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PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-102318-PIP01-26
  • Taletrectinib adipate
  • Treatment of non-small cell lung cancer
  • Not available at present
  • DOVBLERON
  • IBTROZI
  • IBTROZI
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102197-PIP01-25
  • DIFLUNISAL
  • Treatment of transthyretin amyloidosis
  • Attrogy
  • Attrogy
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100212-PIP01-21-M04 (update)
  • FINERENONE
  • Treatment of chronic kidney disease.
  • Kerendia
  • Uro-Nephrology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100951-PIP01-23-M04 (update)
  • FOSTEMSAVIR TROMETHAMINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • RUKOBIA
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100347-PIP01-21-M01 (update)
  • Respiratory syncytial virus vaccine (bivalent, recombinant)
  • Prevention of lower respiratory tract disease caused by respiratory syncytial virus via maternal immunisation.
  • Abrysvo powder and solvent for solution for injection
  • Abrysvo powder and solvent for solution for injection
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102198-PIP01-25
  • Humanized IgG1 monoclonal antibody against thymic stromal lymphopoietin
  • Treatment of nasal polyposis
  • Oto-Rhino-Laryngology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100392-PIP01-21-M07 (update)
  • Highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2); Tozinameran; Famtozinameran; Riltozinameran; Raxtozinameran; Bretovameran Cemivameran; COVID-19 mRNA Vaccine
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 15/15 micrograms per dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 1.5/1.5 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty LP.8.1 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty LP.8.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial COVID-19 mRNA Vaccine
  • Comirnaty LP.8.1 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection, single dose vial, Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 3 micrograms/dose concentrate for dispersion for injection, COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine
  • Comirnaty Omicron JN.1 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102189-PIP01-25
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
  • Treatment of generalised myasthenia gravis
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100913-PIP01-23-M02 (update)
  • mRNA that encodes for the NTD and RBD epitopes of the spike glycoprotein of SARS-CoV- 2 (mRNA-1283)
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101880-PIP01-25
  • Duvakitug
  • Treatment of ulcerative colitis
  • Gastroenterology-Hepatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102330-PIP01-26
  • Vimseltinib
  • Treatment of tenosynovial giant cell tumour
  • ROMVIMZA
  • ROMVIMZA
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100349-PIP01-21-M04 (update)
  • Rezafungin acetate
  • Treatment of invasive candidiasis
  • Rezzayo
  • Rezzayo
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100286-PIP01-21-M02 (update)
  • USTEKINUMAB
  • Treatment of ulcerative colitis
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • STELARA
  • Stelara
  • STELARA
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Stelara
  • Gastroenterology-Hepatology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100966-PIP01-23-M02 (update)
  • SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion homodimer - Omicron LP.8.1-LP.8.1 variant
  • selvacovatein
  • damlecovatein
  • Prevention of coronavirus disease 2019 (COVID-19)
  • BIMERVAX, BIMERVAX XBB.1.16, BIMERVAX LP.8.1
  • Bimervax
  • Bimervax
  • BIMERVAX
  • BIMERVAX
  • BIMERVAX XBB.1.16
  • BIMERVAX XBB.1.16
  • BIMERVAX XBB.1.16
  • BIMERVAX LP.8.1
  • BIMERVAX LP.8.1
  • BIMERVAX LP.8.1
  • Bimervax
  • BIMERVAX XBB.1.16
  • BIMERVAX LP.8.1
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100249-PIP01-21-M04 (update)
  • BUDESONIDE
  • GLYCOPYRRONIUM
  • FORMOTEROL FUMARATE DIHYDRATE
  • Treatment of asthma
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • BREZTRI AEROSPHERE
  • BREZTRI AEROSPHERE
  • Pneumology - Allergology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102221-PIP01-25
  • Zanzalintinib
  • Treatment of colorectal cancer
  • Treatment of renal cell carcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100517-PIP01-22-M06 (update)
  • APREMILAST
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
  • Otezla 10 mg, 20 mg, 30 mg film coated tablets, Otezla 30 mg film coated tablets
  • Immunology -Rheumatology-Transplantation
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102194-PIP01-25
  • Zanidatamab
  • Treatment of gastric, gastroesophageal junction and oesophageal adenocarcinoma.
  • Ziihera
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100211-PIP01-21-M02 (update)
  • VOLANESORSEN SODIUM
  • Familial chylomicronemia syndrome (FCS)
  • Waylivra 285 mg solution for injection in pre-filled syringe
  • Endocrinology-Gynaecology-Fertility-metabolism
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102196-PIP01-25
  • [4-(1-Methyl-1H-pyrazol-4-yl)-benzyl]-{6-[7-(3-pyrrolidin-1-yl-propoxy)- imidazo[1,2-a]pyridin-3-yl]-pyrimidin-4-yl}-amine
  • Treatment of gastrointestinal stromal tumours
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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