Erwinase 10 000 U powder for solution for injection/infusion
*Company:
Porton Biopharma LimitedStatus:
UpdatedLegal 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 10 December 2025
File name
Erwinase Ireland_GB SmPC September 2025.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to Section 7 update to MAH address, Change to Section 9 to include date of latest renewal
Updated on 10 December 2025
File name
Erwinase Ireland_GB PIL September 2025.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Change to Section 6 update to Marketing Authorisation Holder (MAH) address
Updated on 21 April 2022
File name
IE Erwinase SmPC_09 Mar 2022.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 April 2022
File name
IE Erwinase PIL_09 Mar 2022.pdf
Reasons for updating
- New PIL for new product
Updated on 21 April 2022
File name
IE Erwinase SmPC_clean_09 Mar 2022.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 April 2022
File name
IE Erw SmPC_clean_Approved 09 Mar 2022.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Porton Biopharma Limited
Address:
Porton Biopharma Limited, MC2, Penrose Wharf Business Centre, Penrose Quay, Cork T23 XN53, IrelandMedical Information E-mail:
medinfo@portonbiopharma.comTelephone:
+353 (0) 21 237 6037Medical Information Direct Line:
+44 1980 745 022Customer Care direct line:
+44 1980 745 022