الإدارة المركزية للمستحضرات الحيوية والمبتكرة والدراسات الإكلينيكية
| Publish Date |
Marketing Authorization Holder (MAH) |
Dosage Form | Scientific Name | Product Name | # |
| 14/12/2023 | Solution for injection in prefilled syringe for subcutaneous administration |
Teriparatide (r-PTH 1-34) | Bonosome r-DNA | 1 | |
| 18/3/2024 | CSL Behring GmbH Emil-von-Behring-Straβe 76, D-35041 Marburg-Germany | Powder and solvent for solution for injection | single chain coagulation factor VIII (rVIII-single chain | Afstyla | 2 |
| 18/3/2024 | Celltrion, Inc., 20 Academy-ro 51 beon-gil, Yeonsu-gu Incheon, Republic of Korea. | Lypholized Powder and solvent for solution for injection | Trastuzumab150mg | Herzuma | 3 |
| 18/3/2024 |
Sanofi Pasteur Inc., 1 Discovery Drive, Swiftwater, PA 18370 - USA |
Solution for injection |
Meningococcal group A, C, W135, Y conjugated to Tetanus Toxoid |
MenQuadfi | 4 |
| 18/3/2024 |
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF - United Kingdom |
Solution for injection |
Pegfilgrastim 6mg/0.6ml Solution |
Pelgraz | 5 |
| 18/3/2024 |
Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentillty - France |
Concentrate for solution for Infusion |
Isatuximab100 mg/5ml Isatuximab 500 mg/25m |
Sarclisa 100&500 MG | 6 |
| 18/3/2024 |
GlaxoSmithKline Biologicals SA 89, rue de l"Institut, B-1330 Rixensart - BELGIUM |
Powder and suspension for suspension for injection |
Varicella Zoster Virus glycoprotein E antigen 50 mcg/0.5ml |
Shingrix vaccine | 7 |
| 18/3/2024 |
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany. |
Solution for injection |
Risankizumab 150 mg |
Skyrizi 150mg | 8 |
| 9/7/2024 |
Biosimilar collaborations Ireland limited unit 35/36 Grange parade, baldoyle industrial estate, Dublin 13, Ireland D13 R20R. |
Concentrate for solution for Infusion |
Bevacizumab 25 mg/ml |
Abevmy 100 mg/4ml Abevmy 400 mg/16m |
9 |
| 9/7/2024 |
Daiichi Sankyo Europe GmbH , Zielstattstrasse 48, 81379 Munich - GERMANY |
powder for concentrate for solution for infusion |
Trastuzumab Deruxtecan 100 mg |
Enhertu | 10 |
| 9/7/2024 |
Roche Registration GmbH, Emil-Barell-Strasse 1, Grenzach-Wyhlen, 79639 - GERMANY; |
solution for Injection |
Faricimab |
Vabysmo | 12 |
| 4/08/2024 |
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse- Belgium |
Solution for injection |
Teclistamab 10 mg/ml
Teclistamab 90 mg/ml
|
TECAVYLI | 13 |
| 7/08/2024 |
GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena - ITALY |
Suspension for injection | 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. | Bexsero | 14 |
| 25/8/2024 |
Nanjing King-Friend Biochemical Pharmaceutical Co. Ltd., No. 16 Xuefu Road, Nanjing High and New Technology Development Zone, Nanjing, Jiangsu 210061 - CHINA |
Solution for subcutaneous injection | Enoxaparin sodium | 15 | |
| 25/8/2024 |
Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd- Denmark |
Powder and Solvent for Solution for I.V. injection | Turoctocog alfa pegol 500 I.U. and 1000 I.U | 16 | |
| 25/8/2024 |
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 |
Concentrate For Solution For I.V Infusion | Bevacizumab 25 mg/ml | 17 | |
| 28/8/2024 |
Sanofi BV., Paasheuvelweg 25,1105 BP Amsterdam-The Netherlands |
Powder for concentrate for solution for infusion. | Avalglucosidase alfa 100 mg | 18 | |
| 1/9/2024 |
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, - BELGIUM |
Solution for subcutaneous injection in pre-filled syringe or prefilled pen. | Adalimumab 40 mg/0.8ml | 19 | |
| 1/9/2024 |
Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX - UNITED KINGDOM |
Powder and solvent for solution of I.V. injection. |
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
|
20 | |
| 10/9/2024 |
Alexion Europe SAS, located at 103-105 rue Anatole France, 92300 Levallois Perret, France. |
sterile aqueous solution for intravenous administration |
Ravulizumab
|
|
21 |
| 2/10/2024 |
Xiamen Innovax Biotech Co., Ltd., No. 52, Shanbianhong East Road, Haicang District, Xiamen City, Fujian Province 361027, China |
Suspension for injection in a vial. |
Human Papillomavirus Type 16L1 Protien (Recombinant) 40 mcg/0.5ml ; Human Papillomavirus Type 18L1 Protien (Recombinant) 20 mcg/0.5ml
|
21 | |
| 2/10/2024 |
instituto Grifols, S.A., Can Guasch, 2. Pol. Ind . levante, 08150 Parets del Vallès, Barcelona Spain - SPAIN |
Powder and solvent for solution for injection. |
Human Coagulation factor 50 IU/ml
|
22 | |
| 2/10/2024 |
Beijing Institute of Biological Products Co., Ltd. – Beijing Economic and Technological Development Area, Boxing 2 Road No.6, 9. - CHINA |
Oral liquid |
OPV Sabin type I 1e+006 CCID50 ; OPV Sabin type III 630957 CCID50 ;
|
23 | |
| 16/10/2024 |
Sinovac Biotech Co., Ltd., No. 39 Shangdi Xi Road, Haidian District, Beijing-China |
Suspension for intramuscular injection |
Inactivated hepatitis A virus (HAV) antigen
|
24 | |
| 14/11/2024 |
GC Biopharma Corp., 40, Sandan-gil, Hwasun-eup, Hwasun-gun, Jeollanam-do. Republic of Korea |
Solution for IM injection in Pre-filled Syringe |
GCFLU Quadrivalent
|
25 | |
| 14/11/2024 |
Mabxience Research SL.C/MANUEL POMBO Angulo 28-3a y 4a planta, 28050 Madrid -Spain |
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. |
Bevacizumab 25 mg/ml
|
26 | |
| 14/11/2024 |
Viatris Limited, Damastown Industrial Park mulhuddart, Dublin 15-Ireland |
Solution for injection Prefilled Syringe& Prefilled Pen- 40mg/0.8ml |
Adalimumab 40 mg/0.8 ml
|
27 | |
| 14/11/2024 |
Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50- 58 Baggot Street Lower, Dublin 2, D02 HW68 – Ireland. |
Solution for injection, the solution is colorless to slightly yellow, appearing either clear or slightly opalescent. -150 mg /ml |
Lanadelumab
|
28 | |
| 19/11/2024 |
Daewoong pharmaceutical
Co.Ltd., 35-14, Jeyakgondan 4-gil, Hyangnam-eup, Hwaseong-si,Gyeonggi-do-Republic of Korea.
