التقرير العلمي العام -2025
| Product Name | Scientific Name | Dosage Form | Marketing Authorization Holder (MAH) | Publish Date |
| Avaxim | Inactivated Hepatitis A vaccine | pre-filled syringe | Sanofi Pasteur | 15/12/2025 |
| Euvichol-plus | OCV (Oral Inactivated Cholera vaccine) | Suspension with a yellow to yellowish color | Eubiologics Co. LTD Basement, 1F, 2-4~2-6, 3-1~3-4 and 4-6 of 4-dong and outdoor cold storage room 3~8, 56 Soyanggang-ro, Chuncheon-si, Gangwon-do, 24232, Republic of Korea - REPUBLIC OF KOREA | 15/12/2025 |
| Haemate |
Human Coagulation Factor VIII 250 IU / 600 IU
Human von Willebrand Factor
Human Coagulation Factor VIII 500 IU / 1200 IU
Human von Willebrand Factor
|
Powder and solvent for solution for injection | CSL Behring GmbH Emil-von-Behring-StraBe 76 35041 Marburg - GERMANY; | 15/12/2025 |
| Octanine F 100 | Human Coagulation Factor IX 500 IU (100 IU/ml) | Powder and solvent for solution for IV injection | Octapharma Pharmazeutika Produktionsges m.b.H, Oberlaaerstraβe 235, 1100 Wien - Austria | 15/12/2025 |
| Rotarix | Live attenuated human rotavirus | 1.5 ml containing not less than 106.0 CCID50 of live attenuated Rotavirus. | GlaxoSmithKline Biologicals S.A | 15/12/2025 |
| V210_Egypt varivax | Oka/Merck Varicella Virus live attenuated | Powder & solvent for suspension for subcutaneous injection | Merck, Sharp & Dohme, LLC, P.O. Box 4, West Point, PA 19486 – USA. | 15/12/2025 |
| wegovy | Semaglutide | Solution for Subcutaneous injection in prefilled pen flex touch | Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd- Denmark - DENMARK; | 15/12/2025 |
| Eupolio | Eupolio | Solution for IM injection | LG Chem Ltd. | 9/12/2025 |
| Basalin | Insulin glargine | Solution for injection in a cartridge | Gan and Lee Pharmaceuticals No. 8 Nanfeng West 1st Street, Huoxian, Tongzhou District, Beijing 101109, China - CHINA. | 7/12/2025 |
| Barycela | BARYCELA inj. (Live Attenuated Varicella Virus Vaccine) | Lyophilized Powder for recantation for S.C Injection | VACSERA | 3/12/2025 |
| TT Biopharma |
Each dose (0.5 ml) contains:
Purified Tetanus toxoid 10 Lf
|
suspension for Injection | PT. Bio Farma, Jl. Pasteur No. 28, Bandung 40161- Indonesia. | 1/12/2025 |
| Tripvac |
Each dose 0.5 ml contains:
· Diphtheria toxoid: 25 Lf (≥ 30 IU)
· Tetanus toxoid: 5.5 Lf (≥ 60 IU)
· B. Pertussis 16 IOU (≥ 4.0IU)
Adsorbed on Aluminum phosphate (AlPO4) ≥ 1.5 mg.
|
Suspension for injection |
Diphtheria toxoid and whole cell pertussis:
Biological E. limited, Plot No.1, S.P. Biotechnology Park, Phase-II, Kolthur Village, Shameerpet Mandal, Medchal-Malkajgiri District-500 078, Telangana-India.
· Tetanus Toxoid:
Biological E. limited,7-4-114, Gaganpahad, Rajendra Nagar Mandal, Ranga Reddy District, Telangana 501 323-India.
