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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-100183-PIP01-21-M04 (update)
  • AZILSARTAN MEDOXOMIL
  • Treatment of hypertension
  • Edarbi
  • Edarbi
  • Cardiovascular Diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100237-PIP01-21-M02 (update)
  • 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)
  • 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
  • Prevention of influenza infection
  • Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (QIV-HD)
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101748-PIP01-24
  • Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the strains: A/(H1N1)-Like Virus Antigen A/(H3N2)-Like Virus Antigen B/-Like Virus Antigen
  • Prevention of influenza
  • Cell-based Trivalent Influenza Vaccine Seqirus suspension for injection in pre-filled syringe
  • FLUCELVAX
  • FLUCELVAX
  • FLUCELVAX
  • Vaccines
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-100225-PIP01-21-M03 (update)
  • PARATHYROID HORMONE
  • Treatment of hypoparathyroidism
  • Natpar
  • Natpar
  • Natpar
  • Endocrinology-Gynaecology-Fertility-metabolism
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101761-PIP01-24
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2)
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage)
  • Prevention of influenza infection
  • Adjuvanted Trivalent Influenza Vaccine (Surface Antigen, Inactivated) Seqirus suspension for injection in pre-filled syringe
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Fluad
  • Vaccines
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101407-PIP01-24-M01 (update)
  • chikungunya virus virus-like particle
  • Prevention of chikungunya virus disease
  • Infectious diseases
  • Vaccines
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100714-PIP01-22-M02 (update)
  • Gepotidacin
  • Treatment of uncomplicated gonorrhoea
  • Blujepa
  • Infectious diseases
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101789-PIP01-25
  • Vixarelimab
  • Treatment of idiopathic pulmonary fibrosis (IPF)
  • Pneumology - Allergology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101408-PIP01-24
  • Human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells (rocatinlimab)
  • Treatment of asthma
  • Pneumology - Allergology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101752-PIP01-24
  • BELZUTIFAN
  • Treatment of neuroendocrine tumours
  • Welireg
  • Welireg
  • Welireg
  • Welireg
  • Welireg
  • Welireg
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101750-PIP01-24
  • Tenapanor
  • Treatment of hyperphosphataemia
  • Xphozah
  • Phozevel
  • Uro-Nephrology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101278-PIP01-23
  • oveporexton
  • Treatment of narcolepsy.
  • Treatment of idiopathic hypersomnia.
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100087-PIP01-21-M03 (update)
  • LACOSAMIDE
  • Treatment of generalised epilepsy and epileptic syndromes.
  • VIMPAT
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100326-PIP02-24
  • Gemcitabine (hydrochloride)
  • Treatment of malignant bladder neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100311-PIP02-24
  • Cetrelimab
  • Treatment of malignant bladder neoplasms
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100455-PIP01-22-M02 (update)
  • IXAZOMIB
  • Treatment of multiple myeloma
  • Treatment of lymphoid malignancies (excluding multiple myeloma)
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Ninlaro
  • Oncology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101661-PIP01-24
  • RUXOLITINIB PHOSPHATE
  • Treatment of atopic dermatitis
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • OPZELURA
  • Dermatology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101579-PIP01-24
  • AZD0780
  • Treatment of elevated cholesterol
  • Treatment of mixed dyslipidaemia
  • AZD0780
  • Cardiovascular Diseases
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-100949-PIP01-23-M02 (update)
  • Delandistrogene moxeparvovec
  • Treatment of Duchenne muscular dystrophy
  • Elevidys
  • Neurology
 PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101731-PIP01-24
  • Pridopidine hydrochloride
  • Treatment of Huntington disease (HD)
  • Nurzigma
  • Neurology
 P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
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