Formulary Group work programme
Forthcoming submissions 2014
This list is indicative and may be subject to change.
Aripiprazole - SMC 891/13 - in progress. (This SMC advice relates to an extension of the marketing authorisation for treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older).
Fluocinolone acetonide (Iluvien®) - SMC 864/13 - in progress. (Indication: treatment of vision impairment associated with chronic diabetic macular oedema, considered insufficiently responsive to available therapies).
Mannitol (Bronchitol®) - SMC 837/13 - in progress (Indication: treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care).
Nalmefene - SMC 917/13 - in progress (Indication: for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms, and who do not require immediate detoxification).
Timolol eye gel (Tiopex®) - SMC 941/14 - in progress (Indication: reduction of the elevated intraocular pressure in patients with: ocular hypertension / chronic open angle glaucoma).
Trastuzumab (Herceptin®) - SMC 928/13 - in progress (Indication: treatment of adult patients with HER2 positive metastatic breast cancer (MBC) and early breast cancer (EBC) in a range of settings (full details of licensed indication presented later in advice document).