Eucreas 50mg / 850mg and 50mg / 1000mg film-coated tablets
*Company:
Novartis Ireland LimitedStatus:
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 20 March 2024
File name
Eucreas REG_PIL_05.01.2024_PF24-009_New BRS site.docx.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
New batch release site
Updated on 24 August 2022
File name
Eucreas_REG PIL_PF22-148_07.07.2022_clean IPHA.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
New side effect added: blood vessel inflammation (vasculitis) which may result in skin rash or pointed, flat, red, round spots under the skin's surface or bruising.
Updated on 24 August 2022
File name
Eucreas_REG SPC_PF22-148_07.07.2022_IPHA.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Cutaneous vasculitis is added as an ADR with frequency “unknown”
Updated on 26 July 2022
File name
Eucreas_REG PIL_PF22-117_23.06.22 IPHA.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Change in frequency of some side effects
Updated on 26 July 2022
File name
Eucreas_REG SPC_PF21-117_23.06.2022_IPHA.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Changes to Section 4.8: ‘Abdominal pain renamed as ‘Abdominal pain, including upper. Skin reactions such as rash and dermatitis, were included with the frequency “common”
Updated on 06 July 2021
File name
Eucreas_REG PIL_PF 21-0164_June 2021_Clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - interactions with other medicines, food or drink
Updated on 06 July 2021
File name
Eucreas_REG SPC_PF 21-0164_June 2021_IPHA.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 02 September 2020
File name
EUCREAS REG PIL New R89 SKU and Lendava as BRS_May 2020.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - manufacturer
Updated on 15 June 2020
File name
Eucreas REG SPC PF20-112 May 2020 clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Approval of new triplex blister packs
Updated on 28 November 2019
File name
EUCREAS REG PIL Site Transfer September 2019.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 28 November 2019
File name
Galvus REG PIL PF18-073.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 28 November 2019
File name
EUCREAS REG PIL Site Transfer September 2019.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 02 April 2019
File name
Eucreas50-850mg+50-1000mg_REG_SmPC_PF18-0072_clean IPHA.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 October 2018
File name
EUCREAS_REG_PIL_2215784_R91_WEH_p1_LFT_X-4_IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 17 May 2018
File name
Eucreas50-850mg+50-1000mg_REG_SmPC_PF18-0072_clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 May 2018
File name
Eucreas50-850mg+50-1000mg_REG_SmPC_PF18-0072_clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 May 2018
File name
Eucreas50-850mg+50-1000mg_REG_SmPC_PF18-0072_clean.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 09 August 2017
File name
PIL_14275_792.pdf
Reasons for updating
- New PIL for new product
Updated on 09 August 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 06 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 April 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 11 April 2017
Reasons for updating
- Improved presentation of PIL
Updated on 30 August 2016
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 01 September 2015
Reasons for updating
- Change to side-effects
- Change to MA holder contact details
Updated on 19 June 2014
Reasons for updating
- Change to side-effects
Updated on 11 October 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to dosage and administration
Updated on 05 December 2012
Reasons for updating
- Change to, or new use for medicine
- Change to side-effects
Updated on 08 November 2012
Reasons for updating
- Change to side-effects
- Change to improve clarity and readability
Updated on 03 January 2012
Reasons for updating
- Change to warnings or special precautions for use
Updated on 18 August 2011
Reasons for updating
- Change to further information section
Updated on 22 September 2010
Reasons for updating
- Change to side-effects
Updated on 09 June 2010
Reasons for updating
- Change to MA holder contact details
Updated on 08 October 2009
Reasons for updating
- Change to side-effects
Updated on 05 May 2009
Reasons for updating
- New PIL for new product