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Isentress

400 milligram(s) Film-coated tablet

Merck Sharp and Dohme LimitedEU/1/07/436/1-2

Main Information

Trade NameIsentress
Active SubstancesRaltegravir potassium
Strength400 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderMerck Sharp and Dohme Limited
Licence NumberEU/1/07/436/1-2

Group Information

ATC CodeJ05AX Other antivirals
J05AX08 raltegravir

Status

Authorised/WithdrawnAuthorised
Licence Issued20/12/2007
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing StatusUnknown

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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