Menopur 1200IU powder and solvent for solution for injection
- Name:
Menopur 1200IU powder and solvent for solution for injection
- Company:
Ferring Ireland Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Ferring Ireland Limited
Company Products
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 10: revision of text updated to 'January 2016'
Updated on 27 January 2016 SPC
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 10: revision of text updated to 'January 2016'
Updated on 27 January 2016 SPC
Reasons for updating
- New SPC 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
Updated on 25 June 2015 SPC
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
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 SPC
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
Updated on 1 November 2011 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)