Erelzi 50 mg solution for injection in pre-filled pen
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 December 2023
File name
Erelzi 50mg PFP_REG SPC_PF23-0213_19.12.2023_clean_IPHA.pdf
Reasons for updating
- 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 5.2 - Pharmacokinetic properties
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 December 2023
File name
Erelzi 50mg PFP_REG PIL_PF23-0213_19.12.23_clean_IPHA.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to name of manufacturer
- Change to dosage and administration
File name
IE_Erelzi_Patient Card_RMP_FINAL HPRA APPROVED_VF_Oct 2021.pdf
Reasons for updating
- Add New Doc
Updated on 27 July 2023
File name
Erelzi 50mg PFP_REG PIL_QR code added_07 2022_clean.pdf
Reasons for updating
- Change to dosage and administration
Updated on 07 November 2022
File name
Erelzi 50mg PFP_REG PIL_07 2022_clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 20 October 2022
File name
Erelzi 50mg PFP_REG SPC_09 2022_clean_IPHA.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 September 2022
File name
Erelzi 50mg PFP_REG SPC_08 2022_clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 September 2022
File name
Erelzi 50mg PFP_REG PIL_08 2022_clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 12 July 2022
File name
Erelzi 50mg PFP_REG SPC_04.2022_clean.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Improved presentation of SPC
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 July 2022
File name
Erelzi 50mg PFP_REG PIL_April 2022_clean.pdf
Reasons for updating
- New PIL for new product
Updated on 03 March 2022
File name
Erelzi 50mg Solution for Injection in Prefilled Pen.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)