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الإدارة المركزية للمستحضرات الحيوية والمبتكرة والدراسات الإكلينيكية

التقرير العلمي العام عام ٢٠٢٣-٢٠٢٤

النقرير العلمي العام 

Product Name Scientific Name Dosage Form Marketing Authorization Holder (MAH) Publish Date
​​Xenpozyme Olipudase Alfa 20 mg
Powder for concentrate for solution for infusion
Strength: 20 mg/vial
Sanofi BV.,Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands - The Netherlands 5/12/2024
Group A and C Meningococcal Polysaccharide Vaccine
Neisseria meningitidis group A capsular polysaccharide 50 mcg/0.5ml
• Neisseria meningitidis group C capsular polysaccharide 50 mcg/0.5ml
lyophilized powder for reconstitution for s.c injection Yuxi Walvax Biotechnology co. Ltd. No. 83 South Dongfeng Road, High and New Technology Industries Development Zone, Yuxi city, Yunnan Province - CHINA 28/11/2024
Omnitrope Somatropin, RH-GH 15 mg/1.5ml Solution for S.C injection in Cartiadge Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria. 26/11/2024
Mylotarg Gemtuzumab Ozogamicin 4.5 mg Powder for concentrate for solution for     infusion (powder for concentrate) Wyeth Pharmaceuticals LLC, P.O. Box 8299, Philadelphia, PA 19101, United States of America. 26/11/2024
Idacio ADALIMUMAB 40 mg Solution for injection Fresenius Kabi Deutschland GmbH, Else-Kroner StraBe 1, 61352 Bad Homburg v.d.Hohe - GERMANY 26/11/2024
Human normal immunoglobulin(IV IG) 50 or 100 mg/ml solution for IV infusion Instituto Grifols, S.A., Can Guasch, 2. Parets del Vallès, 08150 Barcelona Spain 26/11/2024
Abrysvo
RSV subgroup A stabilised prefusion F antigen 60 ug/ml;
RSV subgroup B stabilised prefusion F antigen 60 ug/ml;
Powder and Solvent for Solution for injection Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, - BELGIUM 26/11/2024
Human Albumin Human albumin Solution for infusion Instituto Grifols, S.A., Can Guash 2. Pol. Ind. Levante, 08150 Parets del Valles, Barcelona spain-SPAIN 26/11/2024
​adalimab Adalimumab 40 mg
Solution for S.C injection
Adalimumab
40 mg/0.8mL
Egyptian International Pharmaceutical
Industries Company, EIPICO, Industrial Zone
B1, Tenth of Ramadan City, Egypt
19/11/2024
​glargivin INSULIN GLARGINE 100 u/ml
Solution for injection
100 u/ml
Eva Pharma for Pharmaceutical Industries (2), Polaris Industrial District, Plot No. 27, North extensions area, 6th of October City, Giza
19/11/2024
fiasp Insulin aspart 100 U/ml
Solution for injection in prefilled Pen
Strength: 100 U/ml
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd - Denmark
19/11/2024
NABOTA Clostridium botulinum Toxin Type A- 100 unit
Powder for solution for I.M injection
Strength:100 U/2.5 ml (4 U/0.1 mL)
Daewoong pharmaceutical
Co.Ltd., 35-14, Jeyakgondan 4-gil, Hyangnam-eup, Hwaseong-si,Gyeonggi-do-Republic of Korea.
19/11/2024
Lanadelumab
Solution for injection, the solution is colorless to slightly yellow, appearing either clear or slightly opalescent. -150 mg /ml
Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50- 58 Baggot Street Lower, Dublin 2, D02 HW68 – Ireland.
14/11/2024
Hulio Adalimumab 40 mg/0.8 ml
Solution for injection Prefilled Syringe& Prefilled Pen- 40mg/0.8ml
Viatris Limited, Damastown Industrial Park mulhuddart, Dublin 15-Ireland
14/11/2024
​Alymsys Bevacizumab 25 mg/ml
Sterile, preservative-free concentrate for solution for infusion containing 25 mg/mL of bevacizumab as active substance and supplied in two presentations: MB02 100 mg/4 mL and MB02 400 mg/16 mL single-use vials.
Mabxience Research SL.C/MANUEL POMBO Angulo 28-3a y 4a planta, 28050 Madrid -Spain
14/11/2024
GC flu GCFLU Quadrivalent
Solution for IM injection in Pre-filled Syringe
GC Biopharma Corp., 40, Sandan-gil, Hwasun-eup, Hwasun-gun, Jeollanam-do. Republic of Korea
14/11/2024
Healive  Inactivated hepatitis A virus (HAV) antigen
Suspension for intramuscular injection
Sinovac Biotech Co., Ltd., No. 39 Shangdi Xi Road, Haidian District, Beijing-China
16/10/2024
Polio  OPV Sabin type I 1e+006 CCID50 ; OPV Sabin type III 630957 CCID50 ;
Oral liquid
Beijing Institute of Biological Products Co., Ltd. – Beijing Economic and Technological Development Area, Boxing 2 Road No.6, 9. - CHINA
2/10/2024
factor IX  Human Coagulation factor 50 IU/ml
Powder and solvent for solution for injection.
instituto Grifols, S.A., Can Guasch, 2. Pol. Ind . levante, 08150 Parets del Vallès, Barcelona Spain - SPAIN
2/10/2024
cecolin Human Papillomavirus Type 16L1 Protien (Recombinant) 40 mcg/0.5ml ; Human Papillomavirus Type 18L1 Protien (Recombinant) 20 mcg/0.5ml
Suspension for injection in a vial.
Xiamen Innovax Biotech Co., Ltd., No. 52, Shanbianhong East Road, Haicang District, Xiamen City, Fujian Province 361027, China
2/10/2024
Ultomiris  Ravulizumab
sterile aqueous solution for intravenous administration
Alexion Europe SAS, located at 103-105 rue Anatole France, 92300 Levallois Perret, France.
10/9/2024
Optivate 
For optivate 250 IU: Human Coagulation Factor VIII 250 I.U/2.5ml ; Von Willebrand Factor (VWF) 260 I.U./ml.
-For optivate 500 IU: Human Coagulation Factor VIII 500 I.U/5ml ; Von Willebrand Factor (VWF) 260 I.U./ml
Powder and solvent for solution of I.V. injection.
Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX - UNITED KINGDOM
1/9/2024
​Abrilada 
Adalimumab 40 mg/0.8ml
Solution for subcutaneous injection in pre-filled syringe or prefilled pen.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, - BELGIUM
1/9/2024
nexviazym
Avalglucosidase alfa 100 mg
Powder for concentrate for solution for infusion.
Sanofi BV., Paasheuvelweg 25,1105 BP Amsterdam-The Netherlands
28/8/2024
​Krabeva
Bevacizumab 25 mg/ml
Concentrate For Solution For I.V Infusion
Biocon Biologics Limited Special Economic Zone, Block No. B1, B2, B3, Q13 of Q1 and W20 and Unit S18, 1st Floor, Block B4, Plot No.: 2, 3, 4 and 5, Phase- IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengaluru, Karnataka - 560099 - India
25/8/2024
Esperoct 500 I.U & 1000
Turoctocog alfa pegol 500 I.U. and 1000 I.U
Powder and Solvent for Solution for I.V. injection
Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd- Denmark
25/8/2024
​enoxaparin USP ​
Enoxaparin sodium
Solution for subcutaneous injection
Nanjing King-Friend Biochemical Pharmaceutical Co. Ltd., No. 16 Xuefu Road, Nanjing High and New Technology Development Zone, Nanjing, Jiangsu 210061 - CHINA
25/8/2024
Bexsero
Recombinant Neisseria meningitidis group B NHBA fusion protein-Recombinant Neisseria meningitidis group B NadA protein.-Recombinant Neisseria meningitidis group B fHbp fusion protein.-Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4. 
Suspension for injection
GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena - ITALY
7/08/2024
TECAVYLI
Teclistamab 10 mg/ml
Teclistamab 90 mg/ml
Solution for injection
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse- Belgium
4/08/2024
Vabysmo
Faricimab
solution for Injection
Roche Registration GmbH, Emil-Barell-Strasse 1, Grenzach-Wyhlen, 79639 - GERMANY; 
9/7/2024
Enhertu
Trastuzumab Deruxtecan 100 mg
powder for concentrate for solution for infusion
Daiichi Sankyo Europe GmbH , Zielstattstrasse 48, 81379 Munich - GERMANY
9/7/2024
Abevmy 100 mg/4ml
Abevmy 400 mg/16m
Bevacizumab 25 mg/ml
Concentrate for solution for Infusion
Biosimilar collaborations Ireland limited unit 35/36 Grange parade, baldoyle industrial estate, Dublin 13, Ireland D13 R20R.
9/7/2024
Skyrizi 150mg

