Summary of Product Characteristics
last updated on the eMC:
16/04/2012
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 16/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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: 11-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The key changes are:
Update to manufacturer names and removal of trading style
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Updated on 18/06/2009 and displayed until 16/04/2012
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 23-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Update to Sections 5.3, 9 & 10 following approval of the Renewal.
The key change is to Section 5.3:
Prevous text:
There are no preclinical safety data which could be of relevance to the prescriber and which are not already included in other relevant sections of the SPC.
New MHRA approved text:
Besides the studies with the active ingredient norethisterone enantate, data recorded for norethisterone and norethisterone acetate were also taken into consideration for the toxicological evaluation of the risk from use of Noristerat.
In animal studies on systemic tolerance with repeated administration (including studies for evaluation of a tumorigenic activity), no systemic intolerance reactions were observed which would raise objections to the use of the preparation in dosages required for contraception.
On principle, however, it should be kept in mind that sex steroids might stimulate the growth of hormone-dependent tissues and tumours.
In reproduction toxicological studies no indication of a teratogenic potential was noted. This is in accordance with reports on clinical experience after accidental administration of Noristerat during pregnancy or on the rare cases of pregnancies occurring during use of Noristerat, where no indication of a teratogenic potential was noted.
Local tolerance was assessed in the course of systemic tolerance studies and indicated only a mild irritant potential of the drug substance. The good local tolerance has been confirmed by long-term clinical experience.
Experimental investigations into possible sensitising effects of norethisterone enantate have not been carried out.
In vitro studies for evaluation of genotoxicity did not indicate that norethisterone or its esters possess a mutagenic potential.
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Updated on 10/03/2009 and displayed until 18/06/2009
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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 6.2 - Incompatibilities
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| Date of revision of text on the SPC: 07-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The key changes to the SmPC are:
- Section 1 'Name of the Medicinal Product' has been amended in line with the requirements of the SmPC guideline to include the strength and pharmaceutical form of the product;
- Section 2 'Qualitative and Quantitative Composition' has been reworded for greater clarity;
- Section 6.2 'Incompatibilities' has been reworded to reflect current terminology in line with EU Guidelines on SMPCs.
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Updated on 28/05/2008 and displayed until 10/03/2009
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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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: 01-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| All updates are due to change of ownership, from Schering Healthcare Ltd to Bayer Plc effective from 1 May 2008.
Section 7: MAH now Bayer plc
Section 8: Licence number is now PL 00010/ 0548
Section 9: Date of first authorisation is now 1 May 2008
Section 10: Revision date is now 1 May 2008
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Updated on 31/08/2004 and displayed until 28/05/2008
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Reasons for adding or updating:
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Change to section 2 - qualitative and quantitative composition
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 10 (date of (partial) revision of the text
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Updated on 17/03/2004 and displayed until 31/08/2004
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 06/09/1999 and displayed until 17/03/2004
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Reasons for adding or updating:
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