J07
VACCINES
Наименование на групата: WHO Collaborating Centre for Drug Statistics Methodology
Подгрупи
ATC класификацията е дърво. Тази категория се разделя на 3 подгрупи.
Лекарствени продукти в тази категория
93 продукта в тази категория и подгрупите ѝ.
| Търговско име | Концентрация |
|---|---|
| Abrysvo | --¹ After reconstitution, one dose (0.5 mL) contains: RSV subgroup A stabilised prefusion F antigen*,** 60 micrograms RSV subgroup B stabilised prefusion F antigen*,** 60 micrograms * glycoprotein F stabilised in the prefusion conformation ** produced in Chinese Hamster Ovary cells by recombinant DNA technology |
| Adacel | suspension for injection in pre-filled syringe |
| Adacel Polio | suspension for injection in pre-filled syringe |
| Adjupanrix | --¹ After mixing, 1 dose (0.5 ml) contains: Split influenza virus, inactivated, containing antigen* equivalent to: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) 3.75 μg** * propagated in eggs ** haemagglutinin AS03 adjuvant composed of squalene (10.69 mg), DL-alfa-tocopherol (11.86 mg) and polysorbate 80 (4.86 mg) |
| Aflunov | --¹ Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/turkey/Turkey/1/2005 (H5N1) - like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** expressed in microgram haemagglutinin Adjuvant MF59C.1 containing: squalene 9.75 milligrams polysorbate 80 1.175 milligrams sorbitan trioleate 1.175 milligrams sodium citrate 0.66 milligrams citric acid 0.04 milligrams |
| Ambirix | --¹ 1 dose (1 ml) contains: Hepatitis A virus (inactivated)¹,² 720 ELISA Units Hepatitis B surface antigen³,⁴ 20 micrograms ¹Produced on human diploid (MRC-5) cells ²Adsorbed on aluminium hydroxide, hydrated 0.05 milligrams Al³+ ³Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology ⁴Adsorbed on aluminium phosphate 0.4 milligrams Al³+ |
| Anti - CHF Vaccine | suspension for injection. |
| AREXVY | --¹ After reconstitution, one dose (0.5 mL) contains: RSVPreF3¹ antigen²,³ 120 micrograms ¹ Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation = RSVPreF3 ² RSVPreF3 produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology ³ adjuvanted with AS01E containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 25 micrograms 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota 25 micrograms |
| Avaxim 160U adult | 0,5 ml |
| Avaxim 80U Pediatric | 0,5 ml |
| BCG Vaccine | 0.05 mg |
| Bexsero | --¹ One dose (0.5 ml) contains: Recombinant Neisseria meningitidis group B NHBA fusion protein ¹, ², ³ 50 micrograms Recombinant Neisseria meningitidis group B NadA protein ¹, ², ³ 50 micrograms Recombinant Neisseria meningitidis group B fHbp fusion protein ¹, ², ³ 50 micrograms Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4² 25 micrograms ¹ produced in E. coli cells by recombinant DNA technology ² adsorbed on aluminium hydroxide (0.5 mg Al³+) ³ NHBA (Neisseria Heparin Binding Antigen), NadA (Neisserial adhesin A), fHbp (factor H binding protein) |
| BIMERVAX | --¹ One dose (0.5 mL) contains: 40 micrograms of selvacovatein adjuvanted with SQBA (EU/1/22/1709/001-004). Selvacovatein is a SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer (B.1.351 and B.1.1.7 strains) produced by recombinant DNA technology using a plasmid expression vector in a CHO cell line. SQBA adjuvant containing per 0.5 mL dose: squalene (9.75 mg), polysorbate 80 (1.18 mg), sorbitan trioleate (1.18 mg), sodium citrate (0.66 mg), citric acid (0.04 mg) and water for injections. |
| Boostrix | suspension for injection in pre-filled syringe |
| Boostrix Polio | suspension for injection in pre-filled syringe |
