Givlaari 189 mg/mL solution for injection

*
Pharmacy Only: Prescription
  • Company:

    Alnylam UK Ltd.
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to restricted prescription (C)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

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)