EDA-CT Application(s) Assessment Summary Publication Report (CT-ASPR) 2023-2024
|
Protocol ID/Number |
Protocol Title |
Product Name/ Dosage Form |
Sponsor |
Publishng Date |
| WO43571 |
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).
|
Giredestrant
Oral Capsules
|
F.Hoffmann- La Roche Ltd |
9/7/2023 |
| MP-ADA1-01 | 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 | Adessia "MP-ADA1" | Minapharm Pharmaceuticals and Chemical Industries S.A.E | 21/7/2024 |
| GRC/NE-CV/EG/39/IV |
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 |
(Nerkardou)
Bisoprolol 5mg ,10 mg
Oral dissolvable film
|
Nerhadou Internationa | 26/9/2024 |