Lutinus 100 mg Vaginal Tablets
*Company:
Ferring Ireland LimitedStatus:
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 13 January 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 January 2016
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 3: tablet description updated from 'flat and oval tablet' to 'convex and oblong tablet'
Updated on 13 January 2016
Reasons for updating
- Change to section 3 - Pharmaceutical form
Free text change information supplied by the pharmaceutical company
Section 3: tablet description updated from 'flat and oval tablet' to 'convex and oblong tablet'
Updated on 16 December 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2: Addition of text "Excipient with known effect: 1 vaginal tablet contains approximately 760 mg lactose monohydrate."
Section 4.8: Addition of the HPRA reporting details for adverse events
Section 6.4: Update of storage statement to: "Store in the original container in order to protect from light."
Section 4.8: Addition of the HPRA reporting details for adverse events
Section 6.4: Update of storage statement to: "Store in the original container in order to protect from light."
Updated on 16 December 2014
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
Free text change information supplied by the pharmaceutical company
Section 2: Addition of text "Excipient with known effect: 1 vaginal tablet contains approximately 760 mg lactose monohydrate."
Section 4.8: Addition of the HPRA reporting details for adverse events
Section 6.4: Update of storage statement to: "Store in the original container in order to protect from light."
Section 4.8: Addition of the HPRA reporting details for adverse events
Section 6.4: Update of storage statement to: "Store in the original container in order to protect from light."
Updated on 15 October 2013
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New pack size added to Section 6.5:
The blisters are available in cartons packed with 21 or 90 vaginal tablets with 1 vaginal applicator.
Not all pack sizes may be marketed
Updated on 15 October 2013
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
New pack size added to Section 6.5:
The blisters are available in cartons packed with 21 or 90 vaginal tablets with 1 vaginal applicator.
Not all pack sizes may be marketed
Updated on 06 June 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2: Subsection for 'Paediatric Population' added with the information 'There is no relevant use of Lutinus in the paediatric population.'
Section 4.3: Contraindication added - 'Hypersensitivity to the active substance or to any of hte excipients listed in section 6.1'
Section 4.8: 'Not known' column added to the table along with the following undesirable effects - fatigue, vomiting, hypersensitivity reactions.
Section 4.3: Contraindication added - 'Hypersensitivity to the active substance or to any of hte excipients listed in section 6.1'
Section 4.8: 'Not known' column added to the table along with the following undesirable effects - fatigue, vomiting, hypersensitivity reactions.
Updated on 06 June 2012
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Section 4.2: Subsection for 'Paediatric Population' added with the information 'There is no relevant use of Lutinus in the paediatric population.'
Section 4.3: Contraindication added - 'Hypersensitivity to the active substance or to any of hte excipients listed in section 6.1'
Section 4.8: 'Not known' column added to the table along with the following undesirable effects - fatigue, vomiting, hypersensitivity reactions.
Section 4.3: Contraindication added - 'Hypersensitivity to the active substance or to any of hte excipients listed in section 6.1'
Section 4.8: 'Not known' column added to the table along with the following undesirable effects - fatigue, vomiting, hypersensitivity reactions.
Updated on 20 April 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
None provided
Updated on 20 April 2011
Reasons for updating
- New SPC for new product
Free text change information supplied by the pharmaceutical company
None provided