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Displaying 141 - 160 of 864
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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-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
MHRA-101303-PIP01-23-M01 (update)
  • OBINUTUZUMAB
  • Treatment of glomerulonephritis and nephrotic syndrome
  • Gazyvaro
  • Uro-Nephrology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101882-PIP01-25
  • Pentavalent mRNA vaccine encoding for NoV VP1
  • Prevention of norovirus acute gastroenteritis
  • Not available at present
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101310-PIP01-23
  • apraglutide
  • Treatment of short bowel syndrome
  • Gastroenterology-Hepatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101413-PIP01-24-M02 (update)
  • BLINATUMOMAB
  • Treatment of acute lymphoblastic leukaemia
  • BLINCYTO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100910-PIP01-23-M05 (update)
  • ABEMACICLIB
  • Treatment of glioma
  • Abemaciclib/ Verzenios
  • Verzenios
  • Abemaciclib
  • Verzenios
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100182-PIP01-21-M03 (update)
  • Avalglucosidase alfa
  • Treatment of Pompe disease
  • Nexviadyme
  • Nexviadyme
  • Nexviadyme
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102287-PIP01-25
  • Clostridium botulinum, neurotoxin serotype A/B
  • Treatment of skin wrinkling
  • Neurology
  • Dermatology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-102138-PIP01-25
  • 3-(1-(2-((S)-2-(3-Cyclopropyl-4-fluorophenyl)-3-(3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl)-4-methyl-4,5,6,7-tetrahydro-2H-pyrazolo[4,3-c]pyridine-5-carbonyl)-7-((S)-2,2-dimethyltetrahydro-2Hpyran-4-yl)indolizin-3-yl)cyclopropyl)-1,2,4-oxadiazol-5(4H)-one
  • (AZD5004)
  • Treatment of Type 2 Diabetes Mellitus
  • Endocrinology-Gynaecology-Fertility-metabolism
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-102069-PIP01-25
  • acetyl-L-leucine ((s)-(acetylamino)-4-methylpentanoic acid)
  • Treatment of ataxia telangiectasia
  • T.b.d.
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No