تقارير التقييم العام PAR

الإدارة المركزية للمستحضرات الحيوية والمبتكرة والدراسات الإكلينيكية

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

 

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

 

 

 

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