Pursuant to section 106(1) of the Medicines Act 1981, I, Chris James, Group Manager, Medsafe, Ministry of Health, acting under delegated authority, hereby declare the following:

1. The medicines listed in Schedule 1 to this notice are classified as prescription medicines.
2. The medicines listed in Schedule 2 to this notice are classified as restricted medicines.
3. The medicines listed in Schedule 3 to this notice are classified as pharmacy-only medicines.

Every reference to a medicine in this notice applies whether the medicine is synthetic in origin or is from biological or mineral sources.

Unless specific reference is made otherwise, every reference applies also to medicines that are:

1. preparations and admixtures containing any proportion of any substance listed in the notice.
2. salts and esters of any substance listed in the notice.
3. preparations or extracts of biological materials listed in the notice.
4. salts or oxides of elements listed in the notice.

Unless specific reference is made otherwise, every reference to a medicine applies:

1. if the medicine is in an injection or eye preparation, to any concentration of that medicine; and
2. if the medicine is not in an injection or eye preparation, only if the concentration of the medicine is greater than 10 milligrams per litre or per kilogram.

Where any reference is modified by a statement of the strength of the medicine, the strength is calculated using the free acid, base, alcohol or element unless specifically stated otherwise.

Schedule 1

Prescription Medicines

Bezlotoxumab

Brexpiprazole

Ceritinib

Emicizumab

Evolocumab

Dupilumab

Fosfomycin

Guanfacine

Migalastat

Panobinostat

Patent blue V; for injection when used in diagnostic procedures

Penciclovir; except when specified elsewhere in this notice

Sebelipase alfa

Silodosin

Teduglutide

Tianeptine

Schedule 2

Restricted Medicines

Hydrocortisone and hydrocortisone acetate but no other esters of hydrocortisone; for dermal use in medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base with no other active ingredient except an antifungal and in a quantity of 30 grams or less or 30 millilitres or less per container; for dermal use in medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base with no other active ingredient except 5% or less by weight of aciclovir and in a quantity of 2 grams or less or 2 millilitres or less per container in adults and children 12 years of age and older; in rectal medicines containing 1% or less but more than 0.5% by weight of hydrocortisone base and in combination with a local anaesthetic and in a quantity of 35 grams or less per container or up to 12 suppositories per pack

Schedule 3

Pharmacy-only Medicines

Penciclovir; for external use for the treatment of herpes labialis; except in medicines for external use containing 1% or less in a pack containing 10g or less for the treatment of herpes labialis

Medicines for General Sale

Please note that the following medicines are now available for general sale

Penciclovir; for external use containing 1% or less in a pack containing 10g or less for the treatment of herpes labialis

Dated this 14th day of March 2018.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health.