KIOVIG 100 mg/ml solution for infusion
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 July 2022
File name
kiovig-spc-ie-TIB-0117-24Jun2022-clean.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 July 2022
File name
kiovig-pl-ie-mt-xi-TIB-0117-24Jun2022-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 04 January 2021
File name
kiovig-spc-ie-TIB-0099-11may2020-clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 May 2020
File name
kiovig-spc-ie-TIB-0099-11may2020-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 May 2020
File name
kiovig-pl-uk-ie-TIB-0099-may2020-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Change to dosage and administration
Updated on 20 November 2019
File name
Kiovig PI UK-IE-MT - Oct 2019 - Clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
The telephone number in the Patient Leaflet (Annex IIIB under “Marketing authorization holder”) has been updated from a UK number (+44(0)1256 894 959) to the International number + 800 66838470.
Updated on 20 November 2019
File name
Kiovig SmPC IE - 21 Oct 2019 - Clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Approval of the Transfer of Marketing Authorization Holder (MAH) from Baxter AG to Takeda Manufacturing Austria AG.
Updated on 06 September 2019
File name
UK-IE-MT-pl-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 23 August 2019
File name
UK-IE-MT-pl-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - how to report a side effect
Updated on 23 July 2019
File name
UK-IE-MT-pl-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
Updated on 12 March 2019
File name
Kiovig PIL UK-IE-MT-Feb2019-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
Updated on 06 March 2019
File name
PIL_16640_871.pdf
Reasons for updating
- Change to section 1 - what the product is used for
Updated on 21 February 2019
File name
PIL_16640_871.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - date of revision
Updated on 21 February 2019
File name
Kiovig SmPC IE-Feb2019-clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.2 - Incompatibilities
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to SmPC and Patient Leaflet (PL) to comply with the issuance by EMA of the new core SmPC for IVIgs that comes into effect on 1 January 2019.
This current SmPC revision includes also the inclusion of a new indication, chronic demyelinating polyradiculoneuropathy (CIDP).
Some misspelled words in English have also been corrected and make some minor editorial changes in several languages have been rectified.
Updated on 02 November 2018
File name
Kiovig SmPC IE Oct 2018.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of SmPC to implement a PRAC recommendation to include the lupus-like syndrome safety signal under 4.8. in the SmPC. Since clinical symptoms of cutaneous lupus erythematosus are already captured in the Patient Information Leaflet (PIL), section 4 of the package leaflet has not been updated.
Updated on 16 June 2017
File name
PIL_16640_871.pdf
Reasons for updating
- New PIL for new product
Updated on 16 June 2017
Reasons for updating
- Change to section 6 - date of revision
Updated on 15 February 2016
Reasons for updating
- New PIL for medicines.ie
Updated on 12 February 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)