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Depo-Provera 150mg/ml

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Medroxyprogesterone Acetate

    *Additional information is available within the SPC or upon request to the company

Updated on 13 February 2023

File name

DEC202126469_Reg SPC DP 13_1 IE (clean).pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 April 2021

File name

DEC202126469_Reg SPC DP 13_1 IE (clean).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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 May 2020

File name

DEC202031696_Reg SPC DP 12_2 IE-clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 May 2020

File name

DEC202031696_Reg HCP DP 9_2 & PIL DP 10_2 IE-clean.pdf

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 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 14 February 2020

File name

Depo-Provera® 150 mg_ml Suspension for Injection_HCP - Clean .pdf

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
  • Change to information for healthcare professionals

Updated on 20 November 2019

File name

DEC201964956_Reg SPC DP 11_3 IE-clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.1 : minor changes only (no change to clinical meaning)

Section 4.2: cross-referencing updated

Section 4.4: information included on bone mineral density and PRAC required wording on suicidality

Section 5.1: information included on bone mineral density

Updated on 20 November 2019

File name

DEC201964956_Reg HCP DP 9_2 & PIL DP 9_2 IE-clean.pdf

Reasons for updating

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

Updated on 31 August 2018

File name

Reg HCP DP 8_2 & PIL DP 8_3 IE Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 31 August 2018

File name

Reg SPC DP 10_2 IE Clean.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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Update to Section 4.4 of the  medroxyprogesterone acetate SmPCs to include new information recently added to the Company Core Data Sheet concerning use of progestogen containing injectable contraceptives like medroxyprogesterone acetate suspension for injection, and sexually transmitted infections.

Additionally ADR reporting statement in section 4.8  of SmPC has been updated.

Updated on 07 June 2018

File name

Reg HCP DP 6_1 & PIL DP 7_1 IE_Clean.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 19 May 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 19 May 2016

Reasons for updating

  • 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

Update to section 4.8 - frequencies of ADRs added together with QRD changes.

Updated on 17 May 2016

File name

PIL_9571_331.pdf

Reasons for updating

  • New PIL for new product

Updated on 17 May 2016

Reasons for updating

  • Change of contraindications
  • Change to side-effects
  • Change to date of revision

Updated on 08 March 2016

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated in section 5.1 to add mechanism of action

Updated on 07 March 2016

Reasons for updating

  • Change to further information section

Updated on 01 May 2015

Reasons for updating

  • 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

The SPC has been updated in section 4.8 to correct spelling of ADRs together with editorial changes

Updated on 16 December 2014

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Administrative changes in line with QRD 09

And addition of text below to Section 4.5

Medroxyprogesterone acetate (DMPA) is metabolized in-vitro primarily by hydroxylation via the CYP3A4. Specific drug-drug interaction studies evaluating the clinical effects with CYP3A4 inducers or inhibitors on MPA have not been conducted and therefore the clinical effects of CYP3A4 inducers or inhibitors are unknown.

Updated on 10 December 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability

Updated on 11 October 2012

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Sections 7-Marketing authorisation holder: updated to include Pfizer Healthcare Ireland name

Section 8-Marketing authorisation number: updated to include new Product license number

Updated on 02 October 2012

Reasons for updating

  • Change to marketing authorisation holder

Updated on 20 January 2012

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 14 November 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 21 October 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

SmPC updates to section 7 -  MA Holder’s name change and Section 10 – revision date.

Updated on 20 October 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 22 February 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 09 August 2010

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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.2, 4.3, 4.4, 4.8, 5.1 and 5.2 are update in line with, the Company  Core Data sheet for Depo-Provera. It also includes an update in section 4.4 and 5.1 with new data on bone mineral density.

Updated on 05 August 2010

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 14 August 2008

Reasons for updating

  • Change to date of revision

Updated on 24 October 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 Changes to the following sections of the SPC have been made during this renewal assessment: Section 1 Name of the Medicinal Product: Addition of ‘Suspension for Injection’, Section 2: Qualitative and Quantitative Composition: change in wording to include ‘each pre-filled syringe’, Section 6.3 Shelf Life: change from ’36 months’ to ‘3 years’.

Updated on 21 October 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 October 2005

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to date of revision

Updated on 27 April 2005

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 April 2005

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)