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Takeda Announces China NMPA Approval of LIVTENCITY maribavir for the Treatment of Adults With Posttransplant Cytomegalovirus CMV Refractory to Prior Therapies

Takeda Announces China NMPA Approval of LIVTENCITY maribavir for the Treatment of Adults With Posttransplant Cytomegalovirus CMV Refractory to Prior Therapies ....

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Takeda Announces China NMPA Approval of LIVTENCITY® (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Refractory to Prior Therapies

Takeda Announces China NMPA Approval of LIVTENCITY® (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Refractory to Prior Therapies
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Orphan medicinal products in Great Britain

Orphan medicinal products
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
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The MHRA offers incentives in the form of market exclusivity and full or partial refunds for marketing authorisation fees to encourage the development of medicines in rare diseases. Waiver from scientific advice fees will also be available for UK based
SMEs.
Application process
The MHRA is responsible for reviewing applications from companies for orphan designation at the time of a marketing authorisation application (
MAA).
There is no pre-marketing authorisation orphan designation.
Products with an orphan designation in the EU can be considered for a Great Britain orphan marketing authorisation (MA). In accordance with Regulation 50G of the Human Medicines Regulation 2012 (as amended), a UK-wide orphan marketing authorisation can only be cons ....

United Kingdom , Great Britain , Commission On Human Medicines , United Kingdom Licensing Authority , Customer Services Centre , United Kingdom Rare , Authorisation Applicants , Human Medicines , Marketing Authorisation , Products Characteristics , Trade Association , ஒன்றுபட்டது கிஂக்டம் , நன்று பிரிட்டன் , தரகு ஆன் மனிதன் மருந்துகள் , ஒன்றுபட்டது கிஂக்டம் உரிமம் அதிகாரம் , வாடிக்கையாளர் சேவைகள் மையம் , ஒன்றுபட்டது கிஂக்டம் ரேர் , மனிதன் மருந்துகள் , ப்ராடக்ட்ஸ் பண்புகள் , வர்த்தகம் சங்கம் ,