When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Section 7 - MARKETING AUTHORISATION HOLDER
SPC Section 4.2 To update the paediatric dosage recommendation including the switch from body surface area (BSA)-based dosing (mg/m2) to body weight-based dosing (mg/kg), and the change from three times a day dosing to twice daily (BID) dosing.
SPC Section 4.2 + 5.2 To updated wording regarding administration and pharmacokinetics in patients with Renal impairment.
Change to section 1 - trade nameChange to section 2 - qualitative and quantitative composition
Change to section 4.2 - Posology and Method of AdministrationChange to section 4.3 - Contra-indicationsChange to section 4.4 - Special Warnings and Precautions for UseChange to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Change to section 4.7 Effects on ability to drive and use machines
Change to section 4.8 - Undesirable Effects
Change to section 5.2 – Pharmokinetic PropertiesChange to section 6.4 - Special Precautions for storageChange to section 9 – Date Of First Authorisation/Renewal Of The AuthorisationChange to section 10 - Date of (partial) revision of the text