Search Filters:

The items contained in the list are being used to filter the search results. Click them to remove them from the search filter.
Displaying 1 - 20 of 1087
PIPS Search Results
PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published Sort ascending
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. Yes Full Compliance Check Granted
MHRA-100069-PIP01-21-M01 (update)
  • RIBOCICLIB SUCCINATE
  • Treatment of neuroblastoma
  • KISQALI
  • KISQALI
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100075-PIP01-21-M03 (update)
  • leniolisib
  • Treatment of activated phosphoinositide 3-kinase delta (δ) syndrome (APDS)
  • Joenja
  • Joenja
  • Joenja
  • Joenja
  • Immunology -Rheumatology-Transplantation
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100447-PIP01-22-M03 (update)
  • Tirzepatide
  • Treatment of Type 2 diabetes mellitus.
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro
  • Mounjaro, Zepbound
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101678-PIP01-24
  • Mirdametinib
  • Treatment of neurofibromatosis type 1
  • Not available at present
  • Gomeklio
  • Gomeklio
  • Neurology
  • Oncology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-102497-PIP01-26
  • PONATINIB
  • PONATINIB HYDROCHLORIDE
  • Treatment of chronic myeloid leukaemia (CML)
  • Treatment of acute lymphoblastic leukaemia
  • Ponatinib Incyte
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Iclusig
  • Haematology-Hemostaseology
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100023-PIP01-21-M02 (update)
  • bimekizumab
  • Treatment of psoriasis
  • Bimzelx
  • Bimzelx
  • Bimzelx
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
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) Yes Partial Compliance Check Granted
MHRA-100249-PIP01-21-M04 (update)
  • BUDESONIDE
  • GLYCOPYRRONIUM
  • FORMOTEROL FUMARATE DIHYDRATE
  • Treatment of asthma
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • BREZTRI AEROSPHERE
  • BREZTRI AEROSPHERE
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100840-PIP01-23-M01 (update)
  • Odronextamab
  • Treatment of mature B cell malignancies
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-102181-PIP01-25
  • Tinlarebant
  • Treatment of Stargardt disease
  • Ophthamology
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) Yes Partial Compliance Check Granted
MHRA-102467-PIP01-26-M01 (update)
  • HUMAN FIBRINOGEN
  • Treatment of congenital fibrinogen deficiency
  • Fesilty 1 g Powder and solvent for solution for injection/infusion
  • Fesilty
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-101249-PIP01-23-M01 (update)
  • Tovorafenib
  • Treatment of paediatric low grade glioma
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-101513-PIP01-24-M02 (update)
  • ERTUGLIFLOZIN L-PYROGLUTAMIC ACID
  • Treatment of Type 2 Diabetes Mellitus
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Steglatro
  • Endocrinology-Gynaecology-Fertility-metabolism
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Full Compliance Check Granted
MHRA-100993-PIP01-23-M03 (update)
  • QUIZARTINIB DIHYDROCHLORIDE
  • Treatment of acute myeloid leukaemia
  • VANFLYTA
  • VANFLYTA
  • Oncology
PM: decision on the application for modification of an agreed paediatric investigation plan. Yes Partial Compliance Check Granted
MHRA-100216-PIP01-21-M06 (update)
  • TRALOKINUMAB
  • Treatment of atopic dermatitis.
  • Adtralza
  • Adtralza
  • Adtralza
  • Adbry
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Adtralza
  • Dermatology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100249-PIP01-21-M05 (update)
  • BUDESONIDE
  • GLYCOPYRRONIUM
  • FORMOTEROL FUMARATE DIHYDRATE
  • Treatment of asthma
  • Trixeo Aerosphere
  • Trixeo Aerosphere
  • BREZTRI AEROSPHERE
  • BREZTRI AEROSPHERE
  • Pneumology - Allergology
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-100294-PIP01-21-M02 (update)
  • BENRALIZUMAB
  • Treatment of asthma
  • FASENRA
  • FASENRA
  • FASENRA
  • Other: Respiratory, thoracic and mediastinal disorders, Immune system disorders
PM: decision on the application for modification of an agreed paediatric investigation plan. No
MHRA-102456-PIP01-26
  • Saruparib
  • Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue neoplasms)
  • Oncology
W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-100406-PIP01-21-M04 (update)
  • Marstacimab
  • Treatment of congenital haemophilia A
  • Treatment of congenital haemophilia B
  • Hympavzi 150 mg solution for injection in pre-filled syringe
  • Hympavzi 150 mg solution for injection in pre-filled pen
  • Haematology-Hemostaseology
PM: decision on the application for modification of an agreed paediatric investigation plan. No