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WHO COLLABORATING CENTRE FOR DRUG STATISTICS METHODOLOGY

To the users of the ATC/DDD system 26 November 2018

Dear all,

ATC/DDD alterations and new ATC/DDDs – valid from January 2019

Enclosed please find the lists of ATC and DDD alterations valid from January 2019. Lists of new ATC codes and new DDDs to be included in the 2019 edition of the ATC/DDD Index are also enclosed.

ATC alterations Only one ATC alteration is made. The ATC code for dimethyl fumarate is changed from N07XX09 to L04AX07 in order to cover both approved indications, i.e. multiple sclerosis and plaque psoriasis.

DDD alterations DDDs for several antibacterials for systemic use (J01) have been altered. In addition the DDD for (A04AD12) have been altered from 95 mg (O,P) to 165 mg (O) and 150 mg (P). The new DDDs are based on the single dose treatment on day one.

Updated versions of the ATC/DDD Index and the Guidelines for ATC classification and DDD assignment will be distributed in January 2019. These publications are available in English and Spanish. Please find the order form on our website www.whocc.no.

If you need further information, please feel free to contact us ([email protected]).

For your information, the next course in the ATC/DDD methodology will be arranged in Oslo 13-14 June 2019. Please see the enclosed invitation. You will be able to make your registration from February.

Yours sincerely,

Irene Litleskare

Enclosures

Postal address: Office address: Telephone: + 47 21 07 81 60 P.O.Box 222 Skøyen Sandakerveien 24C, Bygg C N-0213 Oslo N-0473 Oslo E-mail: [email protected]

ALTERATIONS IN ATC CLASSIFICATION valid from January 2019 sorted according to previous ATC code

Previous ATC code ATC level name New ATC code

N07XX09 dimethyl fumarate L04AX07

WHO Collaborating Centre for Drug Statistics Methodology Oslo, November 2018 Other alterations in ATC classification, i.e. new levels (this list includes only new levels assigned in connection with an alteration), deleted levels and altered names of ATC levels valid from January 2019 sorted according to ATC code

ATC code Previous ATC level name New ATC level name or new ATC level A12BA30 combinations potassium (different salts in combination)

C09C Angiotensin II antagonists, plain Angiotensin II receptor blockers (ARBs), plain C09CA Angiotensin II antagonists, plain Angiotensin II receptor blockers (ARBs), plain C09D Angiotensin II antagonists, combinations Angiotensin II receptor blockers (ARBs), combinations C09DA Angiotensin II antagonists and diuretics Angiotensin II receptor blockers (ARBs) and diuretics C09DB Angiotensin II antagonists and calcium Angiotensin II receptor blockers (ARBs) channel blockers and calcium channel blockers C09DX Angiotensin II antagonists, other Angiotensin II receptor blockers (ARBs), combinations other combinations D08AK04 mercurochrome merbromin

L01XC16 dinutuximab dinutuximab beta L01XC29 ermekumab bermekimab

V09IX07 fluoromethylcholine (18F) fluorocholine (18F)

WHO Collaborating Centre for Drug Statistics Methodology Oslo, November 2018 ALTERATIONS IN DDDs valid from January 2019

ATC code ATC level name - Previous DDD New DDD

A04AD12 aprepitant 1) 95 mg P 150 mg P A04AD12 aprepitant 95 mg O 165 mg O H01BA01 vasopressin (argipressin) 4 U P 40 U P J01CA01 2 g P 6 g P J01CA04 1 g O 1.5 g O J01CA04 amoxicillin 1 g P 3 g P J01CA17 2 g P 4 g P amoxicillin and beta-lactamase J01CR02 1 g O 1.5 g O inhibitor J01DE01 2 g P 4 g P J01DH02 2 g P 3 g P J01MA02 0.5 g P 0.8 g P J01XB01 3 MU P 9 MU P

1) Refers to fosaprepitant

WHO Collaborating Centre for Drug Statistics Methodology Oslo, November 2018

NEW ATC CODES valid from January 2019

ATC code ATC level name

A06AH05 naldemedine

A07XA06 crofelemer

A10BD23 metformin and ertugliflozin

A10BD24 sitagliptin and ertugliflozin

A10BD25 metformin, saxagliptin and dapagliflozin

A10BH52 gemigliptin and rosuvastatin

A10BK04 ertugliflozin

A10BK05 ipragliflozin

A16AX15 telotristat

B01AX07 caplacizumab

B02BX07 lusutrombopag

B02BX08 avatrombopag

B02BX09 fostamatinib

B03XA05 roxadustat

B06AC05 lanadelumab

C01CX09 angiotensin II

C02KX52 ambrisentan and tadalafil

C09DX05 valsartan and nebivolol

C09DX06 candesartan, amlodipine and hydrochlorothiazide

D04AX01

D10AD06 trifarotene

D11AH06 crisaborole

D11AX25 hydrogen peroxide

G01AX17 dapivirine

G02BB02 vaginal ring with progestogen

G03AA17 medroxyprogesterone and estradiol

G03AB09 norgestimate and ethinylestradiol G03XX Other sex hormones and modulators of the genital system

