Detrusitol 1 mg filmcoated tablets
*Company:
Upjohn EESVStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 19 July 2023
File name
Patient Information Leaflet - 003052975 - version 1.0 - Detrusitol 1mg and 2mg FCT - clean - removal of MT details.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 21 April 2021
File name
DEC202105560-V_Reg SPC DT 11_1 1mg Tabs IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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The SPC has been updated as follows: Section 7 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address Section 8 - updated with new PA number for Upjohn EESV
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Updated on 21 April 2021
File name
DEC202105560-V_REG PIL DT 13_0 1mg and 2mg IE-clean.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 02 March 2021
File name
DEC202102853-V_Reg SPC DT 9_1 1mg Tabs IE-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
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The SPC has been updated as follows: Capsules - Section 2: Excipient heading added Tablets |
Updated on 02 March 2021
File name
DEC202102853-V_REG PIL DT 11_1 1mg and 2mg IE-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 October 2018
File name
REG PIL DT 10_1 1mg 2mg IE-Clean_.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 19 October 2018
File name
Reg SPC DT 8_1 1mg Tabs IE-Clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 July 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 30 July 2015
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows.
Section 4.8 Reporting of suspected adverse reactions – QRD text added.
Updated on 28 July 2015
File name
PIL_8885_124.pdf
Reasons for updating
- New PIL for new product
Updated on 28 July 2015
Reasons for updating
- Change to side-effects
Updated on 09 April 2013
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
or PP Child Resistant Squeeze and Turn closures.
Updated on 14 May 2012
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 09 May 2012
Reasons for updating
- Change of licence holder
- Change to date of revision
- Change in co-marketing arrangement
Updated on 20 February 2012
Reasons for updating
- PIL re-instated
Updated on 20 January 2012
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 29 July 2010
Reasons for updating
- Change of manufacturer
Updated on 10 December 2008
Reasons for updating
- Change to side-effects
Updated on 09 December 2008
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 has been updated to include the most common side effects with the tabulated listing.
Updated on 15 July 2008
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 15 July 2008
Reasons for updating
- Change to drug interactions
- Change to side-effects
Updated on 07 March 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 December 2007
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
7.0 – Marketing Authorisation Holder (Address)
Updated on 06 December 2007
Reasons for updating
- Change to marketing authorisation holder address
Updated on 14 June 2007
Reasons for updating
- Change to side-effects
Updated on 18 May 2007
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.8 – Revision of section to more closely align with the core data sheet
Updated on 20 April 2007
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 17 April 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 addition of wording to increase clarity
Section 4.2 amended wording regarding paediatric use
Section 4.5 minor grammatical change to text
Section 4.8 inclusion of text on experience with paediatric use
Section 4.9 minor grammatical change to text
Section 5.1 inclusion of text on experience with paediatric use
Section 5.2 inclusion of text on experience with paediatric use
Section 6.6 Update in line with current EU guidelines
Updated on 28 November 2005
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 11 November 2005
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 November 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 06 August 2004
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 July 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Upjohn EESV
Address:
Rivium Westlaan 142, 2909 LD Capelle aan de Ijssel, NetherlandsMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44(0) 1707 853000 press 1