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Displaying 161 - 180 of 199
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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
MHRA-101392-PIP01-24
  • Influenza Virus Type A, H1N1
  • Influenza Virus Type A, H3N2
  • Influenza Virus Type B, Victoria lineage
  • Prevention of influenza infection
  • Fluenz
  • Vaccines
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted
MHRA-101162-PIP01-23-M01 (update)
  • LETERMOVIR
  • Prevention of cytomegalovirus infection
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PRVEYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • PREVYMIS
  • tablet
  • PREVYMIS
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101234-PIP01-23-M01 (update)
  • ALIROCUMAB
  • Treatment of elevated cholesterol
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Praluent
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101293-PIP01-23-M01 (update)
  • METHOXYFLURANE
  • Treatment of acute pain
  • Penthrox
  • Pain
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100989-PIP01-23-M01 (update)
  • DERMATOPHAGOIDES FARINAE
  • DERMATOPHAGOIDES PTERONYSSINUS
  • Treatment of asthma
  • Treatment of allergic rhinitis
  • ACARIZAX and associated names
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • AMITEND
  • ACARIZAX
  • AITARO
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACARIZAX
  • ACCARIZAX
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes
MHRA-100442-PIP01-22-M02 (update)
  • TALIMOGENE LAHERPAREPVEC
  • Treatment of melanoma
  • Imlygic
  • Imlygic
  • Imlygic
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101003-PIP01-23-M01 (update)
  • garadacimab
  • Prevention of hereditary angioedema
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101053-PIP01-23-M01 (update)
  • DOLUTEGRAVIR
  • ABACAVIR
  • LAMIVUDINE
  • Treatment of human immunodeficiency virus (HIV-1) infection
  • TRIUMEQ
  • TRIUMEQ
  • Infectious diseases
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101131-PIP01-23-M01 (update)
  • BLINATUMOMAB
  • Treatment of acute lymphoblastic leukaemia
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCTYO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • BLINCYTO
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100932-PIP01-23-M02 (update)
  • Defatted powder of peanuts
  • Treatment of peanut allergy
  • Palforzia
  • Palforzia
  • Palforzia
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100642-PIP01-22-M02 (update)
  • Tremelimumab
  • Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).
  • IMJUDO
  • Tremelimumab AstraZeneca
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101149-PIP01-23-M01 (update)
  • elosulfase alfa (recombinant human N-acetylgalactosamine-6-sulfatase)
  • Treatment of mucopolysaccharidosis, type IVA (Morquio-A syndrome)
  • Vimizim 1mg/ml concentrate for solution for infusion
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100098-PIP01-21-M02 (update)
  • ATALUREN
  • Treatment of dystrophinopathy
  • Translarna
  • Neurology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100787-PIP01-22
  • Repotrectinib
  • Treatment of all conditions included in the category of malignant neoplasm (except haematopoietic neoplasms)
  • Not available at present
  • Oncology
  • Other: Not Applicable
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes
MHRA-100741-PIP01-22
  • CRISANTASPASE
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of lymphoblastic lymphoma
  • Enrylaze
  • Rylaze
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Full Compliance Check Granted