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 |
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 |