Manerix 150 mg Film-coated Tablets
*Company:
Mylan IRE Healthcare LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 May 2023
File name
Patient Information leaflet - 150 mg - PR3022176 - IE- clean-rtq.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 15 May 2023
File name
SmPC - 150 mg - PR3022176- IE - clean-rtq+excipientguideline.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 07 March 2022
File name
Patient Information leaflet - 150 mg - PR2665278 - IE- clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 28 June 2021
File name
Patient Information leaflet - 150 mg - PR2302242- IE - clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 February 2021
File name
SmPC - 150 mg - PR1659420rtq2 - IE.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 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- 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 24 February 2021
File name
Patient Information leaflet - 150 mg - PR1659420rtq1 - IE.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 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 14 June 2019
File name
ie-spc-manerix-mahtransfer-clean.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 June 2018
File name
ie-spc-manerix-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 not be renewed (A)
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 29 June 2018
File name
ie-pl-manerix-mahtransfer-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 06 May 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 May 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.2: Information regarding the posology has been updated. Method of administration has been added.
In section 5.1: The pharmacotherapeutic group has been added. The ATC code has been added.
In section 5.2: Information regarding absorption has been added. Update has been made to information regarding distribution. Information regarding metabolism and elimination has been added. Information for pharmacokinetics in special populations has been added.
In section 5.3: Preclinical safety data information has been added.
In section 10: The date of revision has been changed.
Updated on 06 May 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.2: Information regarding the posology has been updated. Method of administration has been added.
In section 5.1: The pharmacotherapeutic group has been added. The ATC code has been added.
In section 5.2: Information regarding absorption has been added. Update has been made to information regarding distribution. Information regarding metabolism and elimination has been added. Information for pharmacokinetics in special populations has been added.
In section 5.3: Preclinical safety data information has been added.
In section 10: The date of revision has been changed.
Updated on 04 November 2014
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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 4.3: Additional contraindications have been added
In section 4.4: warnings regarding the use of antidepressants in those suffering from schizophrenic and schizoaffective psychoses, the use of St John’s wart, increased risk of suicide and hyponatremia has been added
In section 4.5: Interaction with other medicinal products and other forms of interaction has been expanded.
In section 4.6: Additional information regarding pregnancy and lactation has been added
In section 4.7: Text has been reworded
In section 4.8: the structure of this section has been changed and ADR reporting has been added
In section 4.9: Information regarding the signs and management of overdose has been added
In section 10: the date of revision has changed
Updated on 04 November 2014
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.3: Additional contraindications have been added
In section 4.4: warnings regarding the use of antidepressants in those suffering from schizophrenic and schizoaffective psychoses, the use of St John’s wart, increased risk of suicide and hyponatremia has been added
In section 4.5: Interaction with other medicinal products and other forms of interaction has been expanded.
In section 4.6: Additional information regarding pregnancy and lactation has been added
In section 4.7: Text has been reworded
In section 4.8: the structure of this section has been changed and ADR reporting has been added
In section 4.9: Information regarding the signs and management of overdose has been added
In section 10: the date of revision has changed
Updated on 13 January 2012
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 been added
Updated on 13 January 2012
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 been added
Updated on 07 November 2011
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 07 November 2011
Reasons for updating
- Change to section 3 - Pharmaceutical form
Free text change information supplied by the pharmaceutical company
Updated on 18 March 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 to Feb 2011
Updated on 18 March 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 to Feb 2011
Updated on 07 January 2011
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 07 January 2011
Reasons for updating
- New SPC for medicines.ie
Free text change information supplied by the pharmaceutical company
Mylan IRE Healthcare Ltd
Address:
Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, IrelandMedical Information E-mail:
info.ie@viatris.comMedical Information Direct Line:
+44 (0)1707 853000 press 1