Vesitirim 1 mg/ml oral suspension

*
Pharmacy Only: Prescription
  • Company:

    Astellas Pharma Co. Ltd
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 04 April 2024

File name

Vesitirim OS_PIL_IE_1Apr2024_cl.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 19 September 2023

File name

Vesitirim OS_SPC_IE_14Sep2023_clean.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Correction of spelling/typing errors
  • Improved presentation of SPC

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 19 September 2023

File name

Vesitirim OS_PIL_IE_Sep2023_clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 07 December 2022

File name

IE_Vesitirim OS_SmPC_Dec2022.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 December 2022

File name

IE_Vesitirim OS_SmPC_Dec2022.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change of address of the MAH Astellas Pharma Co., Ltd.

Updated on 05 December 2022

File name

IE_Vesitirim OS_PIL_Dec2022.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

Change of address of the MAH Astellas Pharma Co., Ltd.

Updated on 07 October 2022

File name

IE_Vesitirim OS_SmPC_Oct2022_cl.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Extension shelf-life from 2 to 3 years

Updated on 08 October 2021

File name

IE_Vesitirim OS_SmPC_Jul 2021_cl.pdf

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 30 September 2021

File name

IE_Vesitirim OS_PIL_Jul 2021_cl.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 29 July 2021

File name

IE_Vesitirim OS_SmPC_Jul 2021_cl.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 29 July 2021

File name

IE_Vesitirim OS_PIL_Jul 2021_cl.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 November 2019

File name

Vesitirim OS_SmPC_Oct 2019_cl.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 16 October 2018

File name

IE_Vesitirim oral susp_en_08-Feb-18_PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 15 October 2018

File name

LFT 154229.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 12 October 2018

File name

LFT 154229.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 October 2018

File name

IE_Vesitirim oral susp_Feb-18_SmPC.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)