Ultomiris 300mg/3ml

  • Name:

    Ultomiris 300mg/3ml

  • Company:
    info
  • Active Ingredients:

    Ravulizumab

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/11/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 23/11/2020
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Alexion Pharma UK Ltd

Alexion Pharma UK Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Kanuma Active Ingredients Sebelipase alfa
Medicine Name Soliris Active Ingredients Eculizumab
Medicine Name Strensiq 100mg/ml Active Ingredients Asfotase alfa
Medicine Name Strensiq 40mg/ml Active Ingredients Asfotase alfa
Medicine Name Ultomiris 1100mg/11ml Active Ingredients Ravulizumab
Medicine Name Ultomiris 300mg/30ml Active Ingredients Ravulizumab
Medicine Name Ultomiris 300mg/3ml Active Ingredients Ravulizumab
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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 23 November 2020 PIL

Reasons for updating

  • XPIL Created

Free text change information supplied by the pharmaceutical company

New XPIL for 300mg/3ml has been created following EMA approval on 18 Nov 2020.

Updated on 23 November 2020 PIL

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

New PIL for 300mg/3ml has been created following EMA approval on 18 Nov 2020.

Updated on 23 November 2020 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

On 18 November 2020 EMA issued an approval for the addition of new 100mg/ml strength (3ml and 11ml). 

The following SmPC sections have been updated to reflect this change:

1.            NAME OF THE MEDICINAL PRODUCT

2.            QUALITATIVE AND QUANTITATIVE COMPOSITION (new formulation of 100mg/ml)

3.            PHARMACEUTICAL FORM

4.            CLINICAL PARTICULARS

  •  Section 4.2 Posology and method of administration
  •  Section 4.4 Special warnings and precautions for use: Sodium content

5.                PHARMACOLOGICAL PROPERTIES

  • Section 5.1 Pharmacodynamic properties

6.            PHARMACEUTICAL PARTICULARS

  • Section 6.1 List of excipients (100mg/ml only)
  • Section 6.3 Shelf life (100mg/ml only)
  • Section 6.5 Nature and contents of container
  • Section 6.6 Special precautions for disposal a d other handling

8.            MARKETING AUTHORISATION NUMBER(S)

10.          DATE OF REVISION OF THE TEXT