KIOVIG 100 mg/ml solution for infusion
- Name:
KIOVIG 100 mg/ml solution for infusion
- Company:
Shire Pharmaceuticals Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 22/05/20
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Shire Pharmaceuticals Limited
Company Products
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 22 May 2020 SmPC
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 PIL
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 PIL
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 SmPC
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 6 September 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 23 August 2019 PIL
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 PIL
Reasons for updating
- Change to section 1 - what the product is used for
Updated on 12 March 2019 PIL
Reasons for updating
- Change to section 1 - what the product is used for
Updated on 6 March 2019 PIL
Reasons for updating
- Change to section 1 - what the product is used for
Updated on 21 February 2019 PIL
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 SmPC
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 2 November 2018 SmPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 16 June 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 15 February 2016 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 12 February 2016 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)