OxyNorm 5mg capsules
*Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
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 23 May 2024
File name
Proposed_IE_SmPC_OxyNorm_Capsules_5mg_PSUSA-00002254-202304_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 May 2024
File name
Proposed_IE_PIL_OxyNorm_Capsules_5-10-20mg_PSUSA-00002254-202304_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 December 2023
File name
OxyNorm 5 mg Capsules SPC IE- clean.pdf
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
- 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
Updated to implement the outcome of an Article 45 procedure FR/W/0010/pdWS/01.
Amendments made to include the text concerning the addition of the paediatric indication in the paediatric subset 12 to 18 years of age.
Updated on 14 December 2023
File name
OxyNorm Capsules PIL - Ireland_clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
Free text change information supplied by the pharmaceutical company
Updated to implement the outcome of an Article 45 procedure FR/W/0010/pdWS/01.
Amendments made to include the text concerning the addition of the paediatric indication in the paediatric subset 12 to 18 years of age.
Updated on 08 August 2023
File name
OxyNorm 5 mg Capsules SPC - IE-clean.pdf
Reasons for updating
- 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
- 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
section 4
Updated on 08 August 2023
File name
OxyNorm Capsules PIL -IE-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
Updated on 30 March 2023
File name
OxyNorm 5 mg Capsules SPC-IE-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to IE MAH address
Updated on 30 March 2023
File name
OxyNorm Capsules PIL-IE-clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Change to IE MAH address