Displaying 341 - 360 of 1021
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-101701-PIP01-24
  • ribitol
  • Treatment of Limb-girdle muscular dystrophy
  • Other: Musculoskeletal
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101606-PIP01-24
  • telisotuzumab adizutecan (ABBV-400)
  • Treatment of gastric and gastroesophageal junction adenocarcinoma
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101342-PIP01-24-M02 (update)
  • ESKETAMINE HYDROCHLORIDE
  • Treatment of Major Depressive Disorder
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Spravato
  • Psychiatry
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101177-PIP01-23-M01 (update)
  • navenibart
  • Treatment of hereditary angioedema
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-101103-PIP01-23-M01 (update)
  • FINERENONE
  • Treatment of heart failure
  • Kerendia
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100878-PIP01-23-M01 (update)
  • VIBEGRON
  • Treatment of myoneurogenic bladder disorders
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Obgemsa
  • Uro-Nephrology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100424-PIP01-22-M01 (update)
  • zilebesiran sodium
  • Treatment of hypertension
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100214-PIP01-21-M05 (update)
  • RAVULIZUMAB
  • Treatment of atypical haemolytic uraemic syndrome (aHUS)
  • Ultomiris
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100213-PIP01-21-M05 (update)
  • RAVULIZUMAB
  • Treatment of paroxysmal nocturnal haemoglobinuria
  • Ultomiris
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
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-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-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