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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area	Decision Type	Compliance Check	Date Published Sort descending
MHRA-100035-PIP01-21	POVIDONE-IODINE ISOPROPYL ALCOHOL	Prevention of infection prior to invasive procedures	PurPrep	Other: Antiseptic	W: decision granting a waiver in all age groups for the listed condition(s).	No	21/10/2022
MHRA-100243-PIP01-21	DAPAGLIFLOZIN 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro-2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro-2H-1,4-benzoxazin-3-yl}-N-methylacetamide (AZD9977)	Prevention of cardiovascular events in patients with chronic heart failure		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	21/10/2022
MHRA-100177-PIP01-21-M01 (update)	INFLUENZA B/YAMAGATA/16/88-LIKE VIRUS ANTIGEN INFLUENZA A/ (H3N2)-LIKE VIRUS ANTIGEN INFLUENZA B/VICTORIA/2/87-LIKE VIRUS ANTIGEN INFLUENZA A/ (H1N1)-LIKE VIRUS ANTIGEN	Prevention of influenza	FLUCELVAX TETRA FLUCELVAX TETRA FLUCELVAX QUADRIVALENT FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX QUAD FLUCELVAX TETRA	Vaccines	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	21/10/2022
MHRA-100234-PIP01-21	(S)-N-(1-amino-4-(dimethylamino)-1-oxobutan-2-yl)-5-(2,4-difluorophenoxy)-1-isobutyl-1H-indazole-6-carboxamide	Treatment of dilated cardiomyopathy due to lamin A/C gene mutations		Cardiovascular Diseases	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100198-PIP01-21-M01 (update)	RURIOCTOCOG ALFA PEGOL	Treatment and prophylaxis of bleeding in patients with haemophilia A	Adynovi	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100284-PIP01-21-M01 (update)	MEXILETINE HYDROCHLORIDE	Treatment of myotonic disorders		Other: Muscle disorders	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100283-PIP01-21-M01 (update)	USTEKINUMAB	Treatment of Crohn's disease	Stelara Stelara Stelara Stelara Stelara Stelara Stelara	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100286-PIP01-21-M01 (update)	USTEKINUMAB	Treatment of ulcerative colitis	Stelara Stelara Stelara Stelara Stelara Stelara Stelara	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100321-PIP01-21-M01 (update)	GUSELKUMAB	Chronic idiopathic arthritis (including rheumatoid, psoriatic, ankylosing spondylitis and JIA)	TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA TREMFYA	Immunology -Rheumatology-Transplantation	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100300-PIP01-21-M01 (update)	DARUNAVIR COBICISTAT	Treatment of HIV-1 Infection	REZOLSTA REZOLSTA REZOLSTA	Infectious diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100325-PIP01-21-M01 (update)	NALDEMEDINE	Treatment of opioid-induced constipation	Rizmoic Rizmoic SYMPROIC SYMPROIC	Gastroenterology-Hepatology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100343-PIP01-21-M01 (update)	MACITENTAN	Treatment of pulmonary arterial hypertension systemic sclerosis idiopathic pulmonary fibrosis	Opsumit Opsumit Opsumit Opsumit Opsumit Opsumit Opsumit Zependo Opsumit Opsumit Opsumit Opsumit Opsumit Zependo Opsumit Opsumit Opsumit Opsumit	Cardiovascular Diseases	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100334-PIP01-21-M01 (update)	INDACATEROL ACETATE GLYCOPYRRONIUM BROMIDE MOMETASONE FUROATE	Treatment of asthma	Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Enerzair Breezhaler Zimbus Breezhaler Zimbus Breezhaler Zimbus Breezhaler Zimbus Breezhaler Zimbus Breezhaler	Pneumology - Allergology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100268-PIP01-21-M01 (update)	INOTUZUMAB OZOGAMICIN	Treatment of B cell acute lymphoblastic leukaemia	Besponsa Besponsa	Haematology-Hemostaseology Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100187-PIP01-21-M02 (update)	VONICOG ALFA	Treatment of von Willebrand Disease	veyvondi Vonvendi veyvondi Vonvendi veyvondi Vonvendi veyvondi	Haematology-Hemostaseology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No	02/11/2022
MHRA-100176-PIP01-21	favezelimab PEMBROLIZUMAB	Malignant neoplasms (except CNS, haematopoietic, lymphoid-tissue-& melanoma) Neoplasms of CNS		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100246-PIP01-21	MK-1026	Treatment of mature B-cell malignancies		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100326-PIP01-21	GEMCITABINE HYDROCHLORIDE	Treatment of urothelial carcinoma	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100311-PIP01-21	Cetrelimab	Treatment of urothelial carcinoma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022
MHRA-100384-PIP01-21	datopotamab deruxtecan	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No	02/11/2022

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