SmPC- Ibandronic acid Accord 3mg solution for injection in pre-filled syringe: Change history
View Summary of Product Characteristics (SmPC- Ibandronic acid Accord 3mg solution for injection in pre-filled syringe)
Last updated on this site: 21 Apr 2023
Description of update: To update section 4.8 of the SPC and section 4 of PIL in-line with PSUSA (EMEA/H/C/PSUSA/00001702/202106 published on EC) procedure outcome for Ibandronic acid Accord 1 mg/ml (3 mg) solution for injection in pre-filled syringe.
SmPC sections updated: 4.8, 10.
View Summary of Product Characteristics (SmPC- Ibandronic acid Accord 3mg solution for injection in pre-filled syringe)
Last updated on this site: 21 Apr 2023
Description of update: To update section 4.8 of the SPC and section 4 of PIL in-line with PSUSA (EMEA/H/C/PSUSA/00001702/202106 published on EC) procedure outcome for Ibandronic acid Accord 1 mg/ml (3 mg) solution for injection in pre-filled syringe.
SmPC sections updated: 4.8, 10.
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Changes: (Updated: 21 Apr 2023)
Description of update: To update section 4.8 of the SPC and section 4 of PIL in-line with PSUSA (EMEA/H/C/PSUSA/00001702/202106 published on EC) procedure outcome for Ibandronic acid Accord 1 mg/ml (3 mg) solution for injection in pre-filled syringe.
SmPC sections updated: 4.8, 10.
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Changes: (Updated: 22 Sep 2022)
initial upload