SmPC- Ciprofloxacin 750mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Ciprofloxacin 750mg Film-coated Tablets)
Last updated on this site: 12 Aug 2024
IB C.I.2.a - To update sections 4.1, 4.2, 4.4, 4.5 & 5.1 of the SmPC and PIL in line with the reference product Ciprofloxacin 250mg /500mg/750mg film-coated Tablets in line with the reference product Ciproxin 250 mg/5 mL granules and solvent for oral suspension following assessment of the same change. In addition, section 4.2 and 4.5 headings have been updated in line with QRD, as well as typographical amends in 4.5.
IB C.I.3.a - To update section 5.1 of the SmPC in line with EMA request to include EUCAST location for MIC breakpoint data.
Last updated on this site: 12 Aug 2024
IB C.I.2.a - To update sections 4.1, 4.2, 4.4, 4.5 & 5.1 of the SmPC and PIL in line with the reference product Ciprofloxacin 250mg /500mg/750mg film-coated Tablets in line with the reference product Ciproxin 250 mg/5 mL granules and solvent for oral suspension following assessment of the same change. In addition, section 4.2 and 4.5 headings have been updated in line with QRD, as well as typographical amends in 4.5.
IB C.I.3.a - To update section 5.1 of the SmPC in line with EMA request to include EUCAST location for MIC breakpoint data.
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Changes: (Updated: 12 Aug 2024)
IB C.I.2.a - To update sections 4.1, 4.2, 4.4, 4.5 & 5.1 of the SmPC and PIL in line with the reference product Ciprofloxacin 250mg /500mg/750mg film-coated Tablets in line with the reference product Ciproxin 250 mg/5 mL granules and solvent for oral suspension following assessment of the same change. In addition, section 4.2 and 4.5 headings have been updated in line with QRD, as well as typographical amends in 4.5.
IB C.I.3.a - To update section 5.1 of the SmPC in line with EMA request to include EUCAST location for MIC breakpoint data.
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Changes: (Updated: 18 Mar 2024)
Description of update: To update SmPC sections 4.3, 4.4, 4.6, 4.8 and 5.1 in line with reference product Ciproxin 250 mg/5 mL granules and solvent for oral suspension. Consequently, the PIL has been updated. Additional updates:
Formatting updates to SmPC sections 4.3, 4.4, 4.8, 5.1 and PIL.
The tablet descriptions for all strengths in PIL section 6 have been updated in line with the wording in SmPC section 3.
QRD and editorial updates to the PIL.
SmPC Sections updated: 4.3, 4.4, 4.6, 4.8, 5.1 and 10.
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Changes: (Updated: 12 Jan 2024)
Description of update: To update sections 4.1, 4.4, 4.8 of the SPC and the PIL in line with the MHRA request entitled "Fluoroquinolone antibiotics: MHRA reviews of risk minimisation for disabling and potentially long-lasting or irreversible side effects and suicidal thoughts and behaviour", dated 18th September 2023. In addition, the section 4.4 of the SmPC and PIL has been updated in line with the excipient guideline, and editorial updates have been made to SmPC and PIL.
SmPC Sections updated: 4.1, 4.4, 4.8 and 10.
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Changes: (Updated: 24 Jul 2023)
To update sections 4.4 and 4.8 of the SmPC in line with the PSUSA Assessment (Doc. Ref.: PSUSA/00000775/201801 - published 21/01/2019) for Ciprofloxacin 250mg/500mg/750mg film-coated tablets. Consequently, the PIL has been updated
To update sections 4.1, 4.4 and 4.8 of the SmPC and PIL as per the recommendation of Article 31 for Quinolones and fluoroquinolones containing medicinal product (Ciprofloxacin) published on EMA.
To update section 4.4 of the SmPC in line with PRAC recommendations (Doc Ref: EMA/PRAC/595691/2018 - dated 01 October 2018) regarding the risk of aortic aneurysms and dissection after the intake of fluoroquinolones. As a consequence, the PIL has been updated.
To update sections 4.2, 4.4, 4.5, 4.8, 5.1 and 7 of the SmPC, in line with the reference product Ciproxin. As a consequence, the PIL has been updated with the changes.
To update sections 4.4 and 4.8 of the SmPC as per the wording agreed by PRAC recommendations. Consequently, the PIL has been updated.
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Changes: (Updated: 20 Sep 2022)
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