SmPC - Hydrocortisone Accord 20mg Tablets (other registered names: hydrocortisone; hydrocortone; hitoden): Change history

Description of update:

1. IAIN, B.II.b.2.c.2 To replace Tiofarma BV with Accord-UK Ltd, Whiddon Valley, Barnstaple, Devon, EX32 8NS, United Kingdom as batch release and QC site.

2. IA, A7 To delete Tjoapack BV as primary and secondary packaging site; Tiofarma BV, Hermanus Boerhaavestraat 1, 3261 ME Oud-Beijerland, The Netherlands as batch release site; and Tiofarma BV, Benjamin Franklinstraat 5-10, 3261 LW Oud-Beijerland, The Netherlands as finished product manufacturer and packager.

3. IB, B.II.b.1.e To add Accord-UK Ltd Whiddon Valley, Barnstaple, Devon, EX32 8NS, United Kingdom, as a bulk manufacturing site

4. IAin, B.II.b.1.b To add Accord-UK Ltd Whiddon Valley, Barnstaple, Devon, EX32 8NS, United Kingdom, as a primary packaging site.

5. IAin, B.II.b.1.a To add Accord-UK Ltd Whiddon Valley, Barnstaple, Devon, EX32 8NS, United Kingdom, as a secondary packaging site.

6. IB, B.II.d.2.d To add a new Related Substances test procedure for the finished product.

7. IB, B.II.b.3.z To register updates to manufacturing process of the finished product to reflect Accord-UK as a manufacturer.

8. IB, B.II.b.5.z To register updates to IPCs of the finished product to reflect Accord-UK as a manufacturer.

9. IB, B.II.e.1.z To register 250μ PVC/20μ Al blister packaging for the finished product.

10. IB, B.II.a.3.b.6 To replace the excipient Maize Starch with Starch, pregelatinized, in the composition of the finished product. As a result, section 6.1 of the SPC has been updated.

11. IA, B.II.b.5.b To add an alternative IPC test and limit for blister integrity (Accord-UK Ltd method)

12. IB, B.II.a.3.z To remove brand name for the excipient Lactose (Sorbolac 400)

13. IB, B.II.a.3.z To remove brand name for the excipient Lactose (Flowlac 100)

14. IA, B.II.b.4.b To reduce the batch size of the finished product from 1,000,000 to 750, 000 tablets.

15. IB, B.II.b.3.z To extend the bulk holding time of the finished product from 90 days to 6 months.

16. IA, B.II.d.1.c To add ID by DAD to the FPS.

17. IB, B.II.d.2.d To add Microbiological Testing to the FPS.

18. IA, B.II.d.1.c To add Average Weight to the FPS.

19. IB, B.II.d.2.a To make changes to the Assay test for the finished product.

20. IB, B.II.d.2.a To make changes to the Dissolution test for the finished product.

21. IA, B.II.d.1.a To tighten Dissolution limits.

22. IA, B.II.b.2.a To add Lucideon Limited, Main Building, Queens Road, Stoke on-Trent, ST4 7LQ, United Kingdom, as a QC site (Microbiological testing) for the finished product.

SmPC Sections updated: 6.1 & 10.