Working Minutes of the Ephmra Classification Committee

EphMRA Classification Committee August 2017

Provisional 2018 EphMRA ATC Developments

The following new class structures were voted on by EphMRA/PBIRG in May/June 2017 and agreed in principle. These structures will now be used in the next part of the development process which is the detailed refinement of the rules.

Please note that these new class structures are provisional at this time. The 2018 codes, descriptions and Guideline text will be finalised and published by the Committee at the end of 2017. The new structures then come into effect from the beginning of 2018.

Other stomach disorder products

A2C OTHER STOMACH DISORDER PREPARATIONS (deleted) A2X OTHER STOMACH DISORDER PRODUCTS (new)

Other bile therapy and cholagogues

A5A BILE THERAPY AND CHOLAGOGUES

A5A1 Choleretics and cholekinetics

A5A2 Bile stone therapy

A5A9 Other bile therapy and cholagogues (new)

Other fluoroquinolones

J1G FLUOROQUINOLONES

J1G1 Oral fluoroquinolones

J1G2 Injectable fluoroquinolones

J1G9 Other fluoroquinolones (new)

Includes inhaled forms of fluoroquinolones.

Hepatitis antivirals

J5B1 Viral hepatitis products (deleted)

J5D HEPATITIS ANTIVIRALS (new)

Includes products for viral hepatitis. Products containing interferons that are indicated for viral hepatitis only are classified here.

©EphMRA 2017 Page 1

EphMRA Classification Committee August 2017

J5D1 Hepatitis B and hepatitis C antivirals (new)

Includes products for both hepatitis B and hepatitis C. For example, products containing interferons or ribavarin, and indicated for both hepatitis B and hepatitis C.

J5D2 Hepatitis B antivirals (new)

Products containing adefovir dipivoxil, clevudine, entecavir, lamividune, telbivudine, and for hepatitis B only, are classified here.

J5D3 Hepatitis C antivirals (new)

Products containing asunaprevir, boceprevir, elbasvir, daclatasvir, dasabuvir, grazoprevir, ledipasvir, narlaprevir, ombitasvir, paritaprevir, simeprevir, sofosbuvir, telaprevir, vaniprevir, and for hepatitis C only, are classified here. Combinations of antiviral substances for hepatitis C only are classified here.

J5D9 Hepatitis antivirals, other (new)

Includes other products for viral hepatitis.

Protozoal vaccines

J7F PROTOZOAL VACCINES (new)

Includes vaccines against one protozoal group. For vaccines against a combination of organisms, see J7B.

J7F1 Malaria vaccines (new)

J7F9 All other protozoal vaccines (new)

Proteasome inhibitor antineoplastics

L1J PROTEASOME INHIBITOR ANTINEOPLASTICS (new) Includes products containing proteasome inhibitors (for example bortezomib, carfilzomib, ixazomib) and indicated for cancer.

HDAC inhibitor antineoplastics

L1X3 HDAC inhibitor antineoplastics (new) Includes products containing HDAC inhibitors (for example belinostat, panobinostat, romidepsin, tucidinostat, vorinostat) and indicated for cancer.

Photosensitisers for cancer therapy

L1X8 Photosensitisers for cancer therapy (new) Includes products containing photosensitisers (for example aminolaevulinic acid, methyl aminolaevulinate, porfimer, talaporfin, temoporfin) and indicated for use in cancer therapy.

Interleukin inhibitor anti-asthmatics

R3M INTERLEUKIN INHIBITOR ANTI-ASTHMATICS (new) Products containing interleukin inhibitors (for example, mepolizumab, reslizumab) and indicated only for asthma, are classified here.