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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort ascending
MHRA-100125-PIP01-21	PEMBROLIZUMAB vibostolimab	Malignant neoplasms (except CNS, haematopoietic, lymphoid tissue melanoma) Malignant CNS neoplasms		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100136-PIP01-21	PEMBROLIZUMAB quavonlimab	All conditions of malignant neoplasms (except haematopoietic, lymphoid tissue and melanoma).		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100490-PIP01-22-M01 (update)	nirsevimab (MEDI8897)	Prevention of lower respiratory tract infection caused by respiratory syncytial virus (RSV).	Beyfortus	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100370-PIP01-21-M01 (update)	EX VIVO EXPANDED AUTOLOGOUS HUMAN CORNEAL EPITHELIAL CELLS CONTAINING STEM CELLS	Treatment of limbal stem cell deficiency due to ocular burns	Holoclar Holoclar Holoclar	Ophthamology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100328-PIP01-21-M01 (update)	METRELEPTIN	Treatment of lipodystrophy	Myalepta Powder for Solution for Injection Myalepta Myalepta	Endocrinology-Gynaecology-Fertility-metabolism	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100341-PIP01-21-M01 (update)	ISAVUCONAZONIUM SULFATE	Treatment of invasive aspergillosis Treatment of mucormycosis	Cresemba Cresemba Cresemba	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100233-PIP01-21-M01 (update)	CABOZANTINIB	Treatment of malignant solid tumours	Cabometyx Cometriq Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Aptimetyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cabometyx Cometriq Cabometyx Cometriq Cabometyx	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100260-PIP01-21-M01 (update)	CEMIPLIMAB	Treatment of all malignant neoplasms (except haematopoietic and lymphoid tissue)	Libtayo Libtayo	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100158-PIP01-21-M01 (update)	PEMBROLIZUMAB	Treatment of Hodgkin lymphoma	Keytruda Keytruda	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	27/09/2022
MHRA-100487-PIP01-22	exebacase	Treatment of Staphylococcus aureus bacteraemia		Infectious diseases	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100454-PIP01-22	adagrasib	Treatment of all solid and haematological malignancies		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100374-PIP01-21	Adeno-associated virus serotype 1 vector containing the human progranulin GRN gene	Treatment of frontotemporal dementia		Neurology	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100295-PIP01-21	Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; (ABBV-154).	Treatment of polymyalgia rheumatica		Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	27/09/2022
MHRA-100226-PIP01-21	Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; ABBV-154	Treatment of chronic idiopathic arthritis (rheumatoid, psoriatic, JIA, ankylosing spondylitis)		Immunology -Rheumatology-Transplantation	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100178-PIP01-21	DTX401 (a nonreplicating, recombinant adeno-associated virus serotype 8 vector that contains a codon-optimized, wild-type human glucose-6-phosphatase (G6PC) gene)	Treatment of glycogen storage disease type 1a (GSDIa)	Not available at present	Endocrinology-Gynaecology-Fertility-metabolism	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100151-PIP01-21	CANNABIDIOL	Treatment of epilepsy with myoclonic-atonic seizures (EMAS)	Epidyolex Epidyolex Epidyolex Epidiolex Epidyolex Epidyolex Epidiolex	Neurology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100115-PIP01-21	Dersimelagon	Treatment of erythropoietic protoporphyria Treatment of X-linked protoporphyria	Not available at present	Dermatology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No	27/09/2022
MHRA-100190-PIP01-21	Ordesekimab	Treatment of coeliac disease		Gastroenterology-Hepatology Immunology -Rheumatology-Transplantation	W: decision granting a waiver in all age groups for the listed condition(s).	No	29/07/2022
MHRA-100122-PIP01-21	olpasiran	Prevention of cardiovascular events		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	29/07/2022
MHRA-100294-PIP01-21-M01 (update)	BENRALIZUMAB	Treatment of asthma	FASENRA FASENRA FASENRA FASENRA FASENRA FASENRA PEN FASENRA	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	29/07/2022

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