ABILIFY 7.5 mg/ml solution for injection

*
Pharmacy Only: Prescription
  • 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

Updated on 14 April 2022

File name

Abilify 7.5 mg_mL solution for injection PIL IE.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

This type IB variation is to add “blood prolactin decreased” as an ADR to section 4. Possible side effects of the Package Leaflet.

The product information was also updated according QRD standard statement and excipients guideline.

Updated on 14 April 2022

File name

Abilify 7.5 mg_mL solution for injection SmPC IE.pdf

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

This type IB variation was to add “blood prolactin decreased” as an ADR to section 4.8 of the SmPC.

The product information was also updated according QRD standard statement and excipients guideline.

Updated on 24 December 2021

File name

ema-pil-solution for inj-IE.pdf

Reasons for updating

  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Package Leaflet Section 6. Contents of the pack and other information (all formulations): 

Change of Local Representative from Otsuka Pharmaceuticals (UK) Ltd. to Otsuka Pharmaceutical Netherlands B.V.

Updated on 20 October 2020

File name

ABILIFY 7,5 mg-ml IM PIL-Ireland.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 7,5 mg-ml IM SPC-Ireland.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 7,5 mg-ml IM PIL-Ireland.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 7,5 mg-ml IM SPC- Ireland.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 22 October 2019

File name

Abilify 7.5 mg IM Sodium update - PIL IE.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Minor editorial changes to the PIL made.

In section 2, additional statement on the product containing sodium.

Updated on 21 October 2019

File name

Abilify soln for inj Sodium update - SPC Ireland.pdf

Reasons for updating

  • 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

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 statement on sodium content

Section 4.6: added word 'metabolites' to section on breastfeeding

Section 4.8: reclassification of a number of adverse events under 'Investigations'. Editorial changes made as well

Updated on 13 May 2019

File name

Abilify 7.5mg-ml IM PIL Ireland.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 09 May 2019

File name

Abilify 7.5mg-ml IM SmPC Ireland.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

The SmPC has been updated as follows:

Update to Section 4.4 Special warnings and precautions for use

Falls

Aripiprazole may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls. Caution should be taken when treating patients at higher risk, and a lower starting dose should be considered (e.g., elderly or debilitated patients; see section 4.2). 

 

Update to Section 4.8 Undesirable effects:

Oculogyric crisis is listed under Not known

Updated on 11 December 2018

File name

Abilify MAH change 7.5 mgml injection - PIL IE.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 11 December 2018

File name

Abilify 7.5 mgml Solution MAH Change - SPC IE.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 13 May 2018

File name

Abilify 7.5mgml Solution for Injection PIL Dec 2017.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 May 2018

File name

Abilify_7.5mgml_Solution_for_Injection_SPC_Dec_2017.docx

Reasons for updating

  • New SPC for new product

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