| CAPVAXIVE | --¹ 1 dose (0.5ml) contains: Pneumococcal polysaccharide serotype 3¹ 4 μg Pneumococcal polysaccharide serotype 6A¹ 4 μg Pneumococcal polysaccharide serotype 7F¹ 4 μg Pneumococcal polysaccharide serotype 8¹ 4 μg Pneumococcal polysaccharide serotype 9N¹ 4 μg Pneumococcal polysaccharide serotype 10A¹ 4 μg Pneumococcal polysaccharide serotype 11A¹ 4 μg Pneumococcal polysaccharide serotype 12F¹ 4 μg Pneumococcal polysaccharide serotype 15A¹ 4 μg Pneumococcal polysaccharide from deOAc15B (de-O-acetylated serotype 15B¹) 4 μg Pneumococcal polysaccharide serotype 16F¹ 4 μg Pneumococcal polysaccharide serotype 17F¹ 4 μg Pneumococcal polysaccharide serotype 19A¹ 4 μg Pneumococcal polysaccharide serotype 20A¹ 4 μg Pneumococcal polysaccharide serotype 22F¹ 4 μg Pneumococcal polysaccharide serotype 23A¹ 4 μg Pneumococcal polysaccharide serotype 23B¹ 4 μg Pneumococcal polysaccharide serotype 24F¹ 4 μg Pneumococcal polysaccharide serotype 31¹ 4 μg Pneumococcal polysaccharide serotype 33F¹ 4 μg Pneumococcal polysaccharide serotype 35B¹ 4 μg ¹Conjugated to CRM197 carrier protein. CRM197 is a nontoxic mutant of diphtheria toxin (originating from Corynebacterium diphtheriae C7) expressed recombinantly in Pseudomonas fluorescens. 1 dose (0.5 mL) contains approximately 65 μg CRM197 carrier protein. |
| Celldemic | --¹ One dose (0.5 ml) contains: Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of strain*: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) 7.5 micrograms** * propagated in Madin Darby Canine Kidney (MDCK) cells ** expressed in micrograms haemagglutinin. Adjuvant MF59C.1 containing: squalene 9.75 milligrams polysorbate 80 1.175 milligrams sorbitan trioleate 1.175 milligrams sodium citrate 0.66 milligrams citric acid 0.04 milligrams |
| Cervarix | --¹ 1 dose (0.5 ml) contains: Human Papillomavirus1 type 16 L1 protein²,³,⁴ 20 micrograms Human Papillomavirus1 type 18 L1 protein²,³,⁴ 20 micrograms 1Human Papillomavirus = HPV ²adjuvanted by AS04 containing: 3-O-desacyl-4’- monophosphoryl lipid A (MPL)³ 50 micrograms ³ adsorbed on aluminium hydroxide, hydrated (Al(OH)₃) 0.5 milligrams Al³+ in total ⁴L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni. |
| COMIRNATY | -¹⁵ COMIRNATY JN.1 30 micrograms/dose dispersion for injection (EU/1/20/1528/028-031, EU/1/20/1528/043): 1 dose (0.3 mL) contains 30 micrograms of bretovameran, COVID-19 mRNA Vaccine (nucleoside modified, embedded in lipid nanoparticles). Bretovameran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (Omicron JN.1). |
| Diftet | suspension for injection |
| Dukoral | --¹ Each dose of vaccine suspension (3 ml) contains: - A total of 1.25x10¹¹ bacteria of the following strains: Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 31.25x10⁹ bacteria Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 31.25x10⁹ bacteria Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 31.25x10⁹ bacteria Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x10⁹ bacteria - Recombinant cholera toxin B subunit (rCTB) 1 mg |
| Efluelda | Efluelda suspеnsion for injection in pre-filled syringe |
| Efluelda Tetra | suspеnsion for injection in pre-filled syringe |
| Engerix В | 0,5 ml |
| Engerix В | 1 ml |
| Ervebo | --¹ One dose (1 mL) contains: Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP¹² live, attenuated) ≥72 million pfu³ ¹Recombinant Vesicular Stomatitis Virus (rVSV) strain Indiana with a deletion of the VSV envelope glycoprotein (G) replaced with the Zaire Ebola Virus (ZEBOV) Kikwit 1995 strain surface glycoprotein (GP) ²Produced in Vero cells ³pfu= plaque-forming units |
