TRANSTEC® 35 micrograms/h Transdermal Patch

*
Pharmacy Only: Prescription
  • Company:

    Grunenthal Pharma Ltd.
  • Status:

    Updated
  • Legal 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 18 December 2024

File name

ie-pl-transtec-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 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

HPRA approval to update the product information (SmPC and PIL) for all the Transtec products following buprenorphine PSUSA outcome EMEA/H/C/PSUSA/00000459/202309. 

Updated on 18 December 2024

File name

ie-spc-transtec-35-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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

HPRA approval to update the product information (SmPC and PIL) for all the Transtec products following buprenorphine PSUSA outcome EMEA/H/C/PSUSA/00000459/202309. 

Updated on 22 May 2023

File name

ie-spc-transtec-35-clean.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 May 2023

File name

ie-pl-transtec-clean.pdf

Reasons for updating

  • New PIL for new product