Abbott 43 27 /7/ 2008 Memantine Hcl 10 Abu Sharef Medical H-Lundbeck A/S Ebixa TAB 10 Stors overseas 44 4 /8/ 2008 300/15m Natalizumab 300 Tysabri SOLU l /15ml Adatco Drug Store Elan Pharma 45 27 /8/ 2008 Adefovir Dipivoxil Suleiman Tannous & Hepsera TAB 10 10 Sons. Ltd GlaxoWellcome 46 2 /9/ 2008 Sorafenib Tosyllate Nexavar TAB 200 200 Khoury Drug Store Bayer AG 47 22 /11/ 2008 Gadoversetamide 330.9 330.9 g/ml Optimark 0.5mmol/ml(20ml) INJE /ml Sabbagh Drug Store Mallinckrodt 48 24 /11/ 2008 49 Tasigna Cubicin 14 /12/ 2008 CAPS 200 Nilotinib 200 Daptomycin 350 Powder 350 Roche Pharma novartis

50 24 /12/ 2008 Rasilez tab TAB 300 Aliskiren 300 novartis 51 Januvia 31 /12/ 2008 TAB 100 Sitagliptin 100 Adatco Drug Store Merck &.Inc 52 12 /1/ 2009 Valganciclovir 450 F.Hoffmann La- Valcyte F.C.Tablet TAB 450 Drug Store Roche 53 8 /4/ 2009 Tarceva F.C.Tablet TAB 100 Erlotinib 100 Drug Store roche 54 5 /5/ 2009 Suleiman Tannous & Tykerb TAB 250 Lapatinib 250 Sons. Ltd Glaxo Group Ltd 55 7 /12/ 2009 Rivaroxaban Xarelto TAB 10 Micronized 10 Khoury Drug Store Bayer Health Care 56 Firmagon vial 20/6/2010 Powder& solvent for Degarelix solution for inj 80 Petra drug store Ferring 28/11/2010 Sugammadex 57 Bridion injection 100/ml Adatco N.V Organon 10/2/2011 Jordan Drug Store 58 Valdoxan Agomelatine. tab 25 Servier 59 13/11/2011 capsules Jordan Drug Store Onbrez Breezhaler containing a powder for 150 and 300 Indacaterol maleate Novartis inhalation micrograms 60 Victoza 28/11/2011 inj in PFP 6 /ml Liraglutide Khoury Drug Store Novo Nordisk

61 62 Multaq F.C tab IBD: 31/7/2009 Submission date:14/10/2010 Prolia. IBD: 26/5/2010 Submission date:16/12/2010 63 Onglyza IBD: 31/7/2009 Submission date:27/1/2011 19/6/2012 4/3/2012 F.C tab inj in PFP 400 60/ml 17/5/2012 Tab 5 Dronedarone Denosumab Saxagliptin Ulfa Drug Store Adatco drug store Drug Store Sanofi Aventis Aen Astrazeneca Gilenya 64 IBD: 17/8/2010 Submission date:28/4/2011 65 Brilinta IBD: 3/12/2010 Submission date:12/5/2011 Jevtana vial 66 IBD: 17/8/2010 Submission date:28/4/2011 67 Zytiga IBD: 28/4/2011 Submission date:26/1/2012 68 Brinavess IBD: 9/2010 Submission date:27/10/2011 15/4/2012 11/7/2012 22/1/2013 10/11/2013 14/3/2013 Cap 0.5 Fingolimod Drug Store Tab 90 Ticagrelor Novartis Astrazeneca conc. & solvent for infusion. 60 Cabazitaxel Ulfa Drug Store Sanofi Tablet 250 Abitraterone Acetate Telegraph Drug Store Janssen-Cilag Inernational ncentrate for infusion 20/ml Vernakalant Hcl Adatco drug store MSD LTD

69 Trajenta IBD: 20/5/2011 Submission date: 6/11/2012 70 Incivo IBD: 23/5/2011 Submission date:13/3/2012 71 Victrelis IBD : 13/5/2011 Submission date : 19/2/2012 72 Stivarga IBD : 27/9/2012 Submission date : 14/8/2013 2/4/2014 73 Eylea IBD : 18/11/2011 Submission date : 4/4/2013 21/5/2014 74 Signifor IBD : 24/4/2012 Submission date : 20/5/2013 5/11/2014 9/10/2013 21/10/2013 21/7/2013 20/5/2014 6/7/2014 8/2/2015 tablet 5 Linagliptin Arab drug store (shqer) tablet 375 Telaprevir Ninos drug store Hard capsule 200 Boceprevir Adatco drug store tablet 40 Regorafinib Khori drug store injection 40 /ml aflibercept Khori drug store injection 0.3 /ml 0.6 /ml 0.9/ml Pasireotide Dispartate Boehringer Ingelheim International GmbH,Ingelheim am Rhein Janssen-Cilag international MSD/Ltd UK Bayer Pharma A G / Germany Bayer Pharma A G / Germany /Switzerland

75 Zelboraf IBD : 17/8/2011 Submission date : 14/10/2012 19/11/2014 76 Lyxumia IBD : 7/1/2013 Submission Date : 28/11/2013 5/8/2015 77 Exviera IBD : 15/1/2015 Submission Date : 10/2/2015 12/8/2015 78 Viekirax IBD : 15/1/2015 Submission Date : 10/2/2015 19/8/2015 97 Giotrif IBD : 2/7/2013 Submission Date : 29/9/2014 16/9/2015 4/2/2015 9/12/2015 30/8/2015 30/9/2015 26/11/2015 tablet 240 Vemurafenib Pre-filled Pen Drug Store 10mcg 20mcg 10&20 mcg Lixisenatide Ulfa Drug Store Tablet 250 Dasabuvir Tablet 12.5 75 50 Ombitasvir Paritaprevir Ritonavir tablet 20 Afatinib Abu sheikha drug store Abu sheikha drug store Arab drug store (shqer) F.hoffman la-roche /Switzerland Sanofi avemtis groupe/ France Abbvie limited / UK Abbvie limited / UK Boehringer ingelheim international / Germany

08 Entresto IBD : 7/7/2015 Submission Date : 7/7/2015 6/1/2016 08 Keytruda IBD : 4/9/2014 Submission Date : 1/7/2015 29/6/2016 08 Repatha IBD 17/7/2015 Submission Date : 6/12/2015 27/7/2016 83 Harvoni IBD : 10/10/2014 Submission Date : 28/10/2015 20/7/2016 84 Opdivo IBD : 4/7/2014 Submission Date : 22/10/2015 20/7/2016 27/1/2016 3/8/2016 30/8/2016 21/8/2016 2/11/2016 tablet 50 100 200 Sacubitril/Valsartan infusion 100/4ml Pembrolizumab Adatco drug store injection 140/ml Evolocumab Adatco drug store tablet 90 400 Ledipasvir Sofosbuvir Beta drug store /Switzerland MSD/Ltd USA Aen Europe /Netherlands Gilead Sciences International LTD/ UK infusion 40/4ml Nivolumab Orient drug store Bristol Mayers Squibb NJ /USA

85 sentyx IBD : 26/12/2014 Submission Date : 13/4/2015 23/11/2016 18/12/2016 injection 150/ml Secukinumab AG-Basel /Switzerland Last reviewed in 22/01/2017. في حال الحاجة لالعتراض على محتويات القائمة ارجو ارسال كتاب رسمي لقسم التسجيل.