PIL - Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion: Change history
View Patient Information Leaflet (PIL - Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion)
Last updated on this site: 13 May 2024
Description of update:
Type IA: B.III.1.a.2 - to update European Pharmacopoeia certificate of suitability (R0-CEP 2017-147- Rev 00 to R0-CEP 2017-147- Rev 01) from already approved manufacturer i.e., Shilpa Pharma Lifesciences Limited.
Type IA: B.III.1.a.2 - to update European Pharmacopoeia certificate of suitability (R0-CEP 2017-147- Rev 01 to R1-CEP 2017-147- Rev 00) from already approved manufacturer i.e., Shilpa Pharma Lifesciences Limited.
Type IA: A.7. - to delete Accord Healthcare B.V., Netherland as Batch release site.
PIL sections updated: 6 only.
No changes to SmPC.
Last updated on this site: 13 May 2024
Description of update:
Type IA: B.III.1.a.2 - to update European Pharmacopoeia certificate of suitability (R0-CEP 2017-147- Rev 00 to R0-CEP 2017-147- Rev 01) from already approved manufacturer i.e., Shilpa Pharma Lifesciences Limited.
Type IA: B.III.1.a.2 - to update European Pharmacopoeia certificate of suitability (R0-CEP 2017-147- Rev 01 to R1-CEP 2017-147- Rev 00) from already approved manufacturer i.e., Shilpa Pharma Lifesciences Limited.
Type IA: A.7. - to delete Accord Healthcare B.V., Netherland as Batch release site.
PIL sections updated: 6 only.
No changes to SmPC.
-
Changes: (Updated: 13 May 2024)
Description of update:
Type IA: B.III.1.a.2 - to update European Pharmacopoeia certificate of suitability (R0-CEP 2017-147- Rev 00 to R0-CEP 2017-147- Rev 01) from already approved manufacturer i.e., Shilpa Pharma Lifesciences Limited.
Type IA: B.III.1.a.2 - to update European Pharmacopoeia certificate of suitability (R0-CEP 2017-147- Rev 01 to R1-CEP 2017-147- Rev 00) from already approved manufacturer i.e., Shilpa Pharma Lifesciences Limited.
Type IA: A.7. - to delete Accord Healthcare B.V., Netherland as Batch release site.
PIL sections updated: 6 only.
No changes to SmPC.
-
Changes: (Updated: 07 Nov 2023)
Description of update:
To bring SmPC and PIL in line with the information of reference product (CAMPTO 20 mg/mL concentrate for solution for infusion, Pfizer Healthcare, FR/H/0108/002).
PIL sections updated: Introduction, 1, 2 3 and 6.
-
Changes: (Updated: 21 Aug 2023)
Description of update: NL/H/4565/001/IB/016 to update SmPC and PIL information in-line with the product information of the reference product (CAMPTO 20 mg/mL concentrate for solution for infusion, EU Procedure number: FR/H/0108/001: Pfizer Healthcare Ireland, Ireland)
No further change to file.
-
Changes: (Updated: 17 Aug 2023)
Description of update: Type IB (C.I.3.a) To update section 4.4, 5.1 and 5.2 of SmPC and section 2 of PIL in-line with the agreed wording of PSUFU outcome (FR/H/PSUFU/00001783/202005).
PIL section/s updated: 2.
-
Changes: (Updated: 07 Jun 2023)
Website administration update - no change to content
-
Changes: (Updated: 21 Oct 2022)
Update
-
Changes: (Updated: 21 Sep 2022)
Initial upload