ABILIFY 5 mg, 10 mg, 15 mg and 30 mg tablets *

  • Company:

    Otsuka Pharmaceutical UK Ltd.
  • Status:

    No Recent Update
  • Legal 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

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 20 October 2020

File name

Abilify Tablets PIL- Ireland_1603185529.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Update of Common side effects: akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),

Uncommon side effects: restless legs,

Frequency not known side effects:

• serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).

Updated on 20 October 2020

File name

Abilify Tablets SPC- Ireland_1603185314.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

Update of “Restless legs syndrome” under the frequency “Uncommon”

Update of “Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)” under the frequency “Not known”

Updated on 05 May 2020

File name

Abilify tablets PIL - Ireland_1588697442.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 4 Possible side effects:
-          Uncommon side effects (may affect up to 1 in 100 people): the wording ‘eye sensitivity to light’ has been added

-          The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known: the wording ‘sensitivity to light’ has been replaced by ‘skin sensitivity to light’

Updated on 05 May 2020

File name

Abilify tablets SPC- Ireland_1588697164.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

Section 4.8 Undesirable effects: Eye disorders- Uncommon section
‘Photophobia’ has been added

Updated on 28 October 2019

File name

Abilify tablets Sodium update - PIL IE_1571670428.pdf

Reasons for updating

  • XPIL Updated

Free text change information supplied by the pharmaceutical company

Update of the XPIL

Updated on 21 October 2019

File name

Abilify tablets Sodium update - PIL IE_1571670428.pdf

Reasons for updating

  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Minor editorial changes made to section 2 and section 6.

Updated on 21 October 2019

File name

Abilify tablets Sodium update - SPC Ireland_1571648075.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

Section 4.6: wording added 'aripiprazole metabolites' on breastfeeding.

Section 4.8: reclassification of a number of adverse events to 'Investigations'. Editorial changes made.

 

Updated on 13 May 2019

File name

Abilify MAH change tablets -PIL IE_1544523645.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 13 May 2019

File name

Abilify Tablets SmPC Ireland_1557756305.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 2: addition of 'as monohydrate' to tablet lactose composition

Section 4.4: addition of precaution for 'falls'

Section 4.8: oculogyric crisis listed as not known

Updated on 13 May 2019

File name

Abilify Tablets SmPC Ireland_1557755841.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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

Section 4.4: addition of 'falls' as a warning and precaution

Section 4.8: addition of oculogyric crisis is listed under not known

Updated on 11 December 2018

File name

Abilify MAH change tablets -PIL IE_1544523645.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 11 December 2018

File name

Abilify tablets MAH change SPC IE_1544522047.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7. Change of Marketing Authorisation Holder (MAH) from Otsuka Pharmaceutical Europe Ltd. to Otsuka Pharmaceutical Netherlands B.V.

Updated on 09 May 2018

File name

Abilify_5_10_15_30mg_Tabs_SPC_Dec_2017.docx

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 08 May 2018

File name

Abilify 5, 10, 15, 30mg Tabs PIL Dec 2017.pdf

Reasons for updating

  • New PIL for new product