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Sodium Iodide (I131) Capsule T 37-7400 MBq hard capsule



Curium Netherlands B.V.PA0690/006/002

Main Information

Trade NameSodium Iodide (I131) Capsule T 37-7400 MBq hard capsule
Active SubstancesSodium iodide (131 i)
Dosage FormCapsule, hard
Licence HolderCurium Netherlands B.V.
Licence NumberPA0690/006/002

Group Information

ATC CodeV10XA Iodine (131I) compounds
V10XA01 sodium iodide (131I)

Status

License statusAuthorised
Licence Issued29/06/2001
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceParametric Release for Sterility approved on 26th November 2009 in accordance with CPMP/QWP/3015/00, Note for Guidance on Parametric Release and Annex 17 to the EU guide on Good Manufacturing Practice provided the following conditions apply: 1. The approval is valid only for the GE Healthcare Ireland, IDA Business Park, Carrigtohill in Co. Cork and GE Healthcare AS, P.O. Box 4220 Nydalen, NO-0401 Oslo, Norway and for the product manufactured in the 50ml and 100ml polypropylene bottles as specified in section 6.5 of the SPC. 2. In accordance with European Pharmacopoeia general monograph on parental products, which includes the requirements that "Parental products comply with the test for sterility', the sterility test remains a requirement for all sterilised products even where parametric release is approved, and should therefore be retained in the finished product specifications even though not routinely conducted batch by batch.
Marketing StatusMarketed

Documents

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