Business process review: minor variations to prescription medicines - for sponsors
On 22 May 2013 the TGA will introduce changes to administrative processes for making minor variations to prescription medicines
Undefined
On 22 May 2013 the TGA will introduce changes to administrative processes for making minor variations to prescription medicines
Updated information for Appendix 12 and Appendix 13
Incorrect test results at extremely high blood glucose levels.
L’ Agenzia Italiana del Farmaco, in accordo con l’Agenzia Europea dei
Medicinali (EMA), rende disponibile on line nuove ed importanti
informazioni sul potenziale rischio di danno epatico associato a Samsca® (tolvaptan).
Draft compositional guideline for Squid Oil. Closing date: 1 July 2013
Added two products cancelled from the ARTG following compliance review
If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection.
Patients are at increased risk of infection in the event a sterile product is compromised.
L'Agenzia Europea dei Medicinali ha avviato una rivalutazione sull’uso concomitante di medicinali che agiscono sul sistema renina–angiotensina (RAS).
Il Pharmacovigilance Risk Assessment Committee (PRAC) dell’EMA ha concluso che i benefici di Diane 35 (ciproterone acetato 2 mg ed etinilestradiolo 35 microgrammi) ed i suoi generici superano i rischi, in alcuni gruppi di pazienti.
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