Summary of Product Characteristics
last updated on the eMC:
01/03/2012
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 01/03/2012 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: 01-Sep-2011 |
| 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:
· Removal of the Trading Style from Section 7 of the SmPCs for Ciproxin Tablets, Infusion and Suspension, with a consequential removal of the 'Bayer Schering Pharma Logo' from the packaging.
· To update the name of the finished product manufacturer (Batch Release site) from 'Bayer Schering Pharma AG' to ''Bayer Pharma AG' with a consequential change to the PILs.
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Updated on 27/04/2010 and displayed until 01/03/2012
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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 3 - Pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 6 - Instructions for use, handling and disposal
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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-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections 2, 3 & 6 have been extensively updated to reflect changes to the registered Quality information.
Section 10 - Revision date is now April 2010
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Updated on 24/11/2008 and displayed until 27/04/2010
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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 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 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6. 6 - Instructions for use, handling and disposal
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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: 17-Nov-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Some of the key changes are as follows:
- Section 4.1 (Therapeutic indications): significant changes based on information available on resistance for each adult indication.
- Section 4.2 (Posology and method of administration): updated in-line with section 4.1 and addition of guidance on dose adjustments in renally impaired elderly patients.
- Section 4.4 (Special warnings and precations for use): additional warnings and precautions (several on suitability of treatment with Ciproxin plus those on cardiac disorders, hepatobiliary system, resistance, cytochrome P450 and methotrexate).
- Section 4.5 (Interaction with other medicinal products and other forms of interaction): additional interactions (xanthine derivatives, clozapine).
- Section 4.8 (Undesirable effects): conversion to MedDRA terminology.
- Sections 5.1-5.3 (Pharmacological Properties): addition of new pharmacodynamic (including updated resistance data)/pharmacokinetic and preclinical data.
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Updated on 22/09/2008 and displayed until 24/11/2008
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Company name change or merger
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| Date of revision of text on the SPC: 11-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 10 : Revision date is now 11.09.2008.
Update is due to change in trading style of the company from Bayer plc to Bayer Schring Pharma
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Updated on 27/05/2008 and displayed until 22/09/2008
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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 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 17-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Amendments to the SmPC, Sections 4.1, 4.2, 4.3, 4.4, 4.8, 5.2 and 5.3 following the EU work sharing project assessment of paediatric data.
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Updated on 31/10/2007 and displayed until 27/05/2008
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Reasons for adding or updating:
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New individual SPC (was previously included in combined SPC)
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| Date of revision of text on the SPC: 01/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The combined SmPC for Ciproxin Tablets has been replaced with SmPCs for the individual strengths.
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