KIOVIG 100 mg/ml solution for infusion

  • Name:

    KIOVIG 100 mg/ml solution for infusion

  • Company:
    info
  • Active Ingredients:

    Human Normal Immunoglobulin

  • 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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Summary of Product Characteristics last updated on medicines.ie: 4/1/2021

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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Medicine Name Alofisel 5 million cells/mL suspension for injection Active Ingredients Human Allogeneic Mesenchymal Adult Stem Cells
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Medicine Name Calcichew-D3 Forte Chewable Tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Calcichew-D3 Forte Double Strength 1000 mg/800 IU chewable tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name CEPROTIN 1000 IU powder and solvent for solution for injection Active Ingredients Protein C
Medicine Name CEPROTIN 500 IU powder and solvent for solution for injection Active Ingredients Protein C
Medicine Name Cinryze 500 IU powder and solvent for solution for injection Active Ingredients C1 inhibitor (human)
Medicine Name Competact 15 mg/850 mg film-coated Tablets Active Ingredients Metformin Hydrochloride, pioglitazone hydrochloride
Medicine Name Condyline Cutaneous Solution 5 mg/ml Active Ingredients Podophyllotoxin
Medicine Name Cuvitru 200 mg/ml solution for subcutaneous injection Active Ingredients Human Normal Immunoglobulin
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Medicine Name Elaprase 2mg/ml concentrate for solution for infusion Active Ingredients Idursulfase
Medicine Name Entyvio 108 mg solution for injection in pre-filled syringe/pre-filled pen Active Ingredients Vedolizumab
Medicine Name Entyvio 300 mg powder for concentrate for solution for infusion Active Ingredients Vedolizumab
Medicine Name Equasym XL 10, 20 & 30mg Modified Release Capsules Active Ingredients Methylphenidate Hydrochloride
Medicine Name FEIBA 25 U/ml powder and solvent for solution for infusion Active Ingredients Factor VIII Inhibitor Bypassing Fraction
Medicine Name FEIBA 50 U/ml powder and solvent for solution for infusion Active Ingredients Factor VIII Inhibitor Bypassing Fraction
Medicine Name Firazyr 30 mg solution for injection in pre-filled syringe Active Ingredients Icatibant Acetate
1 - 0 of 62 items.Total: Infinity pages

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 4 January 2021 SPC

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 SPC

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 SPC

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 SPC

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 SPC

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 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)