Givlaari 189 mg/mL solution for injection
*Company:
Alnylam UK Ltd.Status:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 18 November 2024
File name
ema-combined-h-4775-IE-PIL.pdf
Reasons for updating
- Change to date of revision
Free text change information supplied by the pharmaceutical company
- Removal of black triangle (indication of additional safety monitoring)
Updated on 18 November 2024
File name
ema-combined-h-4775-IE-SmPC.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
- Removal of black triangle (indication of additional safety monitoring)
- Relocate of ‘Immunogenicity’ from section 4.8 to 5.1 (no new text added)
Updated on 29 June 2023
File name
ema-combined-h-4775-IE-SmPC.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Carcinogenicity rats
Updated on 12 May 2022
File name
Givlaari II-06 -PIL - clean - IE.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of a new adverse drug reaction (Blood homocysteine increased)
Updated on 12 May 2022
File name
Givlaari II-06 -SmPC - clean - IE.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Addition of a new adverse drug reaction (Blood homocysteine increased) with impact on section 4.4 Special warnings and precautions for use & 4.8 Undesirable effects
Updated on 01 November 2021
File name
givo pil.pdf
Reasons for updating
- New PIL for new product
Updated on 01 November 2021
File name
spc givo.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Alnylam UK Ltd.
Address:
Braywick Gate, Braywick Road, Maidenhead SL6 1DA, United KingdomMedical Information E-mail:
medinfo@alnylam.comMedical Information Facsimile:
+44 (0) 1255 444 400Medical Information Direct Line:
+44 1628878592