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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 19/7/2005 Avastin 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 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 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 9 /5/ 2006 Powder for conc Alimta for sol for infusion 25/ml Pemetrexed Arab Drug store Eli Lilly /5/ 2006 Sol for inj in Apidra vial 100IU/ml Insulin glulisine Ulfa Aventis Pharma

2 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 Novartis pharma /7/ 2006 Methylphenidate ncerta tab 36 HCl Ninos Janssen cilag /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 /1/ 2007 Duloxetine Hcl 60 Eli Lilly Export Cymbalta CAP 60 The Arab S.A /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 /7/ 2007 Les Laboratories Procoralan TAB 5 Ivabradine 5 Servier /8/ 2007 Carbetocin 100 Pabal INJE 100 ug/ml ug/ml Petra Ferring GmbH /9/ %,40 Timolol 0.50 %, Duotrav EAR Drop ug Travaprost 40 Modern Alcon-uvreur 32 2 /10/ 2007 Ranibizumab 10 Lucentis SOLU 10 /ml /ml 33 Champix /10/ 2007 TAB 0.5 Varenicline 0.5 Sabbagh Pfizer 34 18/11/ 2007 Telbivudine 600 Sebivo TAB /2/ 2008 Loteprednol Bausch & Lomb Lotemax SUSP 0.5 % Etabonate 0.5 % Petra Incorporated

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

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

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

6 69 Trajenta IBD: 20/5/2011 Submission date: 6/11/ Incivo IBD: 23/5/2011 Submission date:13/3/ Victrelis IBD : 13/5/2011 Submission date : 19/2/ Stivarga IBD : 27/9/2012 Submission date : 14/8/2013 mmission decision date : 2/4/ Eylea IBD : 18/11/2011 Submission date : 4/4/2013 mmission decision date : 21/5/ Signifor IBD : 24/4/2012 Submission date : 20/5/2013 mmission decision date : 5/11/2014 9/10/ /10/ /7/ /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 Solution for injection 40 /ml aflibercept Khori drug store Solution for 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

7 75 Zelboraf IBD : 17/8/2011 Submission date : 14/10/2012 mmission decision date : 19/11/ Lyxumia IBD : 7/1/2013 Submission Date : 28/11/2013 mmission decision date : 5/8/ Exviera IBD : 15/1/2015 Submission Date : 10/2/2015 mmission decision date : 12/8/ Viekirax IBD : 15/1/2015 Submission Date : 10/2/2015 mmission decision date : 19/8/ Giotrif IBD : 2/7/2013 Submission Date : 29/9/2014 mmission decision date : 16/9/2015 4/2/2015 9/12/ /8/ /9/ /11/2015 tablet 240 Vemurafenib Pre-filled Pen 10mcg 20mcg 10&20 mcg Lixisenatide Ulfa Tablet 250 Dasabuvir Tablet 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 Last reviewed in 12/12015 في حال الحاجة لالعتراض على محتويات القائمة ارجو ارسال كتاب رسمي لقسم التسجيل.