My HPRA: Register

ISENTRESS

100 Milligram Granules for Oral Suspension

Merck Sharp & Dohme LtdEU/1/07/436/005

Main Information

Trade NameISENTRESS
Active SubstancesRALTEGRAVIR
Strength100 Milligram
Dosage FormGranules for Oral Suspension
Licence HolderMerck Sharp & Dohme Ltd
Licence NumberEU/1/07/436/005

Group Information

ATC CodeJ05AX08 Other antivirals

Status

Authorised/WithdrawnAuthorised
Licence Issued22/08/2014
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back
Follow medicine

Print