Celluvisc 0.5%
*Company:
AbbVie LimitedStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 April 2022
File name
Celluvisc 0.5 SPC IE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 12 April 2022
File name
Celluvisc 0.5 PIL.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 04 March 2020
File name
Celluvisc 0.5 PIL IE V4.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 16 February 2015
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 16 February 2015
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 12 February 2015
File name
PIL_11674_282.pdf
Reasons for updating
- New PIL for new product
Updated on 12 February 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 04 June 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 30 May 2014
Reasons for updating
- Changes to therapeutic indications
- Change to storage instructions
- Change to side-effects
- Change to information about driving or using machinery
- Change to date of revision
Updated on 10 March 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Summary of Changes to Celluvisc® 0.5% Irish Summary of Product Characteristics (SPC)
The current Celluvisc® SPC is dated 17th December 2010
This supersedes SPC dated 10th November 2006
|
Section Number |
Subject |
Change |
|
4.8 |
Undesirable effects |
Added Text: The frequency of adverse reactions documented during clinical trials is given. The frequency is defined as follows: Very Common (³ 1/10); Common (³1/100, <1/10); Uncommon (³1/1,000, <1/100); Rare (³1/10,000, <1/1,000); Very Rare (<1/10,000), not known (cannot be estimated from the available data).
Eye disorders:
Common: Eye Irritation
The following other adverse reactions have reported since Cellufluid has been marketed: Eye pain, vision blurred, lacrimation increased, ocular hyperaemia.
Deleted Text:
|
|
10 |
Date of Revision of Text |
Text added:
|
Key:
Unchanged text appears as follows: eg sodium hydroxide
Added text appears as follows: eg Celluvisc
Deleted text appears as follows: eg Not applicable
Updated on 09 March 2011
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 21 February 2011
Reasons for updating
- Change to improve clarity and readability
Updated on 24 November 2006
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 24 November 2006
Reasons for updating
- New PIL for new product