Abilify Maintena pre-filled syringe 400mg (300mg not marketed)
- Name:
Abilify Maintena pre-filled syringe 400mg (300mg not marketed)
- Company:
Lundbeck (Ireland) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/11/20

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Lundbeck (Ireland) Limited
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Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 4 November 2020 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 4 November 2020 PIL
Reasons for updating
- Change to section 3 - how to take/use
Updated on 20 October 2020 SPC
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 October 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 15 May 2020 SPC
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 15 May 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 13 May 2020 SPC
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 13 May 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 12 August 2019 PIL
Reasons for updating
- Change to information for healthcare professionals
Updated on 20 May 2019 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 7 May 2019 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 6 May 2019 SPC
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 21 November 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to MA holder contact details
Updated on 6 November 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 6 November 2018 SPC
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
The amendment is a change to the MA holder address in Section 7.
New address as follows:
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands
Updated on 5 November 2018 SPC
Reasons for updating
- 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
The address of the Marketing Authorisation holder has been amended to:
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands
Updated on 27 September 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 14 September 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 14 September 2018 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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
The following changes have been made due to the 5 year licence renewal. In the main these are formatting changes,
Section 4.2: Revision of text on missed doses
Section 4.4: Addition of Sodium Statement as follows: "Abilify Maintena contains less than 1 mmol of sodium (23 mg) per dose."
Section 6.3: Addition of existing reconstitution text from section 2
Section 6.5: More detailed description of contents of container
Section 6.6: Moving of existing text from Carton to Section 6.6
Updated on 13 May 2018 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 4 May 2018 PIL
Reasons for updating
- New individual PIL (was previously included in a combined PIL)
Updated on 3 April 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 3 April 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 April 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 3 April 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 April 2018 SPC
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)
Free text change information supplied by the pharmaceutical company
Updated on 18 July 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 18 July 2016 SPC
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)
Free text change information supplied by the pharmaceutical company
Updated on 1 July 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 1 July 2016 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
- Addition of joint PIL covering all presentations
Updated on 20 July 2015 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Text regarding prolactin blood levels have been moved from seciton 4.8 to 5.1
Date of revision of the text has been updated.
Updated on 16 July 2015 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 14 May 2015 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updated on 12 May 2015 PIL
Reasons for updating
- Change to packaging
- Change to, or new use for medicine
- Change to side-effects
- Change to date of revision
- Correction of spelling/typing errors
Updated on 22 December 2014 SPC
Reasons for updating
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Deletion of multipack from section 6.5
Updated on 1 October 2014 PIL
Reasons for updating
- New PIL for new product
Updated on 30 September 2014 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)