Decision: Orphan registered medicinal products

A list of authorised orphan medicinal products registered by the UK licensing authority.

This file may not be suitable for users of assistive technology.

This file may not be suitable for users of assistive technology.

Under regulation 58D of the Human Medicines Regulations 2012 (as amended), a period of 10 years orphan market exclusivity is awarded from the date of marketing authorisation by MHRA. An additional 2 years of exclusivity may be added where paediatric data requirements have been met.

This is in accordance with regulation 58C(2) of the Human Medicines Regulations 2012 (as amended).

The scope of orphan market exclusivity is defined by the authorised indication.

Products with an orphan designation in the EU can be considered for a Great Britain orphan marketing authorisation.

A UK-wide orphan marketing authorisation can only be considered in the absence of an active EU orphan designation.

There is no pre-authorisation orphan designation in Great Britain.

An orphan designation effective in Great Britain or UK is reflected in PLGB or PL, respectively, in the orphan designation number.

Expired Orphan Register updated to add expiry date amendment for Vimizim from 30/04/2024 to 02/10/2025.

Addition of Romvimza (14mg, 20mg and 30mg capsules) OD1

Updated Orphan Register to include: 'Addition of IMCIVREE OD3'

Updated 'Orphan register' to reflect: Amendment of Takhzyro 300 mg from PLGB 54937/0028/OD1 to PL 54937/0028/OD1.