SmPC - Pemetrexed Accord 25 mg/ml concentrate for solution for infusion: Change history
View Summary of Product Characteristics (SmPC - Pemetrexed Accord 25 mg/ml concentrate for solution for infusion)
Last updated on this site: 01 Oct 2025
To register the addition of the new Ph. Eur. Certificate of Suitability (R0-CEP 2020-336 - Rev 01) for Pemetrexed Disodium of new active substance manufacturer i.e. MSN Laboratories Private Limited,responsible for manufacturing and testing of Pemetrexed Disodium active substance used in the manufacture of Pemetrexed Accord 25 mg/ml concentrate for solution for infusion. This certificate supports a conditional retest period of 60 months.
Last updated on this site: 01 Oct 2025
To register the addition of the new Ph. Eur. Certificate of Suitability (R0-CEP 2020-336 - Rev 01) for Pemetrexed Disodium of new active substance manufacturer i.e. MSN Laboratories Private Limited,responsible for manufacturing and testing of Pemetrexed Disodium active substance used in the manufacture of Pemetrexed Accord 25 mg/ml concentrate for solution for infusion. This certificate supports a conditional retest period of 60 months.
-
Changes: (Updated: 01 Oct 2025)
To register the addition of the new Ph. Eur. Certificate of Suitability (R0-CEP 2020-336 - Rev 01) for Pemetrexed Disodium of new active substance manufacturer i.e. MSN Laboratories Private Limited,responsible for manufacturing and testing of Pemetrexed Disodium active substance used in the manufacture of Pemetrexed Accord 25 mg/ml concentrate for solution for infusion. This certificate supports a conditional retest period of 60 months.
-
Changes: (Updated: 09 Apr 2025)
To submit Type IAIN (C.I.3.a) variation to update section 4.5 of the SmPC and leaflet section 2 of the PL to implement the wording agreed by the CHMP following outcome of the PSUR procedure (EMEA/H/C/PSUSA/00002330/202402) for Pemetrexed.
-
Changes: (Updated: 09 Nov 2022)
Initial upload