PIL - Mitoxantrone 2mg/ml concentrate for solution for infusion: Change history
View Patient Information Leaflet (PIL - Mitoxantrone 2mg/ml concentrate for solution for infusion)
Last updated on this site: 29 Jul 2024
To update SmPC in-line with information of reference product (Novantrone 2 mg/ml concentrate for solution for infusion).
Additionally, applicant has updated SmPC with editorial changes and QRD template related changes.
Last updated on this site: 29 Jul 2024
To update SmPC in-line with information of reference product (Novantrone 2 mg/ml concentrate for solution for infusion).
Additionally, applicant has updated SmPC with editorial changes and QRD template related changes.
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Changes: (Updated: 29 Jul 2024)
To update SmPC in-line with information of reference product (Novantrone 2 mg/ml concentrate for solution for infusion).
Additionally, applicant has updated SmPC with editorial changes and QRD template related changes.
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Changes: (Updated: 15 Jan 2024)
Description of update: To update section 4.4 and 4.6 of SmPC and section 2 of PIL according to SWP recommendations on the duration of contraception following the end of treatment with a genotoxic drug. Calculations are taken over from Novantron 10 mg/5 ml, DE/H/4808/002 (MAH: Viatris Healthcare GmbH, Germany).
PIL sections updated: 2, 3 & 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload