Onpattro 2 mg/mL concentrate for solution for infusion

*
Pharmacy Only: Prescription
  • Company:

    Alnylam UK Ltd.
  • Status:

    Updated
  • Legal 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 12 June 2024

File name

ema-combined-h-4699-en-IE-clean-SPC.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 12 June 2024

File name

ema-combined-h-4699-en-IE-clean-PIL.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 21 June 2023

File name

ema-combined-h-4699-clean_en_IE-onpattro-pil.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 21 June 2023

File name

ema-combined-h-4699-clean_en_IE-onpattro-smpc.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 12 April 2023

File name

Onpattro SmPC.pdf

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 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to restricted prescription (C)

Updated on 12 April 2023

File name

Onpattro PIL.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 17 January 2023

File name

SmPC-IE.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Global open‑label extension study addition of resuts

Updated on 17 January 2023

File name

PIL-IE.pdf

Reasons for updating

  • Change to section 6 - what the product contains

Free text change information supplied by the pharmaceutical company

Typographical error corrected

Updated on 21 December 2021

File name

2021-12-21-Onpattro II-22 - EN SmPC IE.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to restricted prescription (C)

Updated on 01 November 2021

File name

2020-11-20_ Shelf-life Address Pruritus_Onpattro EU PIL.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 November 2021

File name

2020-11-20_ Shelf-life Address Pruritus_Onpattro EU SmPC .pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to restricted prescription (C)

EDM Updated on 01 November 2021

File name

2020-11-19-Onpattro-Educational Material for patients-IE-v1.0.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 01 November 2021

File name

2020-11-19-Onpattro-Educational Material for HCPs-IE-v1.0.pdf

Reasons for updating

  • Add New Doc