Molaxole powder for oral solution
*Company:
Mylan IRE Healthcare LtdStatus:
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 03 July 2023
File name
ie-pl-dk1199-PR3083492-maht-MA withdrawal update-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 03 July 2023
File name
ie-spc-dk1199-PR3083492-maht-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 October 2022
File name
ie-pl-dk1199-TIIv43-clean.pdf
Reasons for updating
- 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 6 - date of revision
Updated on 25 October 2022
File name
ie-spc-dk1199-TIIv43-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 be renewed (B)
Updated on 10 September 2020
File name
ie-spc-dk1199-v040-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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 September 2020
File name
ie-pl-dk1199-v040-clean.pdf
Reasons for updating
- 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 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 23 January 2020
File name
ie-pl-dk1199-v038-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to product name
Free text change information supplied by the pharmaceutical company
Change of invented name of medicinal product in Poland
Updated on 30 August 2019
File name
ie-pl-dk1199-v036rtq-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - excipient warnings
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 30 August 2019
File name
ie-spc-dk1199-v036-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 June 2019
File name
ie-spc-molaxole-mahtransfer-clean.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 November 2018
File name
ie-pl-dk1199-ia035g-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 23 August 2018
File name
Update Molaxole PIL.pdf
Reasons for updating
- Change to section 6 - what the product contains
Updated on 02 July 2018
File name
Molaxole PIL - MAH Transfer - May 2018 - clean.pdf
Reasons for updating
- New PIL for new product
Updated on 02 July 2018
File name
ie-spc-molaxole-mahtransfer-clean.docx
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)
Free text change information supplied by the pharmaceutical company
Marketing Authorisation Holder Transfer from Meda Health Sales Ireland Limited to Mylan IRE Healthcare Limited
Updated on 10 April 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 April 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2: Minor text change
Section 3: Description of capsule has been reworded
Section 4.2: Method of administration has been added
In section 4.3: Intestinal obstruction has been added as a contraindication
In section 4.4: Text has been removed
In section 4.5: Information regarding that no interaction studies have been performed
In section 4.6: Text has changed to refer to pregnancy and lactation being not recommended rather than contraindicated
In section 4.7: Information regarding Spasmonal causing dizziness has been added and not to drive and/or operate machinery if affected
In section 4.8: Side effects have been restructured into system organ classes and frequency. Additional side effects have been added. Adverse reaction statement has been added.
In section 4.9: Information regarding fatality with very high doses have been added
In section 5.1: The Pharmacotherapeutic group and ATC code has been added
In section 10: The date of revision has been changed
Updated on 10 April 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- 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 2: Minor text change
Section 3: Description of capsule has been reworded
Section 4.2: Method of administration has been added
In section 4.3: Intestinal obstruction has been added as a contraindication
In section 4.4: Text has been removed
In section 4.5: Information regarding that no interaction studies have been performed
In section 4.6: Text has changed to refer to pregnancy and lactation being not recommended rather than contraindicated
In section 4.7: Information regarding Spasmonal causing dizziness has been added and not to drive and/or operate machinery if affected
In section 4.8: Side effects have been restructured into system organ classes and frequency. Additional side effects have been added. Adverse reaction statement has been added.
In section 4.9: Information regarding fatality with very high doses have been added
In section 5.1: The Pharmacotherapeutic group and ATC code has been added
In section 10: The date of revision has been changed
Updated on 25 June 2013
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of renewal of authorisation
- 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
In section 4.6: There has been changes to this section including an additional sub-section added for lactation and changes are also made to the sub-section regarding fertility.
In section 4.8: There has been a large change to this section with additional information added to side effects.
In section 9: the date of last renewal has been added.
In section 10: the date of revision has been changed.
Updated on 25 June 2013
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.6: There has been changes to this section including an additional sub-section added for lactation and changes are also made to the sub-section regarding fertility.
In section 4.8: There has been a large change to this section with additional information added to side effects.
In section 9: the date of last renewal has been added.
In section 10: the date of revision has been changed.
Updated on 19 June 2012
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 4.6 - Pregnancy and lactation
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.5: Additional infromation has been added re abosrption of other medicinal products and Molaxole
In section 4.6; Fertility information and heading has been added
In section 4.8; small errors have been corrected in the table
In section 10; the date of revision has changes
Updated on 19 June 2012
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.5: Additional infromation has been added re abosrption of other medicinal products and Molaxole
In section 4.6; Fertility information and heading has been added
In section 4.8; small errors have been corrected in the table
In section 10; the date of revision has changes
Updated on 30 March 2011
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
In section 7: the address of the MAH has changed
Updated on 30 March 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
In section 7: the address of the MAH has changed
Updated on 11 January 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 11 January 2011
Reasons for updating
- New SPC for new product