للاطلاع على تقارير التقييم العلمي العام برجاء الضغط على الرابط ( مصدر باللغة الأنجليزية)
CA Of biologicals product and Innovation and Clinical study
| 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 | |
| 7/08/2025 |
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen - Germany
|
Solution for subcutaneous injection in prefilled syringe
|
Tocilizumab 162 mg/0.9ml
|
41 | |
| 7/08/2025 |
Evapharma for Pharmaceutical Industries (2) , Polaris Industrial District, Plot No. 27, North extensions area, 6th of October City, Giza - EGYPT
|
Suspension for SC injection 100 I.U./ml
|
Soluble human insulin 30% / human insulin isophane (NPH) 70% 100 I.U./ml
|
42 | |
| 7/08/2025 |
Evapharma for Pharmaceutical Industries (2) , Polaris Industrial District, Plot No. 27, North extensions area, 6th of October City, Giza
|
Solution for injection
|
Insulin human100 u/ml
|
43 | |
| 7/8/2025 |
GlaxoSmithkline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24 - IRELAND
|
IV INFUSION
|
Dostarlimab 500 mg/10ml
|
44 | |
| 7/8/2025 |
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen - Germany
|
Solution for injection
|
Ocrelizumab 920 mg/23ml
|
ocrevus 920 | 45 |
| 7/8/2025 |
Abbvie Deutschland GmbH and Co KG, Knollstrasse, 67061 Ludwigshafen - GERMANY
|
Solution for injection
5 mg/ml (4mg epcoritamab/0.8ml)
60 mg/ml (48mg epcoritamab/0.8ml)
|
Epcoritamab
|
46 | |
| 7/8/2025 |
Abbott Biologicals B.V.C.J van Houtenlaan 36, NL-1381 CP Weesp- The Netherlands
|
Surface antigens haemagglutinin and neuraminidase; 0.5 ml of the vaccine suspension for injection contains 15 microgram of the antigen haemagglutinin of each recommended virus strain
|
Haemagglutinin of:
• A/Victoria/4897/2022 (H1N1) pdm09-like strain (A/Victoria/4897/2022, IVR-238) 15 μg
• A/Thailand/8/2022 (H3N2)-like strain (A/California/122/2022, SAN-022) 15 μg
•B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) 15 μg
|
47 | |
| 7/8/2025 |
Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein - GERMANY
|
Powder for Solution for IV Injection
|
TENECTEPLASE 25 mg
|
48 | |
| 2/9/2025 |
Merck Sharp and Dohme B.V. Waarderweg 39 2031 BN Haarlem - The Netherlands
|
Suspension for injection in prefilled syringe
|
Pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F 2 mcg/0.5ml
Pneumococcal polysaccharide serotype 6B
4 mcg/0.5ml
conjugated to CRM 197 carrier protein ~30 mcg/0.5ml
|
49 | |
| 3/9/20285 |
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen - Germany – GERMANY.
|
Solution for injection
|
Atezolizumab
|
50 | |
| 18/9/2025 |
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4 – IRELAND.
|
Solution for injection in Pre-filled Syringe
|
OMALIZUMAB
|
75 mg/0.5ml and 150 mg/ml
|
51 |
| 28/9/2025 |
Evapharma for Pharmaceutical Industries (2), Polaris Industrial District, Plot No. 27, North extensions area, 6th of October City, Giza - EGYPT
|
Suspension for S.C injection
|
Human Insulin Isophane 100 I.U./ml
|
52 | |
| 2/10/2025 |
Purified Rabies Antigen (Rabies virus Pitman-Moore Strain 3218-VERO adapted and grown on vero cells, inactivated by using b - propiolactone) not less than 2.5 IU Reconstitute with 1 ml of Sterile Water for Injections.
|
Lyophilized powder not less than 2.5 IU
|
Serum institute of india PVT.LTD.212/2,Hadapsar pune 411028 Maharashtra state, India
|
53 | |
| 7/10/2025 |
Inactivated Rabies Virus (Pitman Moore Strain) ≥2.5 I.U/VIAL
|
Lyophilized Powder
|
Zydus Lifesciences Limited., Survey No. 417, 419 &420, Sarkhej Bavla National highway No.8 A, Village-Moraiya, Tal Sanand, city: Moraiya -382 210 Dist Ahmedabad -382 210 Gujarat state, INDIA
|
54 | |
| 23/10/2025 |
The holding company for biological products and vaccines (VACSERA)-building (60)/ building (1)-51 wezarat el zeraa street - agouza -Giza-Egypt - EGYPT
|
Suspension for IM injection
|
Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenza type b conjugate
|
55 | |
| 3/11/2025 |
GlaxoSmithKline Biologicals SA, 89, rue de I'Institut, B-1330 Rixensart – Belgium.
|
Suspension for injection
|
HAV antigen 720 Elisa units (E.L.U) adsorbed on Aluminium hydroxide AL 0.25mg
|
56 | |
| 6/11/2025 |
Panacea Biotec LTD. (vaccine division), Village Malpur, Baddi, Dist. Solan (HP), 173205 - India
|
Suspension for intramuscular injection
|
Each dose of 0.5ml
contains:
Diphtheria Toxoid 20LF (30 IU)
Tetanus Toxoid 7.5LF (60 IU)
Inactivated w B. Pertussis 12 IOU (4IU)
r-HBsAg 10 µg
Hib polyssacharide conjugated to Tetanus Toxoid (PRP-TT) 10µg
Al+++ (as Aluminium Phosphate Gel) 0.25mg
Preservative: Thiomersal 0.025mg
|
||
| 16/11/2025 |
Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370- USA
|
Solution for Intramuscular Injection
|
Each 0.5 ml contain
Meningococcal (Serogroup A) polysaccharide (monovalent conjugate) 4µg
Meningococcal (Serogroup C) polysaccharide (monovalent conjugate) 4µg
Meningococcal (Seogroup Y) polysaccharide (monovalent conjugate) 4µg
Meningococcal (Seogroup W135) polysaccharide (monovalent conjugate) 4µg
Diptheria Toxoid protein 48µg
|
57 | |
| 19/11/2025 |
Biological E. Limited. Plot No. 1, S.P., Biotechnology Park, Phase-11, Kolthur Village, Shameerpet , Ranga Reddy District-500 078, Telangana, India
|
intramuscular injection
|
Diphtheria Toxoid and Tetanus toxoid
|
Protocol Management and Study Procedure Review – General Directorate of Clinical Studies
| 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 |