SmPC - Ondansetron 2mg/ml solution for injection or infusion: Change history
View Summary of Product Characteristics (SmPC - Ondansetron 2mg/ml solution for injection or infusion)
Last updated on this site: 18 Apr 2023
Variation update: To update sections 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC in line with the Product information of reference product information (Zofran 4/8 Injectie, oplossing voor injectie 2 mg/ml; Procedure number: RVG 14292, RVG 14293 MAH: Novartis Pharma B.V., Netherlands) for Ondansetron 2mg/ml Solution for Injection or Infusion. Consequentially, the PIL has been updated.
SmPC sections updated: 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 10.
PIL sections updated: 1, 2, 3, 4, 6.
Last updated on this site: 18 Apr 2023
Variation update: To update sections 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC in line with the Product information of reference product information (Zofran 4/8 Injectie, oplossing voor injectie 2 mg/ml; Procedure number: RVG 14292, RVG 14293 MAH: Novartis Pharma B.V., Netherlands) for Ondansetron 2mg/ml Solution for Injection or Infusion. Consequentially, the PIL has been updated.
SmPC sections updated: 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 10.
PIL sections updated: 1, 2, 3, 4, 6.
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Changes: (Updated: 18 Apr 2023)
Variation update: To update sections 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC in line with the Product information of reference product information (Zofran 4/8 Injectie, oplossing voor injectie 2 mg/ml; Procedure number: RVG 14292, RVG 14293 MAH: Novartis Pharma B.V., Netherlands) for Ondansetron 2mg/ml Solution for Injection or Infusion. Consequentially, the PIL has been updated.
SmPC sections updated: 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 10.
PIL sections updated: 1, 2, 3, 4, 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload