Naltrexone 50 mg film-coated tablets
*Company:
AOP Orphan Pharmaceuticals GmbHStatus:
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 14 February 2025
File name
Naltrexone SPC022024.pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 September 2023
File name
Licence_PA0934-003-001_04022022105904.pdf
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
Change from AOP Orphan Pharmaceuticals AG to AOP Orphan Pharmaceuticals GmbH
Updated on 12 September 2023
File name
IE Naltrexone PIL Dec 2021.pdf
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Change from AOP Orphan Pharmaceuticals AG to AOP Orphan Pharmaceuticals GmbH
Updated on 19 July 2021
File name
IE_NTX_Naltrexone_SPC_2020.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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated wording around interactions
Updated on 19 July 2021
File name
IE_NTX_Naltrexone_PIL_2020.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Free text change information supplied by the pharmaceutical company
Updated wording and cautions regarding the use of emergency opioids
Updated on 16 January 2019
File name
IE_NTX_Naltrexone_PIL.pdf
Reasons for updating
- New PIL for new product
Updated on 05 December 2018
File name
IE_NTX_Naltrexone_SPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
AOP Orphan Pharmaceuticals GmbH
Address:
AOP Orphan, Colmore Plaza, 20 Colmore Circus Queensway, Birmingham, B4 6AT.Medical Information E-mail:
medinfo@aoporphan.comTelephone:
+44(0) 121 262 4119Fax:
+44(0) 121 566 9010Website:
https://www.aop-health.com/global_enStock Availability:
+44(0) 121 262 4119 or office.ie@aoporphan.com