Arcoxia 30 60 90 120 film-coated tablets
*Company:
Organon Pharma (Ireland) LimitedStatus:
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 26 January 2023
File name
ARCOXIA combined SPC-PT-H-2299-MAT Oct21-IE-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 January 2023
File name
ARCOXIA combined SPC-PT-H-2299-MAT Oct21-IE-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 October 2021
File name
ARCOXIA combined SPC-PT-H-2299-MAT Oct21-IE-CRT.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 October 2021
File name
Arcoxia Combined QRD_PIL_WS33 + MAT_CRT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 20 May 2021
File name
ARCOXIA combined SPC-PT-H-2299-WS-033-IE-en-CRT.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
To comply with the revised Annex to the European Commission guideline on "Excipients in the labelling and package leaflet of medicinal products for human use".
Updated on 20 May 2021
File name
ARCOXIA combined PIL-PT-H-2299-WS-033-IE-en-CRT.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 25 June 2019
File name
ARCOXIA-WS156_IA447G-SPC-IE-en-clean July 2016.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Converted the SPC from word format to pdf file format
Updated on 09 August 2018
File name
QRD_PIL_Arcoxia deletion of UK details_CRT (2).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 16 April 2018
File name
ie-pl-arcoxia-notification (2).pdf
Reasons for updating
- Change to section 6 - date of revision
- Change of distributor details
Updated on 15 August 2016
File name
PIL_16094_107.pdf
Reasons for updating
- New PIL for new product
Updated on 15 August 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 August 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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 4.2 – Posology: revised the recommended dosage for Rheumatoid Arthritis (RA) and Ankylosing spondylitis (AS) from 90mg to 60mg once daily
• Section 4.8 – Undesirable effects: updated number of patients in summary of safety profile.
• Section 5.1 – Pharmacodynamic properties: updated clinical efficacy details concerning RA and AS
• Section 6.5 – Nature and contents of container: Added the 98 tablets mono-pack size for Arcoxia 30mg and 60mg and corrected the spelling of ‘aluminium’
Updated on 15 August 2016
Reasons for updating
- Change to dosage and administration
- Introduction of new pack/pack size
Updated on 14 December 2015
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
· Section 7 – Marketing authorisation holder: The address of the Marketing authorisation holder has been changed to ‘Merck Sharp & Dohme B.V., Waarderweg 39, Haarlem, 2031 BN, The Netherlands’
· Section 8 – Marketing authorisation number: The MA numbers have been updated to PA 1997/1/1 - 4
· Section 10 – Date of revision: November 2015
Updated on 14 December 2015
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 29 April 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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
- Section 2 – Qualitative and quantitative composition: Wording updated in the reference to excipients in line with the QRD template.
- Section 3 – Pharmaceutical form: Section updated in line with the latest QRD template
- Section 4.1 – Therapeutic indication: This section of the SmPC was updated to define the target population indicated for the use of this drug.
- Section 4.2 – Posology and method of administration: Subheading and headings updated in line with the QRD template; also wording added to the paragraph under the subheading ‘Postoperative dental surgery pain’ regarding the treatment period for Arcoxia.
- Section 4.3 – Contra-indications: The third bullet point has been updated as follows:
· Patients who, after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors, have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticarial, or allergic-type reactions. after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors
- Section 4.8 – Undesirable effects: The heading ‘Adverse Experience Term’ in table 1 has been replaced with ‘Adverse Reactions’, in accordance with the QRD template. Addition of AE reporting statement for IE.
- Section 5.1 – Pharmacodynamic properties: Section updated in line with the latest QRD template
- Section 5.2 – Pharmacokinetic properties: Subheadings revised as per the QRD template.
- Section 6.6 – Special precautions for disposal: Addition of statement on disposal of unused medicinal product in line with the QRD template.
Updated on 29 April 2015
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 17 March 2015
Reasons for updating
- Change to date of revision
Updated on 10 October 2014
Reasons for updating
- Change of distributor details
Updated on 11 September 2014
Reasons for updating
- Correction of spelling/typing errors
Updated on 08 September 2014
Reasons for updating
- New PIL for medicines.ie
Updated on 05 September 2014
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)