KIOVIG 100 mg/ml solution for infusion *

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 04 January 2021

File name

kiovig-spc-ie-TIB-0099-11may2020-clean_1609780306.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_1590162264.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_1590161978.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_1574258455.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_1574258342.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_1567756917.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 23 August 2019

File name

UK-IE-MT-pl-clean_1566556106.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_1563809823.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_1552384785.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_1550757331.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_1541172882.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)