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Paracetamol 10 mg/ml Solution for Infusion



Laboratoire AGUETTANTPA1968/021/001

Main Information

Trade NameParacetamol 10 mg/ml Solution for Infusion
Active SubstancesParacetamol
Dosage FormSolution for infusion
Licence HolderLaboratoire AGUETTANT
Licence NumberPA1968/021/001

Group Information

ATC CodeN02BE Anilides
N02BE01 paracetamol

Status

License statusAuthorised
Licence Issued01/04/2011
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceFor hospital use only Parametric Release for Sterility approved on 14th March 2014 in accordance with CPMP/QWP/3015/99, 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 MacoPharma SAS, Rue Lorthiois, 59420 Mouvaux, France site and for the product sterilized in the containers specified in section 6.5, Nature and contents of container. 2. In accordance with European Pharmacopoeia general monograph on parenteral products, which includes the requirements that “Parenteral products comply with the test for sterility’, the sterility test remains a requirement for all sterilized 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. 3. The sterility test must not be used to overturn any decision to reject a batch on parametric grounds. 4. The Irish Medicines Board (and
Marketing StatusNot marketed

Documents

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