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Displaying 201 - 220 of 250
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
MHRA-102064-PIP01-25-M01 (update)
  • MERCAPTAMINE HYDROCHLORIDE
  • Treatment of cystinosis.
  • Cystadrop
  • Cystadrops
  • Cystadrops
  • Cystadrops
  • Ophthamology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101905-PIP01-25
  • FUROSEMIDE
  • Treatment of fluid retention
  • Cardiovascular Diseases
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101995-PIP01-25-M01 (update)
  • ISOFLURANE
  • Sedation of mechanically ventilated patients
  • Sedaconda and associated names
  • Other: Sedation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
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-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-101773-PIP01-24-M01 (update)
  • Tabelecleucel
  • Treatment of Epstein-Barr virus associated post-transplant lymphoproliferative disorder.
  • Ebvallo
  • Ebvallo
  • Ebvallo
  • Ebvallo
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101725-PIP01-24
  • GUSELKUMAB
  • Treatment of psoriasis
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • TREMFYA
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101711-PIP01-24-M01 (update)
  • IPTACOPAN HYDROCHLORIDE MONOHYDRATE
  • Treatment of C3 glomerulopathy
  • Fabhalta
  • Fabhalta
  • Fabhalta
  • Other: Complement-driven renal disease
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100239-PIP01-21-M02 (update)
  • Multivalent pneumococcal polysaccharide conjugate to carrier protein
  • Prevention of disease caused by Streptococcus pneumoniae
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101596-PIP01-24-M01 (update)
  • Ibrexafungerp
  • Treatment of vulvovaginal candidiasis
  • Prevention of recurrent vulvovaginal candidiasis
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101492-PIP01-24
  • Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)
  • Recombinant Influenza Hemagglutinin-strain A (H3N2 subtype)
  • Recombinant Influenza Hemagglutinin-strain B (RIV3)
  • Prevention of influenza disease
  • Flublok
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-100343-PIP01-21-M04 (update)
  • MACITENTAN
  • Treatment of pulmonary arterial hypertension
  • Treatment of systemic sclerosis
  • Treatment of idiopathic pulmonary fibrosis
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Opsumit
  • Cardiovascular Diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100754-PIP01-22-M01 (update)
  • Live-attenuated La Reunion strain of chikungunya virus
  • Prevention of chikungunya virus disease
  • Vaccines
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101352-PIP01-24-M01 (update)
  • Autologous tumour-infiltrating lymphocytes (LN-144/LN-145)
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • AMTAGVI
  • AMTAGVI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-101107-PIP01-23-M01 (update)
  • BIRCH BARK EXTRACT
  • Treatment of epidermolysis bullosa
  • Filsuvez
  • Filsuvez gel
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100469-PIP01-22-M02 (update)
  • delgocitinib
  • Treatment of chronic hand eczema
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101268-PIP01-23
  • Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H5N1
  • Prevention of pandemic influenza
  • Incellipan
  • Audenz
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-101269-PIP01-23
  • Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen
  • Prevention of zoonotic influenza
  • Celldemic
  • Audenz
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101394-PIP01-24
  • clascoterone
  • Treatment of acne vulgaris
  • Winlevi 10 mg/g cream
  • Dermatology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted