Ultomiris 1100mg/11ml
- Name:
Ultomiris 1100mg/11ml
- Company:
Alexion Pharma UK Ltd
- Active Ingredients:
- Legal Category:
Product subject to restricted prescription (C)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/11/20
(Click to Download)XPIL
1. What Ultomiris is and what it is used for
1. What Ultomiris is and what it is used for
2. What you need to know before you use Ultomiris
2. What you need to know before you use Ultomiris
3. How to use Ultomiris
3. How to use Ultomiris
4. Possible side effects
4. Possible side effects
5. How to store Ultomiris
5. How to store Ultomiris
6. Contents of the pack and other information
6. Contents of the pack and other information
Instructions for Use for Healthcare Professionals Handling Ultomiris
Instructions for Use for Healthcare Professionals Handling Ultomiris
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Alexion Pharma UK Ltd
Company Products
| Medicine Name | Active 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 |
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
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for 1100mg/11ml 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 11 ml). 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