The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Concerta XL 18 mg prolonged-release tablets



Janssen Sciences Ireland UCPA22612/002/001

Main Information

Trade NameConcerta XL 18 mg prolonged-release tablets
Active SubstancesMethylphenidate hydrochloride
Methylphenidate hydrochloride
Methylphenidate hydrochloride
Dosage FormProlonged-release tablet
Licence HolderJanssen Sciences Ireland UC
Licence NumberPA22612/002/001

Group Information

ATC CodeN06BA Centrally acting sympathomimetics
N06BA04 methylphenidate

Status

License statusAuthorised
Licence Issued22/11/2002
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceThis product contains a substance listed in Schedule 2 to the Misuse of Drugs Regulations 1988 (S.I. No. 328 of 1988) as amended.
Marketing StatusMarketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back