SmPC - Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion: Change history
View Summary of Product Characteristics (SmPC - Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion)
Last updated on this site: 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).
SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 6.6 and 10.
Last updated on this site: 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).
SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 6.6 and 10.
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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).
SmPC sections updated: 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 5.3, 6.6 and 10.
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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.
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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).
SmPC sections updated: 4.4, 5.1, 5.2.
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Changes: (Updated: 07 Jun 2023)
Website administration update - no change to content
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Changes: (Updated: 09 Nov 2022)
Updated
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Changes: (Updated: 20 Sep 2022)
Initial upload