Menopur 1200IU powder and solvent for solution for injection

  • Name:

    Menopur 1200IU powder and solvent for solution for injection

  • Company:
    info
  • Active Ingredients:

    Menotrophin

  • Legal Category:

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

Summary of Product Characteristics last updated on medicines.ie: 27/1/2016
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Ferring Ireland Limited

Ferring Ireland Limited

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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 27 January 2016 PIL

Reasons for updating

  • 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 9: new text: 'Date of renewal: 17th June 2016'
Section 10: revision of text updated to 'January 2016'

Updated on 27 January 2016 SmPC

Reasons for updating

  • 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 9: new text: 'Date of renewal: 17th June 2016'
Section 10: revision of text updated to 'January 2016'

Updated on 27 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 25 June 2015 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4.8 - reporting of side effects section added

Updated on 25 June 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Free text change information supplied by the pharmaceutical company

Section 4.8 - reporting of side effects section added

Updated on 24 July 2013 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage

Free text change information supplied by the pharmaceutical company

Section 2:
sentence added:  “
Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in postmenopausal urine, is present in MENOPUR and is the main contributor of the LH activity.”


 Section 4.2:
-
"Method of administration" moved to end of section
- "Paediatric population" secton added
- sentence udpated from "In line with clinical trials with Menopur that involved downregulation with GnRH agonists Menopur therapy should start approximately 2 weeks after the start of agonist treatment"
to 
 "In a protocol using down-regulation with a GnRH agonist MENOPUR therapy should start approximately 2 weeks after the start of agonist treatment.  In a protocol using down-regulation with a GnRH antagonist, MENOPUR therapy should start on day 2 or 3 of the menstrual cycle."


Section 4.6:
Section updated to:

"Fertility

MENOPUR is indicated for use in infertility (see section 4.1).

 

Pregnancy

MENOPUR is contraindicated in women who are pregnant (see section 4.3).

There are no or limited amount of data from the use of menotrophins in pregnant women.  No animal studies have been carried out to evaluate the effects of MENOPUR during pregnancy (see section 5.3).

 

Lactation

MENOPUR is contraindicated in women who are lactating (see section 4.3)"



Section 4.8:
Full section update

Sections 5.3:

Full update

Section 6.4:
Sentence added: “
For storage conditions after reconstitution of the medicinal product, see section 6.3.”

Updated on 24 July 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • 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:
sentence added:  “
Human Chorionic Gonadotrophin (hCG), a naturally occurring hormone in postmenopausal urine, is present in MENOPUR and is the main contributor of the LH activity.”


 Section 4.2:
-
"Method of administration" moved to end of section
- "Paediatric population" secton added
- sentence udpated from "In line with clinical trials with Menopur that involved downregulation with GnRH agonists Menopur therapy should start approximately 2 weeks after the start of agonist treatment"
to 
 "In a protocol using down-regulation with a GnRH agonist MENOPUR therapy should start approximately 2 weeks after the start of agonist treatment.  In a protocol using down-regulation with a GnRH antagonist, MENOPUR therapy should start on day 2 or 3 of the menstrual cycle."


Section 4.6:
Section updated to:

"Fertility

MENOPUR is indicated for use in infertility (see section 4.1).

 

Pregnancy

MENOPUR is contraindicated in women who are pregnant (see section 4.3).

There are no or limited amount of data from the use of menotrophins in pregnant women.  No animal studies have been carried out to evaluate the effects of MENOPUR during pregnancy (see section 5.3).

 

Lactation

MENOPUR is contraindicated in women who are lactating (see section 4.3)"



Section 4.8:
Full section update

Sections 5.3:

Full update

Section 6.4:
Sentence added: “
For storage conditions after reconstitution of the medicinal product, see section 6.3.”

Updated on 1 November 2011 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided

Updated on 1 November 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