Zemplar capsules, soft
- Name:
Zemplar capsules, soft
- Company:
AbbVie Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/12/19
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AbbVie Limited
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 17 December 2019 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 17 December 2019 PIL
Reasons for updating
- Change to date of revision
Updated on 2 December 2019 SmPC
Reasons for updating
- Change from individual to joint SmPC
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 2 December 2019 PIL
Reasons for updating
- Individual PILs superseded by joint PIL
Updated on 29 April 2019 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 27 March 2019 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 18 July 2018 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 23 March 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 23 March 2018 SmPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 22 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 22 March 2018 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 21 March 2018 SmPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 March 2018 SmPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 19 March 2018 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 7 December 2017 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 11 March 2016 SmPC
Reasons for updating
- Change to MA holder contact details
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Ø Update the IE MAH address:
|
Present: |
Proposed: |
|
AbbVie Limited Block B Liffey Valley Office Campus Quarryvale Co. Dublin
|
AbbVie Limited Citywest Business Campus Dublin 24 Ireland |
Updated on 10 March 2016 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 17 November 2015 PIL
Reasons for updating
- Change to side-effects
Updated on 17 November 2015 SmPC
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
Updated on 23 September 2015 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 18 June 2015 PIL
Reasons for updating
- Addition of manufacturer
Updated on 27 November 2014 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
To update Section 4.2 of the SPC to include dosing on renal transplant patients.
Updated on 26 November 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 11 September 2014 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 29 July 2014 SmPC
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
Updated on 23 July 2014 PIL
Reasons for updating
- Change to side-effects
- Addition of information on reporting a side effect.
Updated on 17 July 2013 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Section 4.4:
The following text was added:
Phosphate or vitamin D-related medicinal products should not be taken concomitantly with
paricalcitol due to an increased risk of hypercalcaemia and Ca x P product elevation (see Section
4.5).
In pre-dialysis patients, paricalcitol, like other vitamin D receptor activators, may increase
serum creatinine (and therefore decrease the estimated GFR [eGFR]) without changing true
glomerular filtration rate (GFR).
- Section 6.1:
The composition of the Black ink was updated to replace Polyethylene glycol 400 with Macrogal 400.
- Section 6.5:
This section was updated with e following text
High-density polyethylene (HDPE) bottles closed with children resistant polypropylene caps. Each bottle contains 30 capsules.
PVC/fluoropolymer/aluminium blister strips containing 7 capsules. Each carton contains 1 or 4 blisters strips. Packaged in outer cartons containing either 7 or 28 capsules.
- Section 7:
This section was update to AbbVie name and Address:
AbbVie Limited
Block B
Liffey Valley Office Campus
Quarryvale
Co. Dublin
- Section 8:
PA number updated to AbbVie new PA, PA 1824/5/1
Updated on 12 July 2013 PIL
Reasons for updating
- Change of licence holder
- Change to further information section
Updated on 8 August 2011 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC section 5.1 - to inlcude 'Unlike calcitriol, paracalcitol is a selective Vitamin D receptor (VDR) activator' in line with WHO reclassification of paricalcitol from 'Vitamin D analogs' (ATC Code: A11CC) to 'Anti-parathyroid agents' (ATC Code: HO5BX).
Updated on 25 February 2011 SmPC
Reasons for updating
- 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 has been updated to add a warning regarding chronic hypercalcaemia and it's possible association with generalised vascular calcification and other soft tissue calcification.
Section 4.5 has been updated to add information on interactions with drugs that impair intestinal absorption of fat-soluble
vitamins, such as cholestyramine.
Updated on 23 February 2011 PIL
Reasons for updating
- Change to drug interactions
Updated on 29 July 2010 SmPC
Reasons for updating
- Change to joint SPC covering all presentations
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 28 July 2010 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 13 January 2010 SmPC
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 21 July 2008 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 13 February 2008 PIL
Reasons for updating
- New PIL for new product
Updated on 11 February 2008 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)