Celebrex 100 mg Capsules, hard
*Company:
Upjohn EESVStatus:
No Recent UpdateLegal 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 November 2023
File name
Patient Information Leaflet - IE - Celebrex - Klocke 14Nov2023.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 14 November 2023
File name
Patient Information Leaflet - IE - Celebrex - Klocke 14Nov2023.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 11 July 2023
File name
Patient Information Leaflet - Malta LENC - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 17 March 2022
File name
DEC202202890-V_Reg SPC CB 26_0 100mg clean.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 4.6 – updated wording related to oligohydramnios risk with the use of NSAIDs in the 2nd and 3rd trimester; ‘upon discontinuation’ added.
Updated on 04 August 2021
File name
DEC202110079-V_Reg SPC CB 25_0 100mg IE - clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address
Section 8 - updated with new PA number for Upjohn EESV
Updated on 04 August 2021
File name
DEC202110079-V_Reg PIL CB 28_1 IE - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 21 April 2021
File name
DEC202105563-V_Reg SPC CB 24_4 100mg IE - clean.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
- Update to name of the medicinal product in Section 1 and 3 of the SPC
- Addition of Celebrex contains sodium subsection with information related to sodium as excipient in section 4.4 of the SPC
- Addition of influence on driving and use of machines in section 4.7 of the SPC
Minor editorial changes throughout the SPC and QRD alignment
Updated on 21 April 2021
File name
DEC202105563-V_Reg PIL CB 27_3 IE - clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 09 October 2020
File name
Reg PIL CB 26_0 IE clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 16 December 2019
File name
DEC201970444_Reg SPC CB 23_3 100mg IE-clean.pdf
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: In Section 4.4 Special warnings and precautions of use, antiplatelet drugs have been added under the sub section Gastrointestinal(GI) effects. Minor formatting updates have been made to sections 4.2, 4.4 and 4.5. |
Updated on 16 December 2019
File name
DEC201970444_Reg PIL CB 24_0 IE-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 14 November 2019
File name
DEC201963772_Reg SPC CB 22_1 100mg IE.pdf
Reasons for updating
- 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
|
The SPC has been updated as follows: All SPCs - Section 5.1 – Precision study results have been added. |
Updated on 31 July 2018
File name
Reg PIL CB 23_0 IE _1-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 05 June 2018
File name
Reg PIL CB 22_1 IE clean (2).pdf
Reasons for updating
- New PIL for new product
Updated on 18 October 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 October 2017
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: · Section 4.4 updated to clarify that the increase in risk for cardiovascular (CV) thromboembolic events associated with non-aspirin NSAIDs use occurs irrespective of the presence of underlying cardiovascular disease (CVD) or CV risk factors. This update is based on the results of a comprehensive assessment of medical literature and safety database. · Section 4.6 updated with oligohydramnios risk associated with the use of NSAIDs in the second and third trimester of pregnancy. · Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.6 – editorial/QRD changes including spelling of sulphonamide to sulfonamide
|
Updated on 18 October 2017
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Free text change information supplied by the pharmaceutical company
|
The SPC has been updated as follows: · Section 4.4 updated to clarify that the increase in risk for cardiovascular (CV) thromboembolic events associated with non-aspirin NSAIDs use occurs irrespective of the presence of underlying cardiovascular disease (CVD) or CV risk factors. This update is based on the results of a comprehensive assessment of medical literature and safety database. · Section 4.6 updated with oligohydramnios risk associated with the use of NSAIDs in the second and third trimester of pregnancy. · Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 6.6 – editorial/QRD changes including spelling of sulphonamide to sulfonamide
|
Updated on 15 April 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.5 - 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 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 5.3 - updated in order to provide greater granularity of information which could be of relevance for the prescriber, in recognising the safety profile of the medicinal product used for the authorised indications. This change does not impact the PIL.
Sections 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 6.1 – updated in line with QRD v9.1 and minor editorial changes.Updated on 15 April 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.5 - 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 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 5.3 - updated in order to provide greater granularity of information which could be of relevance for the prescriber, in recognising the safety profile of the medicinal product used for the authorised indications. This change does not impact the PIL.
