Minocin SA 100 mg Modified Release Capsules
*Company:
Mylan IRE Healthcare LtdStatus:
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 25 September 2023
File name
ie-pl-minocin-pr3176130-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 25 September 2023
File name
ie-spc-minocin-pr3176130-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 September 2023
File name
ie-spc-minocin-pr3176130-clean.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 March 2022
File name
ie-pl-minocin-pr2647684-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 29 September 2020
File name
ie-spc-minocin-pr1656850-clean.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 September 2020
File name
ie-pl-minocin-pr1656850-clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 18 December 2019
File name
ie-spc-minocin-pr1940162-clean.pdf
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 not be renewed (A)
Updated on 13 February 2019
File name
ie-pl-minocin-mahtransfer-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 12 February 2019
File name
ie-spc-minocin-mahtransfer-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 June 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 June 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In Section 4.8 : ADR statement has been added
In Section 10 : Date of revision is changed
In Section 10 : Date of revision is changed
Updated on 25 June 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In Section 4.8 : ADR statement has been added
In Section 10 : Date of revision is changed
In Section 10 : Date of revision is changed
Updated on 09 May 2013
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
· In section 6.3: the shelf-life has been increased from 18 months to 24 months
· In section 10: the date of revision has changed
Updated on 09 May 2013
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
· In section 6.3: the shelf-life has been increased from 18 months to 24 months
· In section 10: the date of revision has changed
Updated on 27 April 2012
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 3; the description of the pellets have changes
in section 10; the date of revision has changes
in section 10; the date of revision has changes
Updated on 27 April 2012
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 3; the description of the pellets have changes
in section 10; the date of revision has changes
in section 10; the date of revision has changes
Updated on 07 March 2011
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 7: the change of the MAH has changed
In section 10: the date of revison has changed to Feb 2011
In section 10: the date of revison has changed to Feb 2011
Updated on 07 March 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 7: the change of the MAH has changed
In section 10: the date of revison has changed to Feb 2011
In section 10: the date of revison has changed to Feb 2011
Updated on 22 December 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 2; reference to the soya content as a component of the printing ink has been removed
In section 3: reference to the ink on the capusle has been removed
In section 6.1: the excipients for the ink have been removed as there is no longer ink embossing on the capsules
In section 10: the date of revision has been changed to September 2008
In section 3: reference to the ink on the capusle has been removed
In section 6.1: the excipients for the ink have been removed as there is no longer ink embossing on the capsules
In section 10: the date of revision has been changed to September 2008
Updated on 22 December 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 2; reference to the soya content as a component of the printing ink has been removed
In section 3: reference to the ink on the capusle has been removed
In section 6.1: the excipients for the ink have been removed as there is no longer ink embossing on the capsules
In section 10: the date of revision has been changed to September 2008
In section 3: reference to the ink on the capusle has been removed
In section 6.1: the excipients for the ink have been removed as there is no longer ink embossing on the capsules
In section 10: the date of revision has been changed to September 2008
Updated on 28 August 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2
First sentence revised to read 'Each capsule contains 100mg of minocycline (equivalent to 116mg of minocycline hydrochloride as the dehydrate salt).'
Section 4.5
Updated in line with company prescribing information to include interaction with sytemic retinol and other systemic retinoids
Section 4.8
Updated in line with company prescribing information to include tooth discolouration as an adverse event.
Updated on 28 August 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Section 2
First sentence revised to read 'Each capsule contains 100mg of minocycline (equivalent to 116mg of minocycline hydrochloride as the dehydrate salt).'
Section 4.5
Updated in line with company prescribing information to include interaction with sytemic retinol and other systemic retinoids
Section 4.8
Updated in line with company prescribing information to include tooth discolouration as an adverse event.
Updated on 16 August 2005
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 August 2005
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Updated on 16 November 2004
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 November 2004
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
Updated on 25 May 2004
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 May 2004
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Updated on 20 November 2003
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 November 2003
Reasons for updating
- Change to section 4.8 - Undesirable effects
Updated on 10 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 June 2003
Reasons for updating
- New SPC for medicines.ie