النقرير العلمي العام
| Product Name | Scientific Name | Dosage Form | Marketing Authorization Holder (MAH) | Publish Date |
| Xenpozyme | Olipudase Alfa 20 mg |
Powder for concentrate for solution for infusion
Strength: 20 mg/vial
|
Sanofi BV.,Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands - The Netherlands | 5/12/2024 |
| Group A and C Meningococcal Polysaccharide Vaccine |
Neisseria meningitidis group A capsular polysaccharide 50 mcg/0.5ml
• Neisseria meningitidis group C capsular polysaccharide 50 mcg/0.5ml
|
lyophilized powder for reconstitution for s.c injection | Yuxi Walvax Biotechnology co. Ltd. No. 83 South Dongfeng Road, High and New Technology Industries Development Zone, Yuxi city, Yunnan Province - CHINA | 28/11/2024 |
| Omnitrope | Somatropin, RH-GH 15 mg/1.5ml | Solution for S.C injection in Cartiadge | Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria. | 26/11/2024 |
| Mylotarg | Gemtuzumab Ozogamicin 4.5 mg | Powder for concentrate for solution for infusion (powder for concentrate) | Wyeth Pharmaceuticals LLC, P.O. Box 8299, Philadelphia, PA 19101, United States of America. | 26/11/2024 |
| Idacio | ADALIMUMAB 40 mg | Solution for injection | Fresenius Kabi Deutschland GmbH, Else-Kroner StraBe 1, 61352 Bad Homburg v.d.Hohe - GERMANY | 26/11/2024 |
| Human normal immunoglobulin(IV IG) 50 or 100 mg/ml | solution for IV infusion | Instituto Grifols, S.A., Can Guasch, 2. Parets del Vallès, 08150 Barcelona Spain | 26/11/2024 | |
| Abrysvo |
RSV subgroup A stabilised prefusion F antigen 60 ug/ml;
RSV subgroup B stabilised prefusion F antigen 60 ug/ml;
|
Powder and Solvent for Solution for injection | Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, - BELGIUM | 26/11/2024 |
| Human Albumin | Human albumin | Solution for infusion | Instituto Grifols, S.A., Can Guash 2. Pol. Ind. Levante, 08150 Parets del Valles, Barcelona spain-SPAIN | 26/11/2024 |
| adalimab | Adalimumab 40 mg |
Solution for S.C injection
Adalimumab
40 mg/0.8mL
|
Egyptian International Pharmaceutical
Industries Company, EIPICO, Industrial Zone
B1, Tenth of Ramadan City, Egypt
|
19/11/2024 |
| glargivin | INSULIN GLARGINE 100 u/ml |
Solution for injection
100 u/ml
|
Eva Pharma for Pharmaceutical Industries (2), Polaris Industrial District, Plot No. 27, North extensions area, 6th of October City, Giza
|
19/11/2024 |
| fiasp | Insulin aspart 100 U/ml |
Solution for injection in prefilled Pen
Strength: 100 U/ml
|
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd - Denmark
|
19/11/2024 |
| NABOTA | Clostridium botulinum Toxin Type A- 100 unit |
Powder for solution for I.M injection
Strength:100 U/2.5 ml (4 U/0.1 mL)
|
Daewoong pharmaceutical
Co.Ltd., 35-14, Jeyakgondan 4-gil, Hyangnam-eup, Hwaseong-si,Gyeonggi-do-Republic of Korea.
|
19/11/2024 |
| Lanadelumab |
Solution for injection, the solution is colorless to slightly yellow, appearing either clear or slightly opalescent. -150 mg /ml
|
Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50- 58 Baggot Street Lower, Dublin 2, D02 HW68 – Ireland.
|
14/11/2024 | |
| Hulio | Adalimumab 40 mg/0.8 ml |
Solution for injection Prefilled Syringe& Prefilled Pen- 40mg/0.8ml
|
Viatris Limited, Damastown Industrial Park mulhuddart, Dublin 15-Ireland
|
14/11/2024 |
| Alymsys | Bevacizumab 25 mg/ml |
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.
|
Mabxience Research SL.C/MANUEL POMBO Angulo 28-3a y 4a planta, 28050 Madrid -Spain
|
14/11/2024 |
| GC flu | GCFLU Quadrivalent |
Solution for IM injection in Pre-filled Syringe
|
GC Biopharma Corp., 40, Sandan-gil, Hwasun-eup, Hwasun-gun, Jeollanam-do. Republic of Korea
|
14/11/2024 |
| Healive | Inactivated hepatitis A virus (HAV) antigen |
Suspension for intramuscular injection
|
Sinovac Biotech Co., Ltd., No. 39 Shangdi Xi Road, Haidian District, Beijing-China
|
16/10/2024 |
| Polio | OPV Sabin type I 1e+006 CCID50 ; OPV Sabin type III 630957 CCID50 ; |
Oral liquid
|
Beijing Institute of Biological Products Co., Ltd. – Beijing Economic and Technological Development Area, Boxing 2 Road No.6, 9. - CHINA
|
2/10/2024 |
| factor IX | Human Coagulation factor 50 IU/ml |
Powder and solvent for solution for injection.