| Fendrix | --¹ 1 dose (0.5 ml) contains: Hepatitis B surface antigen¹,²,³ 20 micrograms ¹adjuvanted by AS04C containing: - 3-O-desacyl-4’- monophosphoryl lipid A (MPL)² 50 micrograms ²adsorbed on aluminium phosphate (0.5 milligrams Al³+ in total) ³produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology |
| Fluad | --¹ Each 0.5 ml dose contains: Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*: A/Missouri/11/2025 (H1N1)pdm09-like strain (A/Missouri/11/2025, IVR-279) 15 micrograms HA** A/Darwin/1454/2025 (H3N2)-like strain (A/Michigan/105/2025, IVR-285) 15 micrograms HA** B/Tokyo/EIS13-175/2025-like strain (B/Tokyo/EIS13-175/2025, wild type) 15 micrograms HA** *propagated in fertilised hens’ eggs from healthy chicken flocks and adjuvanted with MF59C.1 **haemagglutinin |
| Fluarix | — |
| Fluarix Tetra | suspension for injection in pre-filled syringe |
| Flucelvax | --¹ Each 0.5 ml dose contains: Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*: A/Missouri/11/2025 (H1N1)pdm09-like strain (A/Tasmania/318/2025, CVR-351) 15 micrograms HA** A/Darwin/1415/2025 (H3N2)-like strain (A/Tasmania/787/2025, CVR-388) 15 micrograms HA** B/Pennsylvania/14/2025-like strain (B/Arizona/21/2025, wild type) 15 micrograms HA** * propagated in Madin Darby Canine Kidney (MDCK) cells ** haemagglutinin |
| Fluenz | --¹ 1 dose (0.2 ml) contains: Reassortant influenza virus* (live attenuated) of the following three strains**: A/Missouri/11/2025 (H1N1) pdm09-like strain (A/Switzerland/6849/2025, MEDI 400592) 10⁷.⁰±⁰.⁵ FFU*** A/Darwin/1454/2025 (H3N2)-like strain (A/Darwin/1369/2025, MEDI 406666) 10⁷.⁰±⁰.⁵ FFU*** B/Tokyo/EIS13-175/2025-like strain (B/Perth/115/2025, MEDI 407730) 10⁷.⁰±⁰.⁵ FFU*** * Propagated in fertilised hens’ eggs from healthy chicken flocks. ** Produced in VERO cells by reverse genetic technology. This product contains genetically modified organisms (GMOs). *** Fluorescent Focus Units. |
| Foclivia | 15 µg/ml |
| Gardasil | --¹ 1 dose (0.5 ml) contains approximately: Human Papillomavirus¹ Type 6 L1 protein², ³ 20 µg Human Papillomavirus¹ Type 11 L1 protein², ³ 40 µg Human Papillomavirus¹ Type 16 L1 protein², ³ 40 µg Human Papillomavirus¹ Type 18 L1 protein², ³ 20 µg ¹ Human Papillomavirus = HPV ² L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology ³ adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (225 micrograms Al) |
| Gardasil 9 | --¹ 1 dose (0.5 ml) contains approximately: Human Papillomavirus¹ Type 6 L1 protein²,³ 30 micrograms Human Papillomavirus¹ Type 11 L1 protein²,³ 40 micrograms Human Papillomavirus¹ Type 16 L1 protein²,³ 60 micrograms Human Papillomavirus¹ Type 18 L1 protein²,³ 40 micrograms Human Papillomavirus¹ Type 31 L1 protein²,³ 20 micrograms Human Papillomavirus¹ Type 33 L1 protein²,³ 20 micrograms Human Papillomavirus¹ Type 45 L1 protein²,³ 20 micrograms Human Papillomavirus¹ Type 52 L1 protein²,³ 20 micrograms Human Papillomavirus¹ Type 58 L1 protein²,³ 20 micrograms ¹ Human Papillomavirus = HPV ² L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology ³ adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.5 milligrams Al) |
| Havrix 1440 | suspension for injection (adult dose) |
| Havrix 720 | suspension for injection (junior monodose) |
| HBVAXPRO | 5 µg/0.5 ml |
| HEPLISAV B | --¹ One dose (0.5 mL) contains: Hepatitis B surface antigen¹,² 20 µg ¹Adjuvanted with 3000 micrograms 1018 adjuvant, a 22-mer immunostimulatory sequence oligonucleotide ²Produced in Hansenula polymorpha yeast cells by recombinant DNA technology |
