EDA Logo
عفواً , الموقع لا يدعم هذا المتصفح

الإدارة االعامة للمستحضرات الحيوية -إدارة التسجيل

التقرير العلمي العام -٢٠٢٦

التقرير العلمي العام 2026

Product Name  Scientific Name Dosage Form Marketing Authorization Holder (MAH)
Nepexto
ETANERCEPT
Solution for injection in pre-filled syringe or pre-filled pen Biosimilar Collaborations Ireland limited (BCIL), 35/36, grange parade, Baldoyle industrial estate, Dublin 13 - Ireland.
Priorix
Live attenuated measles virus, Live attenuated mumps virus and Live attenuated rubella virus
Powder and Solvent for Solution for Injection
GlaxoSmithKline Biologicals S.A
89 Rue de l’institut
1330 Rixensart
Belgium
Euvax B 
Purified Hepatitis B surface antigen.
Solution for injection. LG Chem, Ltd.
DTP Hep Hib
Diphtheria Toxoid ≤ 25 Lf (≥ 30 IU).
Tetanus Toxoid ≥ 2.5 Lf (≥ 40 IU).
B. Pertussis (whole cell) ≤ 16 OU (≥ 4 IU).
HBsAg (rDNA) ≥ 10 mcg.
Purified Capsular Hib Polysaccharide (PRP) conjugated to Tetanus Toxoid (carrier protein) 10 mcg.
Adsorbed on aluminum phosphate, Al3+ ≤ 1.25 mg
Thiomersal 0.005 %.
Suspension for intramuscular injection Serum Institute of India Ltd., 212/2, Hadapsar, Pune 411028, Maharashtra, India
Hympavzi 
Marstacimab
Solution in prefilled pen Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001-USA
Cervarix
Human papilloma virus
Suspension for injection GlaxoSmithKline Biologicals S.A., Rue de l'Institut 89, B-1330 Rixensart – Belgium.
Trastuza
Trastuzumab 440 mg
1 multidose vial of Trastuza 440 mg lyophilized Powder + 20 ml clear glass vial of WFI Egyptian International Pharmaceutical Industries Company (EIPICO) - EGYPT
Gardasil4
Type 6 L1 Protein.
Type 11 L1 Protein.
Type 16 L1 Protein.
Type 18 L1 Protein
 Vial for Injection Merck Sharp and Dohme Corp
Hibrex 
Haemophilus influenza type b polysaccharide   10 µg
Conjugated to Tetanus toxoid as carrier protein      Approximately 25 µg.
Powder and solvent for solution for injection
Glaxo Smith kline Biologicals S.A.
89 Rue de l’ inistitut
1330 Rixensart -Belgium
DT(pediatric)Vaccine Pool of Purified Diphtheria Toxoid, Pool of Purified Tetanus Toxoid Suspension for injection. Serum Institute of India Ltd.; 212/2, Hadapsar, Pune-411 028, M.S., India
BCG Bacillus Calmette-Guerin lyophilized powder to be reconstituted with the diluent
. Serum Institute of India Pvt. Ltd., (SIIPL),
212/2, Hadapsar, Pune – 411028, India
Stamaril Yellow fever virus strain 17D-204 (live, attenuated) at least 1000 IU per dose Powder and solvent in PFS Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly-France.
verorab Inactivated rabies virus (wister rabies virus strain PMW1 38-1503-3M) ≥ 2.5 IU  Powder and solvent in PFS Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentilly-France
Twinrix Adult
Hepatitis A virus antigen (HM 175 strain) 720 ELISA Units
r-DNA Hepatitis B virus surface antigen (HBsAg) 20 mcg
Suspension for injection GlaxoSmithKline Biologicals S.A., Rue de l'Institut 89, B-1330 Rixensart - Belgium.
Rabies vaccine for Human use (vero cell) Purified and inactivated rabies whole virus existed in the form of purified bulk. Lyophilized powder for reconstitution
In Country of origin:
Liaoning Cheng Da Biotechnology Co., Ltd, Shenyang, China
In Egypt :
Egyptian Company for Production of Vaccines , Sera and Drugs ( EGYVAC ), 51 Wezaret El Zeraa Street , Agouza , Giza , Egypt.
Varlirix Live attenuated varicella virus (OKA strain)  ≥ 2000 PFU Powder and solvent in PFS GlaxoSmithKline Biologicals SA, Rue de l'Institut, 89, 1330 Rixensart - Belgium
Winrevair Sotatercept Powder and solvent for solution for injection  Merck Sharp & Dohme B.V., the Netherlands
Elahere Mirvetuximab Soravtansine Liquid formulation for intravenous (IV) AbbVie Deutschland GmbH - Germany
Nucala Mepolizumab Solution of 100 mg for SC injection in prefilled pen GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, IRELAND
Jubbonti Denosumab 60mg/1ml Solution for SC injection Sandoz GmbH Biochemiestrasse 10 6250 Kundl - AUSTRIA
Wyost Denosumab Solution for SC injection Sandoz GmbH Biochemiestrasse 10 6250 Kundl - AUSTRIA
​Vyloy  Zolbetuximab Lyophilized powder for Concentrate for solution for I.V infusion Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE LEIDEN- The Netherlands
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.

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.
​Norditropin

SOMATROPIN, RH-GH

Solution for injection

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

​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.

Varicella Vaccine, Live

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

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
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
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;
Fabrazyme
Agalsidase beta
Powder for concentrate for solution for infusion (35 mg/vial)
Sanofi BV.,Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
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
Havrix Junior 720
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.
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.
Measles and Rubella Vaccine
Measles Virus and Rubella Virus
Powder and Solvent for injection
Queen trading office QTO - Bimag Pharma
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;

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

 

جميع الحقوق محفوظة لدي هيئة الدواء 2021