|
1/12/2025 |
| Synflorix |
Each one dose 0.5 ml contains:
Pneumococcal polysaccharide serotypes 1 (1µg), 4 (3µg), 5(1µg), 6B (1µg), 7F (1µg), 9V (1µg), 14 (1µg), 18C (3µg), 19F (3µg), 23F (1µg)
* adsorbed on aluminum phosphate 0.5 mg, conjugated to protein D (derived from non-typeable Haemophilus infleunzae) carrier protein 9-16 µg, conjugated to tetanus toxoid carrier protein 5-10 µg, conjugated to diphtheria toxoid carrier protein 3-6 µg
|
Suspension for injection in vial | GlaxoSmithKline Biologicals s.a., Rue de l ʼ Institut 89, B-1330 Rixensart-Belgium | 1/12/2025 |
| prevenar 13 multidose | Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) | Suspension for injection in multi-dose container | Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles-Belgium | 1/12/2025 |
| Polio GSK | Live attenuated poliovirus Type 1 or 3 | oral | GlaxoSmithKline Biologicals SA | 1/12/2025 |
| Polio Biovac | live attenuated poliovirus type 1 and 3 Sabin Strain | Oral |
PT Bio Farma(Persero) (as per the 1st page of the TAR) |
1/12/2025 |
| Polio Bilthoven | Inactivated Poliomyelitis virus type 1 (40 D Antigen Units); Inactivated Poliomyelitis virus type 2 (8 D Antigen Units); Inactivated Poliomyelitis virus type 3 (32 D Antigen Units) | Suspension for injection | Bilthoven Biologicals B.V. Antonie van Leeuwenhoeklaan 9-13 3721 MA Bilthoven The Netherlands | 1/12/2025 |
| Pneumovax |
Mixture of purified capsular polysaccharides from 23 serotypes of Streptococcus pneumoniae
(Serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F)
|
Solution for injection in pre-filled syringe | Merck Sharp & Dohme Corp., P.O. Box 4, West Point, PA 19486 - USA | 1/12/2025 |
| Pneumosil | Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed) | Suspension for injection | SERUM INSTITUTE OF INDIA PVT. LTD. 212/2, Hadapsar, Pune 411028, INDIA. | 1/12/2025 |
| DTPHep B |
Each dose of 0.5 ml contains:
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 |
1/12/2025 |
| IPV biogeneric |
Poliovirus (Inactivated)Type I (Sabin) 15 DU;
Poiliovirus (Inactivated) Type II (Sabin) 45 DU;
Poliovirus (Inactivated) Type III(Sabin) 45DU;
|
Suspension for injection |
Beijing Institute of Biological Products Co., Ltd., No.6,9 Bo’xing 2nd Road, Economic-Technological Development Area,Beijing-P.R.CHINA.; |
1/12/2025 |
| Oral Bivalent Sanofi |
Each 0.1ml dose (2 drops) contains:
Poliomyelitis virus type 1, LS c2ab strain (live, attenuated) at least 6.0 log CCID50.
Poliomyelitis virus type 3, Leon 12a1b strain (live, attenuated) at least 5.8 log CCID50.
|
Oral suspension in multi-dose vial. | Sanofi Pasteur S.A., 2, avenue Pont Pasteur, 69007 Lyon – France. | 1/12/2025 |
| Nimenrix |
Neisseria meningitidis group A polysaccharid Neisseria meningitidis group C polysaccharide Neisseria meningitidis group W-135 polysaccharide Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein |
Powder and solvent for solution for injection |
GlaxoSmithKline Biologicals S.A., 89, rue de l'Institut, B-1330 Rixensart - Belgium |
1/12/2025 |
| MMR 2,5,10 doses (SII) | Measles Virus, Mumps Virus and Rubella Virus | Powder and Solvent for injection |
Serum Institute of India Pvt. Ltd, 212/2, Hadapsar, Pune 411028 Maharashtra State – India |
1/12/2025 |
| DT Vaccine | Diphtheria and Tetanus Vaccine Adsorbed for Adults and Adolescents | Suspension for injection |
Serum Institute of India PVT. LTD. 212/2, Hadapsar, Pune 411028 Maharashtra state-INDIA |
1/12/2025 |
| Comb Five |
Each dose of 0.5ml contains: Diphtheria Toxoid 25LF (≥30 IU) Tetanus Toxoid 5.5LF (≥60 IU) Pertussis (Whole cell) 16 IOU (≥4IU) r-HBsAg 12.5µg purified capsular polysaccharide of Hib (PRP) covalently linked to 20 to 36.7µg of Tetanus Toxoid 11µg Al+++ (as AlPO4) ≤1.25mg Preservative: Thiomersal Ph.Eur./BP 0.01% w/v |
Suspension for intramuscular injection | Biological E. Limited, plot No.1, S.P. Biotechnology Park, Phase-II, Kolthur Village, Shameerpet Mandal, Ranga Reddy District - 500 078, Telangana - India | 1/12/2025 |
| Arexvy |
Respiratory Syncytial Virus recombinant glycoprotein F stabilized in the pre-fusion conformation Ant 120 mcg/0.5m |
preservative-free suspension for intramuscular injection |
GlaxoSmithKline Biologicals s.a., Rue de l' institute 89, B-1330 Rixensart-Belgium |
1/12/2025 |
| Adsorbed tetanus |
Each dose 0.5ml contains tetanus toxoid ≥ 40 IU
Adsorbed on Aluminium Phhosphate (AIPO) ≥ 1.5mg
Preservative: Thiomersal 0.01%
|
Suspension for intramuscular injection | M/s Biological E. Limited, Plot No. 1, Biotech Park, Phase II, Kolthur Village, Shameerpet, Medchal-Malkajgiri District – 500 078, Telangana - INDIA | 1/12/2025 |
