EDA Logo
عفواً , الموقع لا يدعم هذا المتصفح

الإدارة المركزية للمستحضرات الحيوية والمبتكرة والدراسات الإكلينيكية

التقرير العلمي العام -٢٠٢٦

التقرير العلمي العام 2026

Product Name  Scientific Name Dosage Form Marketing Authorization Holder (MAH) Publish Date
​Vyloy  Zolbetuximab Lyophilized powder for Concentrate for solution for I.V infusion Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE LEIDEN- The Netherlands 19/5/2026
Tremfya

Guselkumab 200 mg /20.0 ml(10mg/ml)

Guselkumab 200 mg in 2 mL solution (PFP).

Concentrate for solution for I.V infusion,

Guselkumab 200 mg /20.0 ml(10mg/ml).

- Solution for subcutaneous injection in pre-filled pen,

Each pre-filled pen contains: Guselkumab 200 mg in 2 mL solution

- Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse - Belgium.

19/5/2026
Rota Teq

One dose (2 ml) contains rotavirus type*:

G1             ≥ 2.2 x 106 IU¹

 G2            ≥2.8 x 106 IU¹

G3               2.2 x 106 IU¹

G4              2.0 x 106 IU¹

P1A[8]        2.3 x 106 IU¹

* Human-bovine rotavirus reassortants (live), produced in Vero cell.

1 Infectious Units.

Oral Solution Merck sharp & Dohme Corp., asubidiary of merck &co., Inc,1 Merck Drive, P.o Box 100, Whitehouse Station, NJ 08889, US,License #0002. 14/5/2026
​Norditropin

SOMATROPIN, RH-GH

Solution for injection

Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsvaerd, Denmark - DENMARK

14/5/2026
​Hep B 1 and 10 dose

Each dose of 0.5ml contains:

Purified Hepatitis B Surface Antigen 10 µg.

Preservative Thiomersal 0.005 %.

Produced in hansenula polmorph (yeast) Adsorbed on aluminum hydroxide (AL +++) 0.25 mg to 0.40 mg.

Suspension for intramuscular injection 

Serum Institute of India Pvt. Ltd., 212/2, Hadapsar, Pune 411028 Maharashtra State - India.

30/04/2026
Varicella Vaccine

Active immunization for the prevention of
varicella in individuals aged 1 year (12 months)
and above

Lyophilized Powder for Injection

Sinovac (Dalian) Vaccine Technology Co., Ltd.,No. 36, 2nd Life Road, DD Port, Economic and Technical Development Zone, Dalian, Liaoning Province, P.R - CHINA

05/04/2026
immunorho

Human Anti-D Immunoglobulin

300mcg /2ml Solution for injection in Pre-filled
Syringe
Kedrion S.P.A LOCALITA AL CONTI -
FRAZIONE DI CASTELVECCHIO PASCOLI
55051-BARGA (LU) - ITALY
26/03/2026
fanhdi
Human Coagulation Factor VIII and Von
Willebrand Factor (VWF)
Powder and Solvent for Solution for injection 
Instituto Grifols, S.A., Can Guasch, 2. Pol. Ind.
levante, 08150 Parets del Vallès, Barcelona Spain
- SPAIN
16/03/2026
Vaxigrip

Haemagglutinin of:

A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/9/2021, IVR-228) 15 mcg; A/Victoria/4897/2022 (H1N1) pdm09-like strain (A/Victoria/4897/2022, IVR-238) 15 mcg

B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type) 15 mcg;

Suspension in prefilled syringe
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly. - FRANCE;
01/03/2026
Fabrazyme
Agalsidase beta
Powder for concentrate for solution for infusion (35 mg/vial)
Sanofi BV.,Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
24/2/2026
Prevenar 20

Pneumococcal Polysaccharide Serotype (1,3,4,5,6A,7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) 2.2 ug ;

Pneumococcal Polysaccharide Serotype (6B) 4.4 ug 

Suspension for injection
0.5mL single-dose prefilled syringe
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgium - BELGIUM
12/2/2026
Havrix
HAV antigen 720 Elisa units (E.L.U)
adsorbed on Aluminium hydroxide AL
0.25mg
Suspension for injection
GlaxoSmithKline Biologicals s.a., 89, rue de l'Institut, 1330 Rixensart -
Belgium.
4/1/2026
Engerix B Adult - Paediatric
Hepatitis B surface antigen 20 mcg/ml
Suspension for injection
GlaxoSmithKline Biologicals s.a., 89, rue de l'Institut, 1330 Rixensart -
Belgium.
4/1/2026
Measles and Rubella Vaccine
Measles Virus and Rubella Virus
Powder and Solvent for injection
Queen trading office QTO - Bimag Pharma
4/1/2026
weuphoria

1-Pneumococcal polysaccharide serotype (1) 2.6 mcg/0.5ml.

  1. Pneumococcal polysaccharide serotype (14) 2.75 mcg/0.5ml.
  2. Pneumococcal polysaccharide serotype(18C) 3.25 mcg/0.5ml.
  3. Pneumococcal polysaccharide serotype (19A )2.6 mcg/0.5ml.
  4. Pneumococcal polysaccharide serotype(19F) 2.75 mcg/0.5ml.
  5. Pneumococcal polysaccharide serotype(23F) 3 mcg/0.5ml.
  6. Pneumococcal polysaccharide serotype (3) 2.5 mcg/0.5ml.
  7. Pneumococcal polysaccharide serotype (4) 3 mcg/0.5ml.
  8. Pneumococcal polysaccharide serotype (5)2.5 mcg/0.5m.
  9. Pneumococcal polysaccharide serotype(6A)2.5 mcg/0.5ml.
  10. Pneumococcal polysaccharide serotype(7F)2.85 mcg/0.5m.
  11. Pneumococcal polysaccharide serotype(9V)2.5 mcg/0.5ml.

13.Pneumococcal polysaccharide serotype(6B)6.0 mcg/0.5ml.

Bulk Purified Tetanus Toxoid 41-150 mcg/0.5ml.

Suspension for IM injection
Yuxi Walvax Biotechnology co. Ltd. No. 83 South Dongfeng Road, High and New Technology Industries Development Zone, Yuxi city, Yunnan Province - CHINA;
4/1/2026

Pneumococcal polysaccharide serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F conjugated to CRM197 carrier protein and adsorbed on aluminum phosphate (0.125 mg aluminum)Bulk Purified Tetanus Toxoid 41-150 mcg/0.5ml.

Suspension for injection in a pre-filled syringe
Pfizer –Egypt
4/1/2026

 

جميع الحقوق محفوظة لدي هيئة الدواء 2021