Vesitirim 1 mg/ml oral suspension
*Company:
Astellas Pharma Co. LtdStatus:
No Recent UpdateLegal 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)