Onpattro 2 mg/mL concentrate for solution for infusion * Pharmacy Only: Prescription
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 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)
File name
2020-11-19-Onpattro-Educational Material for patients-IE-v1.0_1635778598.pdf
Reasons for updating
- Add New Doc
File name
2020-11-19-Onpattro-Educational Material for HCPs-IE-v1.0_1635778553.pdf
Reasons for updating
- Add New Doc