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

300 microgram(s) Solution for injection

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
Strength300 microgram(s)
Dosage FormSolution for injection
Licence HolderCSL Behring GmbH
Licence NumberPA0800/006/002

Group Information

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

Status

Authorised/WithdrawnAuthorised
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
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