Efracea capsules
*Company:
Galderma International S.A.S. c/o Galderma (U.K) Ltd.Status:
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 14 November 2022
File name
ie-spc-3November2022-v2-clean.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 26 October 2022
File name
ie-spc-24October2022-v2-clean.pdf
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 26 October 2022
File name
ie-ni-text-pl-24October2022-v2-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 15 August 2022
File name
ie-ni-mockup-pl-April2022-v1-P201416-0-clean.pdf
Reasons for updating
- XPIL Updated
Updated on 27 June 2022
File name
ie-ni-mockup-pl-April2022-v1-P201416-0-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to date of revision
Updated on 17 March 2022
File name
ie-spc-11May2021-v1-clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 24 February 2022
File name
Efracea_PIL_UK__IRE_V14_(P28227-1)-vertical.pdf
Reasons for updating
- XPIL Updated
Updated on 28 May 2021
File name
ie-spc-clean-11May2021.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 September 2020
File name
Efracea_PIL_UK__IRE_V14_(P28227-1)-vertical.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 09 February 2020
File name
ie-spc-current-Efracea-Jan20.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
- File format updated to PDF
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 04 December 2017
File name
PIL_14729_220.pdf
Reasons for updating
- New PIL for new product
Updated on 04 December 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 13 April 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 April 2016
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 April 2016
Reasons for updating
- Change to drug interactions
Updated on 03 December 2014
Reasons for updating
- Addition of manufacturer
Updated on 02 December 2014
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
Updated on 15 May 2014
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
Updated on 16 April 2014
Reasons for updating
- Change to side-effects
- Addition of information on reporting a side effect.
Updated on 01 April 2014
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 medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 11 July 2012
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 July 2012
Reasons for updating
- Change to name of manufacturer
- Introduction of new pack/pack size
Updated on 03 November 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.3 - Additoin of "Concomitant treatment with oral retinoids due to the risk of increased intracranial pressure (See section 4.5).
Section 4.4 - Confirmation that Efracea yields anti-inflammatory plasma levels added to boxed text
Section 4.6 - Addition of "Oral administration of doxycycline to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance (see section 5.3). The effect of EFRACEA on human fertility is unknown."
Section 4.8 - Addition of "Benign intracranial hypertension and headache (unknown frequency: cannot be estimated from the available data) have been reported during EFRACEA postmarketing surveillance."
Section 6.1 - Deleted 3cP/6cP from Hypromellose
Updated on 25 October 2011
Reasons for updating
- Change of inactive ingredient
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 23 June 2010
Reasons for updating
- New PIL for new product
Updated on 22 June 2010
Reasons for updating
- New SPC for new product
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)