|
Powder for solution for I.M injection
Strength:100 U/2.5 ml (4 U/0.1 mL)
|
Clostridium botulinum Toxin Type A- 100 unit
|
29 | |
| 19/11/2024 |
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd - Denmark |
Solution for injection in prefilled Pen
Strength: 100 U/ml
|
Insulin aspart 100 U/ml
|
30 | |
| 19/11/2024 |
Eva Pharma for Pharmaceutical Industries (2), Polaris Industrial District, Plot No. 27, North extensions area, 6th of October City, Giza |
Solution for injection
100 u/ml
|
INSULIN GLARGINE 100 u/ml
|
31 | |
| 19/11/2024 |
Egyptian International Pharmaceutical
Industries Company, EIPICO, Industrial Zone
B1, Tenth of Ramadan City, Egypt
|
Solution for S.C injection
Adalimumab
40 mg/0.8mL
|
Adalimumab 40 mg
|
32 | |
| 26/11/2024 |
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, - BELGIUM
|
Powder and Solvent for Solution for injection
|
RSV subgroup A stabilised prefusion F antigen 60 ug/ml;
RSV subgroup B stabilised prefusion F antigen 60 ug/ml;
|
33 | |
| 26/11/2024 |
Instituto Grifols, S.A., Can Guash 2. Pol. Ind. Levante, 08150 Parets del Valles, Barcelona spain-SPAIN
|
Solution for infusion
|
Human albumin
|
34 | |
| 26/11/2024 |
Instituto Grifols, S.A., Can Guasch, 2. Parets del Vallès, 08150 Barcelona Spain
|
solution for IV infusion
|
Human normal immunoglobulin(IV IG) 50 or 100 mg/ml
|
35 | |
| 26/11/2024 |
Fresenius Kabi Deutschland GmbH, Else-Kroner StraBe 1, 61352 Bad Homburg v.d.Hohe - GERMANY
|
Solution for injection
|
ADALIMUMAB 40 mg;
|
36 | |
| 26/11/2024 |
Wyeth Pharmaceuticals LLC, P.O. Box 8299, Philadelphia, PA 19101, United States of America.
|
Powder for concentrate for solution for infusion (powder for concentrate)
|
Gemtuzumab Ozogamicin 4.5 mg
|
37 | |
| 26/11/2024 |
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria.
|
Solution for S.C injection in Cartiadge
|
Somatropin, RH-GH 15 mg/1.5ml
|
38 | |
| 28/11/2024 |
Yuxi Walvax Biotechnology co. Ltd. No. 83 South Dongfeng Road, High and New Technology Industries Development Zone, Yuxi city, Yunnan Province - CHINA
|
lyophilized powder for reconstitution for s.c injection
|
Neisseria meningitidis group A capsular polysaccharide 50 mcg/0.5ml
• Neisseria meningitidis group C capsular polysaccharide 50 mcg/0.5ml
|
39 | |
| 5/12/2024 |
Sanofi BV.,Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands - The Netherlands
|
Powder for concentrate for solution for infusion
Strength: 20 mg/vial
|
Olipudase Alfa 20 mg
|
40 |
إدارة البروتكولات ومراجعة إجراء الدراسات- الإدارة العامة للدراسات الإكلينيكية
| Publish Date |
Sponsor |
Product Name/Dosage Form | Protocol Title | Protocol ID/Number | # |
| 9/7/2023 | F.Hoffmann-La Roche Ltd |
Giredestrant
Oral Capsules
|
A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination with Phesgo Versus Phesgo after Induction Therapy with Phesgo+ Taxane in Patients with Previously Untreated Her2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer(HeredERA) | WO43571 | 1 |
| 21/7/2024 | Minapharm Pharmaceuticals and Chemical Industries S.A.E |
Adessia "MP-ADA1"
|
Phase I, randomized, double-blind, 2-arm, parallel group trial to compare pharmacokinetics of Adessia with EU-authorized Humira in healthy male and female participants | MP-ADA1-01 | 2 |
| 26/9/2024 | Nerhadou International |
(Nerkardou)
Bisoprolol 5mg ,10 mg
Oral dissolvable film
|
A prospective, Multicentre, Open-label, Single-arm Interventional Study of Bisoprolol
(Nerkardou) (Between Low Dose and High Dose) 5 and 10 mg ODF Treatment In Egyptian Patients
with Essential Hypertension
|
GRC/NE-CV/EG/39/IV | 3 |