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