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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Compliance outcome	Date Published Sort descending
MHRA-100023-PIP01-21-M01 (update)	bimekizumab	Treatment of psoriasis	Bimzelx	Dermatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/11/2021
MHRA-100025-PIP01-21-M01 (update)	LAROTRECTINIB	Treatment of malignant neoplasms of the central nervous system	VITRAKVI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/11/2021
MHRA-100036-PIP01-21-M01 (update)	FERRIC MALTOL	Treatment of Iron deficiency anaemia (IDA)	FERACCRU FERACCRU ACCRUFER FERACCRU	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/11/2021
MHRA-100065-PIP01-21-M01 (update)	TICAGRELOR	Prevention of thromboembolic events	Brilique Brilique Brilique Brilique	Cardiovascular Diseases Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	03/11/2021
MHRA-100064-PIP01-21-M01 (update)	Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid and Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid	Prevention of invasive meningococcal disease	MenQuadfi MenQuadfi	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		03/11/2021
MHRA-100067-PIP01-21-M01 (update)	nirsevimab (MEDI8897) (Anti-respiratory syncytial virus human IgG1κ monoclonal antibody)	Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).		Infectious diseases Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/11/2021
MHRA-100046-PIP01-21-M01 (update)	cenobamate	Treatment of epilepsy	ONTORZY Xcopri	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	03/11/2021
MHRA-100083-PIP01-21-M01 (update)	Human Fibrinogen (INN) / Human Thrombin (INN) HUMAN THROMBIN HUMAN FIBRINOGEN	Treatment of: haemorrhage from a surgical procedure CSF leakage from a neurosurgical procedure	EVICEL, Solution for sealant EVARREST, Sealant matrix (withdrawn EU MAA) EVICEL EVICEL EVICEL	Other: blood-derived topical haemostats	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		15/11/2021
MHRA-100049-PIP01-21-M01 (update)	IBRUTINIB	Treatment of mature B-cell neoplasm	Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica Imbruvica	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/11/2021
MHRA-100059-PIP01-21-M01 (update)	roxadustat	Treatment of anaemia due to chronic disorders	EVRENZO EVRENZO	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/12/2021
MHRA-100024-PIP01-21-M01 (update)	LAROTRECTINIB	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)	VITRAKVI	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/12/2021
MHRA-100092-PIP01-21-M01 (update)	VENETOCLAX	Haematopoietic and lymphoid malignant neoplasms Treatment of solid tumour malignant neoplasms		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/12/2021
MHRA-100235-PIP01-21-M01 (update)	Sotrovimab	Treatment of coronavirus disease 2019 (COVID-19)	Xevudy	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		03/12/2021
MHRA-100102-PIP01-21-M01 (update)	MOMETASONE FUROATE INDACATEROL ACETATE	Treatment of asthma	Atectura Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler Atectura Breezhaler Atectura Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler Atectura Breezhaler and its duplicate authorisation Bemrist Breezhaler	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100039-PIP01-21-M01 (update)	Cotadutide	Treatment of non-alcoholic steatohepatitis (NASH)		Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Partial Compliance Check Granted	17/12/2021
MHRA-100040-PIP01-21-M01 (update)	Cotadutide	Treatment of Type 2 Diabetes Mellitus		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100094-PIP01-21-M01 (update)	DORAVIRINE LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE	Treatment of human immunodeficiency virus-1 (HIV-1) infection	Delstrigo	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100095-PIP01-21-M01 (update)	DORAVIRINE	Treatment of human immunodeficiency virus-1 (HIV-1) infection	Pifeltro	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100097-PIP01-21-M01 (update)	eladocagene exuparvovec	Treatment of Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency	Upstaza	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021
MHRA-100098-PIP01-21-M01 (update)	ATALUREN	Treatment of dystrophinopathy	Translarna Translarna Translarna Translarna Translarna Translarna Translarna Translarna	Neurology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		17/12/2021

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