SmPC - Orgovyx® 120 mg film-coated tablets, Relugolix 120 mg film-coated tablets (Great Britain): Change history

CCC-AccordUK-00142-017

IB grouped variation via IRP route:

1.) IB, B.II.e.1.b.1 – Register a change in the immediate packaging of the finished product; addition of a new container 30's count blister pack with shelf life of 48 months.

2.) IB, B.II.e.1.b.1 – Register a change in the immediate packaging of the finished product; addition of a new container 90's count blister pack with shelf life of 48 months.

3.) IAin, B.II.e.5.a.1 – Register addition of a new pack size of 90's

HDPE bottle.

4.) IA, B.II.b.5.b – Register addition of blister leak test as a new in-process test applied during the manufacture of the finished product.

5.) IB, B.II.f.1.b.1 – Register an extension to the shelf life of the HDPE bottle for the finished product as packed for sale from 36 months to 48 months when stored below 30˚C.