Sections 2, 4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 5.1, 5.2, 6.1 – updated in line with QRD v9.1 and minor editorial changes.Updated on 27 August 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.5 - 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.1, 4.3, 5.1 - editorial changes
Section 4.2 - safety related information pertaining to an alternative method of administration for patients who have difficulty swallowing capsules.
Section 4.4 - safety related information pertaining to the risk of lower gastrointestinal events in patients treated with celecoxib, and interaction of NSAIDs with glucocorticoids, with alcohol and with oral anticoagulants.
Section 4.5 - safety related information pertaining to diminished antihypertensive effect with concomitant use of NSAIDs with antihypertensive drugs (i.e., angiotensin converting enzyme inhibitors [ACEIs], angiotensin II antagonists [ARB], diuretics and beta-blockers) and interaction with ciclosporin. In addition changes are proposed for the current text regarding CYP2D6 inhibition.
Section 4.8 - addition of pneumonitis as ADR plus an update of ADR terms from non MedDRA PT to MedDRA PT terms.
Section 5.2 - information related to absorption of celecoxib and the alternative method of administration for patients who have difficulty swallowing capsules.
Some editorial changes were made to other sections of the SPC.
Updated on 27 August 2015
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.5 - 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
Free text change information supplied by the pharmaceutical company
Sections 4.1, 4.3, 5.1 - editorial changes
Section 4.2 - safety related information pertaining to an alternative method of administration for patients who have difficulty swallowing capsules.
Section 4.4 - safety related information pertaining to the risk of lower gastrointestinal events in patients treated with celecoxib, and interaction of NSAIDs with glucocorticoids, with alcohol and with oral anticoagulants.
Section 4.5 - safety related information pertaining to diminished antihypertensive effect with concomitant use of NSAIDs with antihypertensive drugs (i.e., angiotensin converting enzyme inhibitors [ACEIs], angiotensin II antagonists [ARB], diuretics and beta-blockers) and interaction with ciclosporin. In addition changes are proposed for the current text regarding CYP2D6 inhibition.
Section 4.8 - addition of pneumonitis as ADR plus an update of ADR terms from non MedDRA PT to MedDRA PT terms.
Section 5.2 - information related to absorption of celecoxib and the alternative method of administration for patients who have difficulty swallowing capsules.
Some editorial changes were made to other sections of the SPC.
Updated on 09 September 2014
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
Section 4.8 - ADR ‘accidental injury (injury)’ added as common; frequencies of several other ADRs changed; HPRA details added for reporting of adverse reactions due to IMB name change
Updated on 09 September 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Free text change information supplied by the pharmaceutical company
Section 4.8 - ADR ‘accidental injury (injury)’ added as common; frequencies of several other ADRs changed; HPRA details added for reporting of adverse reactions due to IMB name change
Updated on 26 February 2014
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updates to:
Section 1, Section 2, Section 4.1, Section 4.2, Section 4.3, Section 4.4, Section 4.5, Section 4.6, Section 4.8, Section 5.1, Section 5.2, Section 6.1:
Updated on 26 February 2014
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
Updates to:
Section 1, Section 2, Section 4.1, Section 4.2, Section 4.3, Section 4.4, Section 4.5, Section 4.6, Section 4.8, Section 5.1, Section 5.2, Section 6.1:
Updated on 06 February 2013
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 6.5: clarification of blister type
Updated on 06 February 2013
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Section 6.5: clarification of blister type
Updated on 17 January 2013
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
Sections 4.4 & 4.5: information on interaction of NSAIDs with ACE inhibitors added; Section 4.8: Drug rash with eosinophilia and systemic symptoms (DRESS) or hypersensitivity syndrome added as ADR.
Updated on 17 January 2013
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
Free text change information supplied by the pharmaceutical company
Sections 4.4 & 4.5: information on interaction of NSAIDs with ACE inhibitors added; Section 4.8: Drug rash with eosinophilia and systemic symptoms (DRESS) or hypersensitivity syndrome added as ADR.