| Hexacima | --¹ One dose¹ (0.5 ml) contains: Diphtheria Toxoid not less than 20 IU (30 Lf) Tetanus Toxoid not less than 40 IU (10 Lf) Bordetella pertussis antigens Pertussis Toxoid 25 micrograms Filamentous Haemagglutinin 25 micrograms Poliovirus (Inactivated) Type 1 (Mahoney) 29 D-antigen units Type 2 (MEF-1) 7 D-antigen units Type 3 (Saukett) 26 D-antigen units Hepatitis B surface antigen 10 micrograms Haemophilus influenzae type b polysaccharide 12 micrograms (Polyribosylribitol Phosphate) conjugated to Tetanus protein 22-36 micrograms ¹ Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al³⁺) |
| Hexyon | --¹ One dose¹ (0.5 ml) contains: Diphtheria Toxoid not less than 20 IU (30 Lf) Tetanus Toxoid not less than 40 IU (10 Lf) Bordetella pertussis antigens Pertussis Toxoid 25 micrograms Filamentous Haemagglutinin 25 micrograms Poliovirus (Inactivated) Type 1 (Mahoney) 29 D-antigen units Type 2 (MEF-1) 7 D-antigen units Type 3 (Saukett) 26 D-antigen units Hepatitis B surface antigen 10 micrograms Haemophilus influenzae type b polysaccharide 12 micrograms (Polyribosylribitol Phosphate) conjugated to Tetanus protein 22-36 micrograms ¹ Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al³⁺) |
| IMVANEX | --¹ Virus titer no less than of 5 x 10⁷ Inf.U One dose (0.5 ml) contains: Modified Vaccinia Ankara – Bavarian Nordic Live virus no less than 5 x 10⁷ Inf.U * *infectious units Produced in chick embryo cells |
| Incellipan | --¹ One dose (0.5 ml) contains: Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of strain*: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) 7.5 micrograms** * propagated in Madin Darby Canine Kidney (MDCK) cells ** expressed in micrograms haemagglutinin. Adjuvant MF59C.1 containing: squalene 9.75 milligrams polysorbate 80 1.175 milligrams sorbitan trioleate 1.175 milligrams sodium citrate 0.66 milligrams citric acid 0.04 milligrams |
| Infanrix hexa | --¹ After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid, adsorbed ≥ 30 IU Tetanus toxoid, adsorbed ≥ 40 IU Pertussis toxoid, adsorbed 25 µg Filamentous haemagglutinin, adsorbed 25 µg Pertactin, adsorbed 8 µg Recombinant hepatitis B surface antigen (S protein), adsorbed 10 µg Inactivated type 1 poliovirus 40 DU Inactivated type 2 poliovirus 8 DU Inactivated type 3 poliovirus 32 DU Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP) 10 µg and tetanus toxoid (T), adsorbed (PRP-T) approximately 25 µg |
| Infanrix-IPV+Hib | powder and suspension for suspension for injection |
| Influvac | Influvac suspension for injection in pre-filled syringe |
| Influvac Tetra | suspension for injection in pre-filled syringe |
| IXCHIQ | --¹ After reconstitution, one dose (0.5 ml) contains: Chikungunya virus (CHIKV) Δ5nsP3 strain (live, attenuated)* not less than 3.0 log₁₀ TCID₅₀** *Produced in Vero cells ** 50% tissue culture infectious dose |
| Ixiaro | --¹ 1 dose (0.5 ml) contains: Japanese encephalitis virus strain SA₁₄-14-2 (inactivated)¹-² 6 AU³ corresponding to a potency of ≤ 460 ng ED₅₀ ¹ produced in Vero cells ² adsorbed on aluminium hydroxide, hydrated (approximately 0.25 milligrams Al³+) ³ Antigen Units |
| Kostaive | --¹ After reconstitution with 10 mL of sterile 0.9% Sodium Chloride Injection, one dose (0.5 mL) contains 5 micrograms of Zapomeran, a COVID-19 mRNA (encapsulated in lipid nanoparticles). Zapomeran is a single-stranded, 5'-capped messenger RNA (mRNA) replicon (self-amplifying mRNA), produced using a cell-free in vitro transcription from the corresponding DNA templates encoding a replicase and the spike glycoprotein of the G clade D614G variant of SARS-CoV-2. |
