OxyNorm Dispersa 10 mg orodispersible tablets

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Pharmacy Only: Prescription

Updated on 06 March 2024

File name

OxyNorm Dispersa 10 mg-SPC-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 06 March 2024

File name

OxyNorm Dispersa 5-10-20 mg-PIL-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 14 December 2023

File name

OxyNorm Dispersa 10 mg-SPC-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 Dispersa 5-10-20 mg-PIL-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 - contraindications
  • Change to section 3 - use in children/adolescents

Free text change information supplied by the pharmaceutical company

Update to PIL 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 09 May 2023

File name

OxyNorm Dispersa 10 mg-SPC-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)

Updated on 09 May 2023

File name

OxyNorm Dispersa 5-10-20 mg-PIL-clean.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 30 March 2023

File name

oxynorm dispersa-10mg-spc-clean.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 30 March 2023

File name

oxynorm dispersa-5-10-20mg-pil-clean.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

IE MAH Address Change

Updated on 30 March 2023

File name

oxynorm dispersa-10mg-spc-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

IE MAH Address Change