|
instituto Grifols, S.A., Can Guasch, 2. Pol. Ind . levante, 08150 Parets del Vallès, Barcelona Spain - SPAIN
|
2/10/2024 |
| cecolin | Human Papillomavirus Type 16L1 Protien (Recombinant) 40 mcg/0.5ml ; Human Papillomavirus Type 18L1 Protien (Recombinant) 20 mcg/0.5ml |
Suspension for injection in a vial.
|
Xiamen Innovax Biotech Co., Ltd., No. 52, Shanbianhong East Road, Haicang District, Xiamen City, Fujian Province 361027, China
|
2/10/2024 |
| Ultomiris | Ravulizumab |
sterile aqueous solution for intravenous administration
|
Alexion Europe SAS, located at 103-105 rue Anatole France, 92300 Levallois Perret, France.
|
10/9/2024 |
| Optivate |
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
|
Powder and solvent for solution of I.V. injection.
|
Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX - UNITED KINGDOM
|
1/9/2024 |
| Abrilada |
Adalimumab 40 mg/0.8ml
|
Solution for subcutaneous injection in pre-filled syringe or prefilled pen.
|
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, - BELGIUM
|
1/9/2024 |
| nexviazym |
Avalglucosidase alfa 100 mg
|
Powder for concentrate for solution for infusion.
|
Sanofi BV., Paasheuvelweg 25,1105 BP Amsterdam-The Netherlands
|
28/8/2024 |
| Krabeva |
Bevacizumab 25 mg/ml
|
Concentrate For Solution For I.V Infusion
|
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
|
25/8/2024 |
| Esperoct 500 I.U & 1000 |
Turoctocog alfa pegol 500 I.U. and 1000 I.U
|
Powder and Solvent for Solution for I.V. injection
|
Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd- Denmark
|
25/8/2024 |
| enoxaparin USP |
Enoxaparin sodium
|
Solution for subcutaneous injection
|
Nanjing King-Friend Biochemical Pharmaceutical Co. Ltd., No. 16 Xuefu Road, Nanjing High and New Technology Development Zone, Nanjing, Jiangsu 210061 - CHINA
|
25/8/2024 |
| Bexsero |
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.
|
Suspension for injection
|
GSK Vaccines S.r.l., Via Fiorentina 1, 53100 Siena - ITALY
|
7/08/2024 |
| TECAVYLI |
Teclistamab 10 mg/ml
Teclistamab 90 mg/ml
|
Solution for injection
|
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse- Belgium
|
4/08/2024 |
| Vabysmo |
Faricimab
|
solution for Injection
|
Roche Registration GmbH, Emil-Barell-Strasse 1, Grenzach-Wyhlen, 79639 - GERMANY;
|
9/7/2024 |
| Enhertu |
Trastuzumab Deruxtecan 100 mg
|
powder for concentrate for solution for infusion
|
Daiichi Sankyo Europe GmbH , Zielstattstrasse 48, 81379 Munich - GERMANY
|
9/7/2024 |
| Abevmy 100 mg/4ml Abevmy 400 mg/16m |
Bevacizumab 25 mg/ml
|
Concentrate for solution for Infusion
|
Biosimilar collaborations Ireland limited unit 35/36 Grange parade, baldoyle industrial estate, Dublin 13, Ireland D13 R20R.
|
9/7/2024 |
| Skyrizi 150mg |
Risankizumab 150 mg |
Solution for injection
|
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany.
|
18/3/2024 |
| Shingrix vaccine | Varicella Zoster Virus glycoprotein E antigen 50 mcg/0.5ml |
Powder and suspension for suspension for injection |
GlaxoSmithKline Biologicals SA 89, rue de l"Institut, B-1330 Rixensart - BELGIUM
|
18/3/2024 |
| Sarclisa 100&500 MG |
Isatuximab100 mg/5ml Isatuximab 500 mg/25m |
Concentrate for solution for Infusion
|
Sanofi Winthrop Industrie, 82 Avenue Raspail, 94250 Gentillty - France
|
18/3/2024 |
| Pelgraz |
Pegfilgrastim 6mg/0.6ml Solution
|
Solution for injection
|
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex HA1 4HF - United Kingdom
|
18/3/2024 |
| MenQuadfi |
Meningococcal group A, C, W135, Y conjugated to Tetanus Toxoid
|
Solution for injection
|
Sanofi Pasteur Inc., 1 Discovery Drive, Swiftwater, PA 18370 - USA
|
18/3/2024 |
| Herzuma |
Trastuzumab150mg
|
Lypholized Powder and solvent for solution for injection
|
Celltrion, Inc., 20 Academy-ro 51 beon-gil, Yeonsu-gu Incheon, Republic of Korea.
|
18/3/2024 |
| Afstyla |
single chain coagulation factor VIII (rVIII-single chain
|
Powder and solvent for solution for injection
|
CSL Behring GmbH Emil-von-Behring-Straβe 76, D-35041 Marburg-Germany
|
18/3/2024 |