Phorpain 5% w/w Gel
*Company:
ADVANZ PharmaStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 28 May 2021
File name
Phorpain 5 ww Gel_PIL_IE.pdf
Reasons for updating
- New PIL for new product
Updated on 28 May 2021
File name
Phorpain 5 ww Gel_SPC_IE.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
update SmPC section 4.8 and PIL sections 4 in line with the recommendation received from CMDh with the scientific conclusion made by the PRAC.
Updated on 21 April 2020
File name
200416 SPC.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
A National Type IB variation application change code C.I.z to update the PIL as a result of successful user testing of PIL for aforesaid product.
Note: As a part of RFI response we have updated SPC section 4.6 based on the authority suggestion.
4.6 Updated and includes "Not to be used during pregnancy or lactation."
Updated on 29 May 2019
File name
1.3.1 SPC-IE-English.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)