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 |