Genticin Eye/Ear Drops Solution
*Company:
ADVANZ PharmaStatus:
No Recent UpdateLegal 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 28 May 2021
File name
Gentamicin sulf EarEye drops, 3_SPC_IE.pdf
Reasons for updating
- Other
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 May 2021
File name
Gentamicin sulf EarEye drops, 3_PIL_IE.pdf
Reasons for updating
- New PIL for new product
Updated on 06 December 2013
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 December 2013
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:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SEction 10:-Date of Revision of Text
Updated on 06 December 2013
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
Free text change information supplied by the pharmaceutical company
SEction 10:-Date of Revision of Text
Updated on 15 May 2013
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 1: NAME OF MEDICINAL PRODUCT
Removed the word ‘Trade’ from the title of section 1 to read: NAME OF MEDICINAL PRODUCT
Section 2: QUALITATIVE AND QUANTITATIVE COMPOSITION
Inserted the words ‘equivalent to’ to read: Gentamicin Sulphate equivalent to≡ 0.3% w/v gentamicin base.
Inserted a statement regarding the presence of benalkonuim chloride in product.
Section 4.4 Special warnings and special precautions for use
Inserted text regarding the risk of irritation due to the presence of benalkonium chloride.
Section 4.6. Fertility, pregnancy and lactation
Added word ‘fertility’ to title of this section (previously used to read ‘Pregnancy & lactation).
Section 6.6. Special precautions for disposal of a used medicinal product or waste materials, derived from such medicinal product and other handling of the product
Title of section amended to text above.
Section 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Amended to read:
Date of first authorisation: 20 April 1995
Date of last renewal: 20 April 2010
10. DATE OF REVISION OF THE TEXT
Updated to read:
May 2012
Updated on 15 May 2013
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Section 1: NAME OF MEDICINAL PRODUCT
Removed the word ‘Trade’ from the title of section 1 to read: NAME OF MEDICINAL PRODUCT
Section 2: QUALITATIVE AND QUANTITATIVE COMPOSITION
Inserted the words ‘equivalent to’ to read: Gentamicin Sulphate equivalent to≡ 0.3% w/v gentamicin base.
Inserted a statement regarding the presence of benalkonuim chloride in product.
Section 4.4 Special warnings and special precautions for use
Inserted text regarding the risk of irritation due to the presence of benalkonium chloride.
Section 4.6. Fertility, pregnancy and lactation
Added word ‘fertility’ to title of this section (previously used to read ‘Pregnancy & lactation).
Section 6.6. Special precautions for disposal of a used medicinal product or waste materials, derived from such medicinal product and other handling of the product
Title of section amended to text above.
Section 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Amended to read:
Date of first authorisation: 20 April 1995
Date of last renewal: 20 April 2010
10. DATE OF REVISION OF THE TEXT
Updated to read:
May 2012
Updated on 14 August 2008
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 August 2008
Reasons for updating
- New SPC for medicines.ie