| mCOMBRIAX | --¹ One dose (0.32 mL) contains 31.7 micrograms of total RNA. mCOMBRIAX is single stranded, 5’-capped messenger RNAs (mRNAs) produced using a cell-free in vitro transcription from the corresponding DNA template, encoding seasonal influenza haemagglutinin (HA) glycoproteins: A/H1N1, A/H3N2, B/Victoria, and the linked N terminal domain and receptor-binding domain of the viral spike (S) protein of SARS CoV 2. Influenza virus strains and SARS CoV 2 composition per 0.32 mL dose: A/Wisconsin/67/2022 (A/H1N1 pdm09) .................…………………............8.3 micrograms RNA A/Darwin/6/2021 (A/H3N2) ..................................………………..............8.3 micrograms RNA B/Austria/1359417/2021 (B/Victoria lineage) ......................................8.3 micrograms RNA SARS CoV 2 Omicron XBB.1.5 ...........................................................6.7 micrograms RNA |
| MenQuadfi | --¹ One dose 0.5 mL contains: Neisseria meningitidis group A polysaccharide² 10 micrograms Neisseria meningitidis group C polysaccharide² 10 micrograms Neisseria meningitidis group Y polysaccharide² 10 micrograms Neisseria meningitidis group W polysaccharide² 10 micrograms ²Conjugated to tetanus toxoid carrier protein 55 micrograms |
| Menveo | --¹ One dose (0.5 ml) contains: Meningococcal group A oligosaccharide 10 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 16.7 to 33.3 micrograms Meningococcal group C oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 7.1 to 12.5 micrograms Meningococcal group W135 oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 3.3 to 8.3 micrograms Meningococcal group Y oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM197 protein 5.6 to 10.0 micrograms |
| M-M-RvaxPro | --¹ After reconstitution, one dose (0.5 ml) contains: Measles virus**¹ Enders' Edmonston strain (live, attenuated) not less than 1x10³ CCID50* Mumps virus**¹ Jeryl Lynn™ [Level B] strain (live, attenuated) not less than 12.5x10³ CCID50* Rubella virus**² Wistar RA 27/3 strain (live, attenuated) not less than 1x10³ CCID50* *50% tissue culture infectious dose **¹ Produced in chick embryo cells. **² Produced in WI-38 human diploid lung fibroblasts. |
| mNEXSPIKE | --¹ One dose (0.2 mL) contains 10 micrograms of SARS-CoV-2 mRNA. mNEXSPIKE is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA template, encoding the N-terminal domain and receptor-binding domain of the viral spike (S) protein of SARS-CoV-2 (XBB.1.5). |
| mRESVIA | --¹ One dose (0.5 mL) contains 50 micrograms of RSV mRNA (nucleoside modified) encapsulated in lipid nanoparticles. |
| Nimenrix | --¹ Neisseria meningitidis serogroup A polysaccharide* 5 micrograms Neisseria meningitidis serogroup C polysaccharide* 5 micrograms Neisseria meningitidis serogroup W-135 polysaccharide* 5 micrograms Neisseria meningitidis serogroup Y polysaccharide* 5 micrograms *conjugated to tetanus toxoid carrier protein 44 micrograms |
| Nuvaxovid | --¹ One dose (0.5 ml) contains 5 µg of the of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M. Adjuvant Matrix-M containing per 0.5 mL dose: Fraction-A (42.5 µg) and Fraction-C (7.5 µg) of Quillaja saponaria Molina extract. * produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species. |
| Pandemic influenza vaccine H5N1 AstraZeneca | --¹ 1 dose (0.2 ml) contains: Reassortant influenza virus* (live attenuated) of the following strain***: A/Vietnam/1203/2004 (H5N1) strain (A/Vietnam/1203/2004, MEDI 0141000136) 10⁷.⁰±⁰.⁵ FFU** * propagated in fertilised hens’ eggs from healthy chicken flocks. ** produced in VERO cells by reverse genetic technology. This product contains a genetically modified organism (GMO). *** fluorescent focus units |
| Pentaxim | powdеr and suspension for suspension for injection |
| Pneumovax 23 | solution for injection in pre-filled syringe |
