Revestive - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

teduglutide

Opinion

On 26 April 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Revestive. The marketing authorisation holder for this medicinal product is Takeda Pharmaceuticals International AG Ireland Branch.

The CHMP adopted an extension to the existing indication as follows:¹

Revestive is indicated for the treatment of patients 4 months corrected gestational age 1 year and above with Short Bowel Syndrome (SBS). Patients should be stable folllowing a period of intestinal adaptation after surgery.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

---

¹ New text in bold, removed text as strikethrough

 

CHMP post-authorisation summary of opinion for Revestive (II-54-G)

AdoptedReference Number: EMA/177909/2023

Key facts

• Name of medicine:
  Revestive
• EMA product number:
  EMEA/H/C/002345
• Active substance:
  teduglutide
• International non-proprietary name (INN) or common name:
  teduglutide
• Therapeutic area (MeSH):
  Malabsorption Syndromes
• Anatomical therapeutical chemical (ATC) code:
  A16AX08
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Takeda Pharmaceuticals International AG Ireland
• Date of opinion:
  26/04/2023
• Status:
  Positive