Depo-Provera 150mg/ml
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
UpdatedLegal 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 16 October 2024
File name
Reg HCP DP 10_0 & PIL DP 11_0 IE (clean).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
The PIL has been updated to reflect the SPC change for the MAH name and address.
Updated on 16 October 2024
File name
Reg SPC DP 14_0 IE (clean).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
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 7 Change of MAH name and address
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
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
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
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
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
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)