| Adsorbed TD |
Each 0.5 ml contains: Purified Tetanus Toxoid : 7.5 Lf/dose Purified Diphtheria Toxoid 2 Lf/dose |
Suspension for injection |
Biovac Egypt for Drugs, Sera and Vaccines, 7 Taha Hussein Street, Madkor, Giza - Egypt. |
1/12/2025 |
| Influvac Tetra |
Influenza virus surface antigens (inactivated) (haemagglutinin* and neuraminidase) of the following strains: - A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) 15 µg HA* - A/Croatia/10136RV/2023 (H3N2)-like strain (A/Croatia/10136RV/2023, X-425A) 15 µg HA* - B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) 15 µg HA* - B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type) 15 µg HA* |
Suspension for intramuscular or subcutaneous injection |
Abbott Biologicals B.V. C.J van Houtenlaan 36 NL-1381 CP Weesp The Netherlands |
25/11/2025 |
| V210-VARIVAX | Oka/Merck Varicella Virus live attenuated 1350 PFU | Powder & solvent for suspension for subcutaneous injection | Merck, Sharp & Dohme, LLC, P.O. Box 4, West Point, PA 19486 – USA. | 24/11/2025 |
| BETD | Diphtheria Toxoid and Tetanus toxoid | intramuscular injection |
Biological E. Limited. Plot No. 1, S.P., Biotechnology Park, Phase-11, Kolthur Village, Shameerpet , Ranga Reddy District-500 078, Telangana, India |
19/11/2025 |
|
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 |
Solution for Intramuscular Injection | Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370- USA | 16/11/2025 | |
| Easy Five |
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 |
Suspension for intramuscular injection | Panacea Biotec LTD. (vaccine division), Village Malpur, Baddi, Dist. Solan (HP), 173205 - India | 6/11/2025 |
| Havrix | HAV antigen 720 Elisa units (E.L.U) adsorbed on Aluminium hydroxide AL 0.25mg | Suspension for injection | GlaxoSmithKline Biologicals SA, 89, rue de I'Institut, B-1330 Rixensart – Belgium. | 3/11/2025 |
| Penta | Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenza type b conjugate | Suspension for IM injection |
The holding company for biological products and vaccines (VACSERA)-building (60)/ building (1)-51 wezarat el zeraa street - agouza -Giza-Egypt - EGYPT |
23/10/2025 |
| Vaxirab | 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 | 7/10/2025 |
| Rabivax | 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 | 2/10/2025 |
| Humaxin Tard | Human Insulin Isophane 100 I.U./ml | Suspension for S.C injection | Evapharma for Pharmaceutical Industries (2), Polaris Industrial District, Plot No. 27, North extensions area, 6th of October City, Giza - EGYPT | 28/9/2025 |
| OMALIZUMAB | Solution for injection in Pre-filled Syringe | Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4 – IRELAND. | 18/9/2025 | |
| Tecentriq | Atezolizumab | Solution for injection | Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen - Germany – GERMANY. | 3/9/20285 |
| MSD Vaxneuvance |
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 |
Suspension for injection in prefilled syringe | Merck Sharp and Dohme B.V. Waarderweg 39 2031 BN Haarlem - The Netherlands | 2/9/2025 |
| Metalyse | TENECTEPLASE 25 mg | Powder for Solution for IV Injection |
Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein - GERMANY |
7/8/2025 |
| Influvac |
Haemagglutinin of:
|
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 |
Abbott Biologicals B.V.C.J van Houtenlaan 36, NL-1381 CP Weesp- The Netherlands |
7/8/2025 |
| tepkinly | Epcoritamab |
Solution for injection 5 mg/ml (4mg epcoritamab/0.8ml) 60 mg/ml (48mg epcoritamab/0.8ml) |
Abbvie Deutschland GmbH and Co KG, Knollstrasse, 67061 Ludwigshafen - GERMANY | 7/8/2025 |
| ocrevus 920 | Ocrelizumab 920 mg/23ml | Solution for injection | Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen - Germany | 7/8/2025 |
| Jemperli | Dostarlimab 500 mg/10ml | IV INFUSION | GlaxoSmithkline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24 - IRELAND | 7/8/2025 |
| Humaxin rapid | Insulin human100 u/ml | Solution for injection |
Evapharma for Pharmaceutical Industries (2) , Polaris Industrial District, Plot No. 27, North extensions area, 6th of October City, Giza |
7/8/2025 |
| Humaxin mix |
Soluble human insulin 30% / human insulin isophane (NPH) 70% 100 I.U./ml |
Suspension for SC injection 100 I.U./ml | Evapharma for Pharmaceutical Industries (2) , Polaris Industrial District, Plot No. 27, North extensions area, 6th of October City, Giza | 7/8/2025 |
| actemra | Tocilizumab 162 mg/0.9ml | Solution for subcutaneous injection in prefilled syringe |
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen - Germany |
7/8/2025 |