Lutinus 100 mg Vaginal Tablets

  • Name:

    Lutinus 100 mg Vaginal Tablets

  • Company:
    info
  • Active Ingredients:

    Progesterone

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Summary of Product Characteristics last updated on medicines.ie: 13/1/2016
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Ferring Ireland Limited

Ferring Ireland Limited

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Medicine Name Gonapeptyl Depot 3.75 mg powder and solvent for suspension for injection Active Ingredients triptorelin acetate
Medicine Name Lutinus 100 mg Vaginal Tablets Active Ingredients Progesterone
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1 - 0 of 35 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13 January 2016 PIL

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 13 January 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 13 January 2016 SmPC

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 16 December 2014 PIL

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."

Updated on 16 December 2014 SmPC

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."

Updated on 15 October 2013 PIL

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 15 October 2013 SmPC

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 6 June 2012 PIL

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.

Updated on 6 June 2012 SmPC

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.

Updated on 20 April 2011 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided

Updated on 20 April 2011 SmPC

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