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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check Sort descending	Date Published
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-100152-PIP01-21	cosibelimab	Treatment of cutaneous squamous cell carcinoma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	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-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-100074-PIP01-21	GABAPENTIN	Treatment of Postherpetic Neuralgia	Gralise	Neurology Pain	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/12/2021
MHRA-100081-PIP01-21	Zibotentan DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE	Treatment of Chronic Kidney Disease	Not available at present	Other: Renal Disease	W: decision granting a waiver in all age groups for the listed condition(s).	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
MHRA-100111-PIP01-21	DORAVIRINE Islatravir	Treatment of human immunodeficiency virus-1 (HIV-1) infection.		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	17/12/2021
MHRA-100131-PIP01-21	ATEZOLIZUMAB	Treatment of all malignant neoplasms (except CNS tumours, haematopoietic, lymphoid neoplasms)	Tecentriq Tecentriq Tecentriq Tecentriq	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/12/2021
MHRA-100128-PIP01-21-M01 (update)	bis-choline tetrathiomolybdate	Treatment of Wilson disease		Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100148-PIP01-21-M01 (update)	LENVATINIB MESILATE	Treatment of all conditions included in the category of malignant neoplasms	Lenvima Kisplyx Lenvima Kisplyx Lenvima Kisplyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100142-PIP01-21	Synthetic Hypericin	Treatment of cutaneous T-cell lymphoma	HyBryte	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	17/12/2021
MHRA-100154-PIP01-21-M01 (update)	Cotadutide	Treatment of Type 2 Diabetes Mellitus	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021
MHRA-100160-PIP01-21-M01 (update)	TOCILIZUMAB	Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy	RoActemra RoActemra	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	17/12/2021

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