| Prevenar 13 | --¹ 1 dose (0.5 ml) contains: Pneumococcal polysaccharide serotype 1¹ 2.2 µg Pneumococcal polysaccharide serotype 3¹ 2.2 µg Pneumococcal polysaccharide serotype 4¹ 2.2 µg Pneumococcal polysaccharide serotype 5¹ 2.2 µg Pneumococcal polysaccharide serotype 6A¹ 2.2 µg Pneumococcal polysaccharide serotype 6B¹ 4.4 µg Pneumococcal polysaccharide serotype 7F¹ 2.2 µg Pneumococcal polysaccharide serotype 9V¹ 2.2 µg Pneumococcal polysaccharide serotype 14¹ 2.2 µg Pneumococcal polysaccharide serotype 18C¹ 2.2 µg Pneumococcal polysaccharide serotype 19A¹ 2.2 µg Pneumococcal polysaccharide serotype 19F¹ 2.2 µg Pneumococcal polysaccharide serotype 23F¹ 2.2 µg ¹ Conjugated to CRM₁₉₇ carrier protein, adsorbed on aluminium phosphate. 1 dose contains approximately 32 µg CRM₁₉₇ carrier protein and 0.125 mg aluminium. |
| Prevenar 20 | --¹ 1 dose (0.5 mL) contains: Pneumococcal polysaccharide serotype 1¹ ² 2.2 μg Pneumococcal polysaccharide serotype 3¹ ² 2.2 μg Pneumococcal polysaccharide serotype 4¹ ² 2.2 μg Pneumococcal polysaccharide serotype 5¹ ² 2.2 μg Pneumococcal polysaccharide serotype 6A¹ ² 2.2 μg Pneumococcal polysaccharide serotype 6B¹ ² 4.4 μg Pneumococcal polysaccharide serotype 7F¹ ² 2.2 μg Pneumococcal polysaccharide serotype 8¹ ² 2.2 μg Pneumococcal polysaccharide serotype 9V¹ ² 2.2 μg Pneumococcal polysaccharide serotype 10A¹ ² 2.2 μg Pneumococcal polysaccharide serotype 11A¹ ² 2.2 μg Pneumococcal polysaccharide serotype 12F¹ ² 2.2 μg Pneumococcal polysaccharide serotype 14¹ ² 2.2 μg Pneumococcal polysaccharide serotype 15B¹ ² 2.2 μg Pneumococcal polysaccharide serotype 18C¹ ² 2.2 μg Pneumococcal polysaccharide serotype 19A¹ ² 2.2 μg Pneumococcal polysaccharide serotype 19F¹ ² 2.2 μg Pneumococcal polysaccharide serotype 22F¹ ² 2.2 μg Pneumococcal polysaccharide serotype 23F¹ ² 2.2 μg Pneumococcal polysaccharide serotype 33F¹ ² 2.2 μg ¹ Conjugated to CRM₁₉₇ carrier protein (approximately 51 μg per dose) ² Adsorbed on aluminium phosphate (0.125 mg aluminium per dose) |
| Priorix | powder and solvent for solution for injection |
| Priorix-Tetra | powder and solvent for solution for injection |
| ProQuad | --¹ After reconstitution, one dose (0.5 ml) contains: Measles virus¹ Enders’ Edmonston strain (live, attenuated) not less than 3.00 log10 CCID50* Mumps virus¹ Jeryl Lynn™ (Level B) strain (live, attenuated) not less than 4.30 log10 CCID50* Rubella virus² Wistar RA 27/3 strain (live, attenuated) not less than 3.00 log10 CCID50* Varicella virus³ Oka/Merck strain (live, attenuated) not less than 3.99 log10 PFU** *50% cell culture infectious dose **plaque-forming units ¹ Produced in chick embryo cells. ² Produced in human diploid lung (WI-38) fibroblasts. ³ Produced in human diploid (MRC-5) cells. |
| Qdenga | --¹ After reconstitution, 1 dose (0.5 mL) contains: Dengue virus serotype 1 (live, attenuated)*: ≥ 3.3 log10 PFU**/dose Dengue virus serotype 2 (live, attenuated)#: ≥ 2.7 log10 PFU**/dose Dengue virus serotype 3 (live, attenuated)*: ≥ 4.0 log10 PFU**/dose Dengue virus serotype 4 (live, attenuated)*: ≥ 4.5 log10 PFU**/dose *Produced in Vero cells by recombinant DNA technology. Genes of serotype-specific surface proteins engineered into dengue type 2 backbone #Produced in Vero cells by recombinant DNA technology **PFU = Plaque-forming units |
| Rabipur | — |
| Rabipur | — |
| Rotarix | --¹ not less than 10⁶·⁰ CCID₅₀ |
| RotaTeq | --¹ One dose (2 ml) contains: Rotavirus type* G1 not less than 2.2 x 10⁶ IU¹, ² Rotavirus type* G2 not less than 2.8 x 10⁶ IU¹, ² Rotavirus type* G3 not less than 2.2 x 10⁶ IU¹, ² Rotavirus type* G4 not less than 2.0 x 10⁶ IU¹, ² Rotavirus type* P1A[8] not less than 2.3 x 10⁶ IU¹, ² * Human-bovine rotavirus reassortants (live), produced in Vero cells. ¹ Infectious Units ² As lower confidence limit (p = 0.95) |
