PIL - Methofill 50mg/ml Solution for Injection in Pre-filled Syringe: Change history

Last updated on this site: 27 Jun 2024

Update to SmPC section 6.5 and leaflet section 6 to remove without blister packaging details

Changes: (Updated: 27 Jun 2024)

Update to SmPC section 6.5 and leaflet section 6 to remove without blister packaging details
Changes: (Updated: 12 Feb 2024)

Description of update: Variation type IA: A.5.b - Change in the name of Batch control/testing site from Wessling Hungary Kft., Anonymus utca 6., Budapest H-1045, Hungary to Eurofins Analytical Services Hungary Kft., Anonymus utca 6, Budapest, 1045, Hungary. A.7 - The deletion of Wessling Hungary Kft. Anonymus utca 6, Budapest, H-1045, Hungary as Batch release site.
PIL sections updated: 6 only.
Changes: (Updated: 18 Dec 2023)

Description of update: Type IB (C.I.3.a) variation application to update section 4.6 of SmPC and to update section 2 of PIL in-line with the agreed wording of PSUFU (DE/H/PSUFU/00002014/202110) for Injexate 50 mg/ml solution for injection in pre-filled syringe.
PIL sections updated: 2 and 6.
Changes: (Updated: 20 Sep 2022)

Linked to amended product entry
Changes: (Updated: 15 Sep 2022)

Added document ID
Changes: (Updated: 12 Sep 2022)

Initial upload

Changes: (Updated: 27 Jun 2024)