Displaying 1 - 20 of 1220
PIPS Search Results
PIP Number Active Substance Sort descending Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101550-PIP01-24
  • Troriluzole Hydrochloride
  • Treatment of hereditary spinocerebellar ataxia
  • Neurology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) No
MHRA-101674-PIP01-24
  • Linvoseltamab
  • Treatment of multiple myeloma
  • LYNOZYFIC
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101676-PIP01-24
  • HUMAN ANTI-D IMMUNOGLOBULIN
  • Prevention of Rhesus (Rh) isoimmunisation
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Immunorho
  • Haematology-Hemostaseology
  • Other: Immunology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101704-PIP01-24
  • Nucresiran sodium
  • Treatment of transthyretin amyloidosis
  • Neurology
  • Cardiovascular Diseases
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101718-PIP01-24
  • Human alpha-1-proteinase inhibitor immunoglobulin G fusion protein, recombinant
  • Treatment of emphysema secondary to congenital deficiency of alpha-1 antitrypsin
  • Pneumology - Allergology
W: decision granting a waiver in all age groups for the listed condition(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-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-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-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-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-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-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-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-100392-PIP01-21-M06 (update)
  • Highly purified single-stranded, 5’-capped mRNA encoding full-length SARS-CoV-2 spike protein (BNT162b2)
  • TOZINAMERAN
  • FAMTOZINAMERAN
  • RILTOZINAMERAN
  • RAXTOZINAMERAN
  • Prevention of coronavirus disease 2019 (COVID-19)
  • Comirnaty
  • Comirnaty 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 15/15 micrograms per dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 1.5/1.5 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 3 micrograms/dose concentrate for dispersion for injection, COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron JN.1 3 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Comirnaty Omicron KP.2 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial COVID-19 mRNA Vaccine (nucleoside modified)
  • Infectious 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-100913-PIP01-23-M01 (update)
  • mRNA encoding for the linked NTD and RBD domains 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-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-101189-PIP01-23
  • N-((1R,2R)-2-methoxycyclobutyl)-7-(methylamino)-5-((2-oxo-2H-[1,2'-bipyridin]-3-yl)amino)pyrazolo[1,5-a]pyrimidine-3-carboxamide
  • Treatment of psoriasis
  • Dermatology
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-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