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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100038-PIP01-21-M01 (update)
  • SARS CoV2 prefusion Spike delta TM (CoV2 preS dTM) protein, recombinant adjuvanted with AS03
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vidprevtyn
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 17/05/2022
MHRA-100237-PIP01-21-M01 (update)
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Victoria lineage)
  • Split influenza virus, inactivated containing antigens equivalent to the B-like strain (Yamagata lineage)
  • Prevention of influenza infection
  • Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain
  • Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (called Efluelda throughout rest of Europe)
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Efluelda
  • Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High Dose
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 29/07/2022
MHRA-100197-PIP01-21-M01 (update)
  • Ebola Zaire Vaccine (rVSV∆G-ZEBOV-GP, live)
  • Prevention of Ebola disease
  • ERVEBO
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 27/09/2022
MHRA-100149-PIP01-21-M01 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid (Please note that details provided herein specifically relate to Singapore)
  • Nuvaxovid
  • Nuvaxovid (Please note that details provided herein specifically relate to Singapore)
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • Nuvaxovid
  • TBD - Approval not yet granted
  • TBD - Approval not yet granted
  • Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100490-PIP01-22-M01 (update)
  • nirsevimab (MEDI8897)
  • Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).
  • Beyfortus
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 27/09/2022
MHRA-100177-PIP01-21-M01 (update)
  • INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN
  • INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN
  • Prevention of influenza
  • FLUCELVAX TETRA
  • FLUCELVAX TETRA
  • FLUCELVAX QUADRIVALENT
  • FLUCELVAX QUAD
  • FLUCELVAX QUAD
  • FLUCELVAX QUAD
  • FLUCELVAX QUAD
  • FLUCELVAX TETRA
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 21/10/2022
MHRA-100236-PIP01-21-M01 (update)
  • Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Disease caused by Streptococcus pneumoniae
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/11/2022
MHRA-100236-PIP01-21-M02 (update)
  • Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Prevention of disease caused by Streptococcus pneumoniae
  • Prevnar 20
  • Apexxnar
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 10/11/2022
MHRA-100408-PIP01-21-M01 (update)
  • Hepatitis B (rDNA) surface antigen adjuvanted
  • Prevention of hepatitis B virus infection
  • HEPLISAV B
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100502-PIP01-22-M01 (update)
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (Victoria lineage)
  • Recombinant Influenza Hemagglutinin-strain B (Yamagata lineage)
  • Prevention of influenza infection
  • Supemtek
  • Supemtek
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes 07/12/2022
MHRA-100557-PIP01-22-M01 (update)
  • Hepatitis B (rDNA) surface antigen adjuvanted
  • Prevention of hepatitis B virus infection
  • HEPLISAV B
  • HEPLISAV-B
  • HEPLISAV-B
  • HEPLISAV B
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100600-PIP01-22-M01 (update)
  • Modified Vaccinia Ankara - Bavarian Nordic virus (smallpox)
  • Prevention of smallpox, monkeypox, related orthopoxvirus infection and disease
  • Imvanex
  • Imvamune
  • Jynneos
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 07/12/2022
MHRA-100701-PIP01-22-M01 (update)
  • Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254
  • Recombinant Neisseria meningitis group B Protein 936-741
  • Meningococcal group W-135 oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Meningococcal group A oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Meningococcal group C oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Recombinant Neisseria meningitis group B Protein 287- 953
  • Recombinant Neisseria meningitis group B Protein 961c
  • Meningococcal group Y oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Prevention of meningococcal meningitis
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100475-PIP01-22-M01 (update)
  • Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid
  • Neisseria meningitidis serogroup W polysaccharide conjugated to tetanus toxoid
  • Prevention of invasive meningococcal disease
  • MenQuadfi
  • MenQuadfi
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 30/06/2023
MHRA-100177-PIP01-21-M02 (update)
  • INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN
  • INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN
  • INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN
  • INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN
  • Prevention of Influenza
  • FLUCELVAX TETRA
  • Cell-based Quadrivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe
  • FLUCELVAX TETRA
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 24/08/2023
MHRA-100601-PIP01-22-M02 (update)
  • elasomeran
  • imelasomeran
  • DAVESOMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Spikevax
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.1
  • Spikevax bivalent Original/Omicron BA.4-5
  • Spikevax bivalent Original/Omicron BA.4-5
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100149-PIP01-21-M02 (update)
  • NVX-CoV2373
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Approved invented name: Nuvaxovid dispersion for injection, Covid-19 Vaccine (recombinant, adjuvanted)
  • Nuvaxovid
  • Nuvaxovid (Note: PLGB registration, applicable to Great Britain only)
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100236-PIP01-21-M03 (update)
  • Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 14 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 23F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 5 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 6B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 19F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 15B conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 1 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 4 conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 9V conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Pneumococcal Polysaccharide Serotype 18C conjugated to CRM197 carrier protein and adsorbed on aluminium Phosphate
  • Prevention of disease caused by Streptococcus pneumoniae
  • Apexxnar
  • Prevnar 20
  • Apexxnar
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted 19/12/2023
MHRA-100470-PIP01-22-M01 (update)
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis serogroup B fHbp subfamily A Neisseria meningitidis serogroup B fHbp subfamily B Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
  • Prevention of Invasive disease caused by Neisseria meningitidis group A, B, C, W and Y
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
MHRA-100473-PIP01-22-M01 (update)
  • Recombinant COVID-19 subunit nanoparticle
  • Prevention of coronavirus disease 2019 (COVID-19)
  • SKYCovion
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No 19/12/2023
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