| Shingrix | --¹ After reconstitution, one dose (0.5 mL) contains: Varicella Zoster Virus¹ glycoprotein E antigen²,³ 50 micrograms ¹ Varicella Zoster Virus = VZV ² adjuvanted with AS01B containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 50 micrograms 3-O-desacyl-4’-monophosphoryl lipid A (MPL) from Salmonella minnesota 50 micrograms ³ glycoprotein E (gE) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology |
| Spikevax | --⁶ One dose (0.5 mL) contains 50 micrograms of SARS-CoV-2 JN.1 mRNA, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles). One dose (0.25 mL) contains 25 micrograms of SARS-CoV-2 JN.1 mRNA, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in lipid nanoparticles). SARS-CoV-2 JN.1 mRNA is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (JN.1). |
| Stamaril | powder and solvent for suspension for injection |
| Supemtek | --¹ One dose (0.5 ml) contains: Influenza virus haemagglutinin (HA) proteins, of the following strains*: A/California/07/2009 (H1N1)pdm09-like strain (A/California/07/2009) 45 micrograms HA A/Texas/50/2012 (H3N2)-like strain (A/Texas/50/2012) 45 micrograms HA B/Brisbane/60/2008-like strain (B/Brisbane/60/2008) 45 micrograms HA * produced by recombinant DNA technology using a baculovirus expression system in a continuous insect cell line that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda. |
| Supemtek Tetra | --¹ One dose (0.5 mL) contains: Influenza virus haemagglutinin (HA) proteins, of the following strains*: A/XXXXXX (H1N1).................................. 45 micrograms HA A/XXXXXX (H3N2).................................. 45 micrograms HA B/XXXXXX............................................... 45 micrograms HA B/XXXXXX............................................... 45 micrograms HA * produced by recombinant DNA technology using a baculovirus expression system in a continuous insect cell line that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda. |
| Synflorix | --¹ 1 dose (0.5 ml) contains: Pneumococcal polysaccharide serotype 1* ¹ 1 microgram Pneumococcal polysaccharide serotype 4* ¹ 3 micrograms Pneumococcal polysaccharide serotype 5* ¹ 1 microgram Pneumococcal polysaccharide serotype 6B* ¹ 1 microgram Pneumococcal polysaccharide serotype 7F* ¹ 1 microgram Pneumococcal polysaccharide serotype 9V* ¹ 1 microgram Pneumococcal polysaccharide serotype 14* ¹ 1 microgram Pneumococcal polysaccharide serotype 18C* ² 3 micrograms Pneumococcal polysaccharide serotype 19F* ³ 3 micrograms Pneumococcal polysaccharide serotype 23F* ¹ 1 microgram * adsorbed on aluminium phosphate 0.5 milligram Al³+ ¹ conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein 9-16 micrograms ² conjugated to tetanus toxoid carrier protein 5-10 micrograms ³ conjugated to diphtheria toxoid carrier protein 3- 6 micrograms |
| Tetadif | suspension for injection |
| Tetatox | suspension for injection |
| Tetraxim | 0,5 ml |
| Trumenba | --¹ 1 dose (0.5 ml) contains: Neisseria meningitidis serogroup B fHbp subfamily A¹,²,³ 60 micrograms Neisseria meningitidis serogroup B fHbp subfamily B¹,²,³ 60 micrograms ¹ Recombinant lipidated fHbp (factor H binding protein) ² Produced in Escherichia coli cells by recombinant DNA technology ³ Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose) |
| Twinrix Adult | 1 dose (1 ml) contains: Hepatitis A virus (inactivated)¹,² 720 ELISA Units Hepatitis B surface antigen³,4 20 micrograms ¹Produced on human diploid (MRC-5) cells ²Adsorbed on aluminium hydroxide, hydrated 0.05 milligrams Al³+ ³Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate 0.4 milligrams Al³+ |
