Summary of Product Characteristics
last updated on the eMC:
17/06/2009
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 17/06/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 08-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 1
Premique Low Dose 0.3 mg/1.5 mg coated tablets.
Premique Low Dose 0.3mg/1.5mg modified release tablets
Section 2
Premique Low Dose 0.3 mg/1.5 mg coated tablets modified release tablets are for oral administration containing conjugated estrogens† 0.3 mg and medroxyprogesterone acetate (MPA) 1.5 mg.
Section 3
Coated tablet.
Modified release tablet.
Section 10
22 July 2008 08 June 2009
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Updated on 12/08/2008 and displayed until 17/06/2009
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Reasons for adding or updating:
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Change to section 4.9 - Overdose
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 22-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2
New wording added under subheading 'Maintenance/Continuation/Extended Treatment'
Section 4.8
Table revised and additional side effects added
Section 4.9
Wording updated in line with global company prescribing information
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Updated on 11/06/2008 and displayed until 12/08/2008
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 4 - Special Precautions for Storage
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| Date of revision of text on the SPC: 23-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.4
The following sentence has been added 'Keep blister in the outer carton to protect from light.'
Section 6.5
The following text replaces current packaging information: 'Each carton contains 28 tablets (1 blister pack) or 84 tablets (3 blister packs).Not all pack sizes may be marketed.'
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Updated on 07/05/2008 and displayed until 11/06/2008
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 15-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 (Posology and method of administration) the following text has been added: Patients should be re-evaluated periodically to determine if treatment for symptoms is still necessary.
Section 10 (DATE OF REVISION OF THE TEXT) the date has been amended to:
15th April 2008
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Updated on 20/09/2006 and displayed until 07/05/2008
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 15/09/2006 and displayed until 20/09/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 10/02/2006 and displayed until 15/09/2006
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 (date of (partial) revision of the text
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Change to section 4.8 - Undesirable Effects
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Updated on 10/05/2004 and displayed until 10/02/2006
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Reasons for adding or updating:
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