Onpattro 2 mg/mL concentrate for solution for infusion *
Pharmacy Only: Prescription

  • Company:

    Alnylam UK Ltd.
  • Status:

    No Recent Update
  • 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 April 2023

File name

643676168f275.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

643675d3ef4bd.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

63c691302168d.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

63c690f264127.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_1640098811.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_1635778712.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 _1635778639.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_1635778598.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_1635778553.pdf

Reasons for updating

  • Add New Doc