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

Main Information

Trade NameIsentress
Active SubstancesRaltegravir potassium
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


License statusAuthorised
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


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