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Zimovane 7.5mg Film-coated Tablets

*
Pharmacy Only: Prescription

  • Company:

    Mylan IRE Healthcare Ltd

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Zopiclone

    *Additional information is available within the SPC or upon request to the company

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Updated on 27 November 2023

File name

ie-pl-zimovane-pr3299763-maht-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 27 November 2023

File name

ie-pl-zimovane-pr3299763-maht-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 27 November 2023

File name

ie-spc-zimovane-pr3299763-maht-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 November 2023

File name

ie-spc-zimovane-pr3299763-maht-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 November 2023

File name

ie-spc-zimovane-pr3299763-maht-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 May 2021

File name

ie-pl-pr2369122-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 June 2020

File name

ie-spc-zimovane-pr1572749-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 17 June 2020

File name

ie-pl-zimovane-pr1572749-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 18 April 2019

File name

ie-spc-zimovane-mahtransfer-clean.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 April 2019

File name

ie-spc-zimovane-mahtransfer-clean.pdf

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 March 2019

File name

ie-pl-zimovane-cmdh-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 March 2019

File name

ie-spc-zimovane-mahtransfer-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 not be renewed (A)

Updated on 14 August 2018

File name

ie-pl-zimovane-cmdh-clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 August 2018

File name

ie-spc-zimovane-cmdh-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 March 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 March 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

In section 4.1: the indication has been further expanded to include ‘in adults’

In section 4.2: Text has been added for paediatric population and that zopiclone should not be used in children and adolescents under the age of 18 years

In section 4.4: the term elderly has been changed to older patients and text added regarding paediatric population

In section 4.8: the term elderly has been changed to older patients and the ADR statement has been added

In section 10: the date of revision has changed

Updated on 06 March 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.1: the indication has been further expanded to include ‘in adults’

In section 4.2: Text has been added for paediatric population and that zopiclone should not be used in children and adolescents under the age of 18 years

In section 4.4: the term elderly has been changed to older patients and text added regarding paediatric population

In section 4.8: the term elderly has been changed to older patients and the ADR statement has been added

In section 10: the date of revision has changed

Updated on 14 January 2013

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

·         In section 6.3: the shelf-life has been reduced from 5 years to 3 years

·         In section 10: the date of revision has changed

Updated on 14 January 2013

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

·         In section 6.3: the shelf-life has been reduced from 5 years to 3 years

·         In section 10: the date of revision has changed

Updated on 09 March 2012

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

In section 6.5; the HDPE presentation has been removed
In section 10; the date of revision has changed

Updated on 09 March 2012

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.5; the HDPE presentation has been removed
In section 10; the date of revision has changed

Updated on 11 January 2012

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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

In section 3; information has been added that the tablet can be devided in equal halves
In section 10; the date of revision has changed

Updated on 11 January 2012

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 3; information has been added that the tablet can be devided in equal halves
In section 10; the date of revision has changed

Updated on 01 November 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In sesction 4.4;There is an added warning regarding somnuambulism and associated behaviours
In section 4.8; There has been additional explainations of terms added to the table of undesirable effects. There also has been the addtional of musculoskeletal and connective tiisues orders. An reference to risk of falls is also included.
In section 4.9; additional information has been added regarding overdose

Updated on 01 November 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Free text change information supplied by the pharmaceutical company

In sesction 4.4;There is an added warning regarding somnuambulism and associated behaviours
In section 4.8; There has been additional explainations of terms added to the table of undesirable effects. There also has been the addtional of musculoskeletal and connective tiisues orders. An reference to risk of falls is also included.
In section 4.9; additional information has been added regarding overdose

Updated on 26 October 2011

Reasons for updating

  • 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

In section 10; the date of revision has changed

Updated on 26 October 2011

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 10; the date of revision has changed

Updated on 07 April 2011

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

in section 2: additonal text regarding excipients have been added
in section 6.4 addtional storage information has been added
In section 7: address of MAH has changed
in section 9; the date of last renewal has been changed
in section 10: the date of revision has changed to January 2010

Updated on 07 April 2011

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition

Free text change information supplied by the pharmaceutical company

in section 2: additonal text regarding excipients have been added
in section 6.4 addtional storage information has been added
In section 7: address of MAH has changed
in section 9; the date of last renewal has been changed
in section 10: the date of revision has changed to January 2010

Updated on 20 April 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.4: Minor change to text, addition of lactose warning
Section 4.8: Addition of MedDRA table, changes to text
Section 5.1: Addition of ATC Code
Section 10: Change to revision of text

Updated on 20 April 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.4: Minor change to text, addition of lactose warning
Section 4.8: Addition of MedDRA table, changes to text
Section 5.1: Addition of ATC Code
Section 10: Change to revision of text

Updated on 25 February 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7-removal of trading style of Marketing Authorisation holder.

Updated on 25 February 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7-removal of trading style of Marketing Authorisation holder.

Updated on 04 October 2007

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 October 2007

Reasons for updating

  • New SPC for medicines.ie

Mylan IRE Healthcare Ltd

Mylan IRE Healthcare Ltd