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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-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
MHRA-100623-PIP01-22-M03 (update)
  • NIRAPARIB TOSYLATE MONOHYDRATE
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoetic and lymphoid malignancies)
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Zejula
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100959-PIP01-23-M03 (update)
  • DOSTARLIMAB
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid malignancies)
  • Jemperli
  • Jemperli
  • Jemperli
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
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-102230-PIP01-25-M01 (update)
  • Rebisufligene etisparvovec
  • Treatment of mucopolysaccharidosis IIIA
  • Not available at present
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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