My HPRA: Register

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


Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled syringe



CSL Behring GmbHPA0800/006/002

Main Information

Trade NameRhophylac 300 micrograms / 2 ml, solution for injection in pre-filled syringe
Active SubstancesHuman anti-D immunoglobulin
Dosage FormSolution for injection in pre-filled syringe
Licence HolderCSL Behring GmbH
Licence NumberPA0800/006/002

Group Information

ATC CodeJ06BB Specific immunoglobulins
J06BB01 anti-D (rh) immunoglobulin

Status

License statusAuthorised
Licence Issued17/10/2003
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceBatches marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC as amended.
Marketing StatusMarketed

Documents

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

Print