| Twinrix Paediatric | --¹ 1 dose (0.5 ml): Hepatitis A virus (inactivated)¹,² 360 ELISA Units Hepatitis B surface antigen³,⁴ 10 micrograms ¹Produced on human diploid (MRC-5) cells ²Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al³+ ³Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology ⁴Adsorbed on aluminium phosphate 0.2 milligrams Al³+ |
| Typhim VI | 0,5 ml |
| VacPertagen | --¹ One dose (0.5 ml) contains: Purified Bordetella pertussis antigens Recombinant Pertussis Toxin (PTgen )¹,² 5 micrograms Filamentous Haemagglutinin (FHA)¹ 5 micrograms ¹adsorbed on aluminum hydroxide, hydrated 0.3 milligrams Al³⁺ ²produced in Bordetella pertussis as a genetically detoxified PT (PTgen or rPT) by recombinant DNA technology Formaldehyde may be present in trace amounts as a manufacturing process residual. |
| Varivax | powder and solvent for suspension for injection in pre-filled syringe |
| Vaxchora | --¹ ¹One dose contains: Not less than 4 x 10E8 viable cells of Vibrio cholerae live, attenuated strain CVD 103-HgR |
| Vaxelis | --¹ One dose (0.5 ml) contains: Diphtheria Toxoid¹: 15 Lf (≥ 20 IU)⁶ Tetanus Toxoid¹: 5 Lf (≥ 40 IU)⁶ Bordetella pertussis antigens¹: Pertussis Toxoid (PT) 20 micrograms Filamentous Haemagglutinin (FHA) 20 micrograms Pertactin (PRN) 3 micrograms Fimbriae Types 2 and 3 (FIM) 5 micrograms Hepatitis B surface antigen²,³: 10 micrograms Poliovirus (Inactivated)⁴: Type 1 (Mahoney) 29 D antigen units⁵ Type 2 (MEF-1) 7 D antigen units⁵ Type 3 (Saukett) 26 D antigen units⁵ Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) 3 micrograms Conjugated to meningococcal protein² 50 micrograms ¹ adsorbed on aluminium phosphate (0.17 mg Al³⁺) ² adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al³⁺) ³ produced in yeast (Saccharomyces cerevisiae) cells by recombinant DNA technology ⁴ produced in Vero cells ⁵ These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method ⁶ or equivalent activity determined by an immunogenicity or antigenicity evaluation. |
| Vaxigrip | Vaxigrip suspеnsion for injection in pre-filled syringe |
| Vaxigrip Tetra | suspеnsion for injection in pre-filled syringe |
| Vaxneuvance | --¹ One dose (0.5 mL) contains: Pneumococcal polysaccharide serotype 1¹,² 2.0 µg Pneumococcal polysaccharide serotype 3¹,² 2.0 µg Pneumococcal polysaccharide serotype 4¹,² 2.0 µg Pneumococcal polysaccharide serotype 5¹,² 2.0 µg Pneumococcal polysaccharide serotype 6A¹,² 2.0 µg Pneumococcal polysaccharide serotype 6B¹,² 4.0 µg Pneumococcal polysaccharide serotype 7F¹,² 2.0 µg Pneumococcal polysaccharide serotype 9V¹,² 2.0 µg Pneumococcal polysaccharide serotype 14¹,² 2.0 µg Pneumococcal polysaccharide serotype 18C¹,² 2.0 µg Pneumococcal polysaccharide serotype 19A¹,² 2.0 µg Pneumococcal polysaccharide serotype 19F¹,² 2.0 µg Pneumococcal polysaccharide serotype 22F¹,² 2.0 µg Pneumococcal polysaccharide serotype 23F¹,² 2.0 µg Pneumococcal polysaccharide serotype 33F¹,² 2.0 µg ¹ Conjugated to CRM₁₉₇ carrier protein. CRM₁₉₇ is a nontoxic mutant of diphtheria toxin (originating from Corynebacterium diphtheriae C7) expressed recombinantly in Pseudomonas fluorescens. ² Adsorbed on aluminium phosphate adjuvant. |
| Verorab | powder and solvent for suspension for injection |
| Zoonotic Influenza Vaccine Seqirus | --¹ Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain: A/Astrakhan/3212/2020 (H5N8) - like strain (CBER-RG8A) (clade 2.3.4.4b) 7.5 micrograms** per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** expressed in microgram haemagglutinin Adjuvant MF59C.1 containing: squalene 9.75 milligrams polysorbate 80 1.175 milligrams sorbitan trioleate 1.175 milligrams sodium citrate 0.66 milligrams citric acid 0.04 milligrams |