Updated on 29 February 2012
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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
SPC - Sections 7 (MAH name), 8 (MA number), 10 (revision date)
Updated on 29 February 2012
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
SPC - Sections 7 (MAH name), 8 (MA number), 10 (revision date)
Updated on 24 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 October 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 18 November 2010
Reasons for updating
- 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
Updated on 18 November 2010
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Updated on 23 August 2010
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- 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
SmPC
4.8 - addition of adverse reactions
6.1 - addition of shellac and propylene glycol as excipients in the Ink (note the excipients have not changed, just the description in the SmPC & PIL)
6.5 - addition of statement indicating that not all pack sizes are marketed
9 - update to date last renewed
10 - date of revision of text updated
Updated on 23 August 2010
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
SmPC
4.8 - addition of adverse reactions
6.1 - addition of shellac and propylene glycol as excipients in the Ink (note the excipients have not changed, just the description in the SmPC & PIL)
6.5 - addition of statement indicating that not all pack sizes are marketed
9 - update to date last renewed
10 - date of revision of text updated
Updated on 03 August 2009
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- 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
Section 6.5 - addition of a bulk pack size
Section 10 - date last updated
Updated on 03 August 2009
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 6.5 - addition of a bulk pack size
Section 10 - date last updated
Updated on 22 January 2009
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
4.4: addition of information about reported cases of severe hepatic reactions
4.8 addition of post-marketing adverse drug reactions: fulminant hepatitis, liver necrosis, acute generalised exanthematous pustulosis and expansion of hepatic failure text to include sometimes fatal or requiring liver transplant
Updated on 22 January 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
4.4: addition of information about reported cases of severe hepatic reactions
4.8 addition of post-marketing adverse drug reactions: fulminant hepatitis, liver necrosis, acute generalised exanthematous pustulosis and expansion of hepatic failure text to include sometimes fatal or requiring liver transplant
Updated on 12 May 2008
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- 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
2 – addition of quantity of lactose monohydrate
4.2 – addition of advice for CYP2C9 poor metabolisers
4.4 – advice to monitor blood pressure as celecoxib can lead to onset of new or worsening of existing hypertension, advice to monitor patients at greatest risk of renal toxicity
4.5 – addition of results from interaction study with lisinopril, ciclosporin spelling updated, advice for CYP2C9 poor metabolisers
4.6 – administration of celecoxib to a limited number of lactating women has shown a very low rate of transfer of celecoxib into breast milk
4.8 – extensively rewritten to include adverse events from PSUR11, PreSAP and APC trials
5.1 – addition of Pharmacotherapeutic group, addition of data from PreSAP, APC and ADAPT trials
5.2 – addition of CYP2C9 data
6.1 – administrative update
9 – addition of date of last renewal
10 – update to date last updated
Updated on 12 May 2008
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
2 – addition of quantity of lactose monohydrate
4.2 – addition of advice for CYP2C9 poor metabolisers
4.4 – advice to monitor blood pressure as celecoxib can lead to onset of new or worsening of existing hypertension, advice to monitor patients at greatest risk of renal toxicity
4.5 – addition of results from interaction study with lisinopril, ciclosporin spelling updated, advice for CYP2C9 poor metabolisers
4.6 – administration of celecoxib to a limited number of lactating women has shown a very low rate of transfer of celecoxib into breast milk
4.8 – extensively rewritten to include adverse events from PSUR11, PreSAP and APC trials
5.1 – addition of Pharmacotherapeutic group, addition of data from PreSAP, APC and ADAPT trials
5.2 – addition of CYP2C9 data
6.1 – administrative update
9 – addition of date of last renewal
10 – update to date last updated
Updated on 05 April 2007
Reasons for updating
- 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
Updated on 05 April 2007
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Updated on 09 March 2007
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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
Section 4.2 dosing instructions for AS indication
Updated on 09 March 2007
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.2 dosing instructions for AS indication
Updated on 19 April 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 19 April 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Updated on 11 May 2005
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- 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)
Updated on 11 May 2005
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Updated on 12 July 2004
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 July 2004
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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Updated on 18 March 2004
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 18 March 2004
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Updated on 03 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 July 2003
Reasons for updating
- New SPC for medicines.ie