Risankizumab

150 mg

Solution for injection
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany.
18/3/2024
Shingrix vaccine Varicella Zoster Virus glycoprotein E antigen 50 mcg/0.5ml

Powder and suspension 

for suspension for injection

GlaxoSmithKline Biologicals SA 89, rue de l"Institut, B-1330 Rixensart - BELGIUM
18/3/2024
Sarclisa 100&500 MG

Isatuximab100 mg/5ml

Isatuximab 500 mg/25m

Concentrate for solution for Infusion
Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentillty - France
18/3/2024
Pelgraz
Pegfilgrastim 6mg/0.6ml Solution
Solution for injection
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF - United Kingdom
18/3/2024
MenQuadfi
Meningococcal group A, C, W135, Y conjugated to Tetanus Toxoid
Solution for injection
Sanofi Pasteur Inc., 1 Discovery Drive, Swiftwater, PA 18370 - USA
18/3/2024
Herzuma
Trastuzumab150mg
Lypholized Powder and solvent for solution for injection
Celltrion, Inc., 20 Academy-ro 51 beon-gil, Yeonsu-gu Incheon, Republic of Korea.
18/3/2024
Afstyla
 single chain coagulation factor VIII (rVIII-single chain
Powder and solvent for solution for injection
CSL Behring GmbH Emil-von-Behring-Straβe 76, D-35041 Marburg-Germany
18/3/2024

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