G03XX01 prasterone

G04CX04 fexapotide

J01AA13 eravacycline

J01DD18

J01DD64 and beta-lactamase inhibitor

J01DH06 pivoxil

J01DH52 meropenem and J01MA22 J01MA23

J04AM07 , and

J04AM08 isoniazid, , and

J05AG06 doravirine

J05AH03 peramivir

J05AP57 glecaprevir and pibrentasvir

J05AR23 atazanavir and ritonavir

J05AR24 lamivudine, tenofovir disoproxil and doravirine

J05AX17 enisamium iodide

J05AX18 letermovir

J05AX19 tilorone

J05AX21 pentanedioic acid imidazolyl ethanamide

J05AX23 ibalizumab

L01AD08 uramustine

L01BC09 floxuridine

L01XC31 avelumab

L01XC32 atezolizumab

L01XE44 lorlatinib

L01XE45 neratinib

L01XE46 encorafenib

L01XE47 dacomitinib

L01XE48 icotinib

L01XE50 abemaciclib L01XX58 epacadostat

L01XX59 enasidenib

L01XX60 talazoparib

L01XX61 copanlisib

L01XY01 cytarabine and daunorubicin

L02AE51 leuprorelin and bicalutamide

L02BB05 apalutamide

L04AA38 ozanimod

L04AA39 emapalumab

L04AA40 cladribine 1)

L04AC17 tildrakizumab

M05BB09 ibandronic acid and colecalciferol

N02CX08 galcanezumab

N03AX24 cannabidiol

N07XX12 patisiran

N07XX13 valbenazine

N07XX14 edaravone

P01CA03 fexinidazole

R03CC63 clenbuterol and ambroxol

S01EX06 omidenepag

S01XA26 riboflavin

V04CX01 indocyanine green

1) Oral formulations indicated for multiple sclerosis. Parenteral formulations are classified in L01BB04

WHO Collaborating Centre for Drug Statistics Methodology Oslo, November 2018

NEW DDDs valid from January 2019

ATC code ATC level name New DDD A04AD14 rolapitant 0.18 g O

A05AA01 chenodeoxycholic acid 1 g O

A06AH05 naldemedine 0.2 mg O

A07AA08 kanamycin 3 g O

A07AA10 colistin 9 MU O

A07DA06 eluxadoline 0.2 g O

A10AE54 insulin glargine and lixisenatide 40 U 1) P

A10BK04 ertugliflozin 10 mg O

A16AX15 telotristat 0.75 g O

B02BX06 emicizumab 15 mg P

C01CA27 droxidopa 1 g O

D11AH05 dupilumab 21.4 mg P

G02AD06 0.2 mg O

G03CA03 estradiol 1.53 mg TD spray

G03GA10 follitropin delta 12 mcg P

G04BD13 desfesoterodine 3.5 mg O

H03AA05 thyroid gland preparations 0.1 g O

J01DB11 2.1 g O

J01DD18 cefteram 0.4 g O

J01DD63 and beta-lactamase inhibitor 2 g 2) P

J01DH06 tebipenem pivoxil 0.56 g O

J01DI03 0.75 g O

J01FA03 1.2 g O

J01MA07 0.4 g O

J01MA15 0.32 g O

J01MA19 0.4 g O J01MA22 tosufloxacin 0.45 g O

J01MA23 delafloxacin 0.9 g O

J01MA23 delafloxacin 0.6 g P

J04AK06 0.2 g O

J05AC02 rimantadine 0.2 g O

J05AR23 atazanavir and ritonavir 0.3 g 3) O

J05AX17 enisamium iodide 1.5 g O

J05AX18 letermovir 0.48 g O,P

J05AX19 tilorone 0.125 g O

J05AX21 pentanedioic acid imidazolyl ethanamide 90 mg O

L04AA36 ocrelizumab 3.29 mg P

L04AA37 baricitinib 4 mg O

L04AA40 cladribine 0.34 mg O

L04AC14 sarilumab 14.3 mg P

L04AC16 guselkumab 1.79 mg P

M09AX07 nusinersen 0.1 mg P

N05AX15 cariprazine 3 mg O

P01AB07 secnidazole 2 g O

P01BD51 pyrimethamine, combinations 75 mg 4) P

P01BE02 artemether 0.28 g R

P01BE03 0.28 g R

R03DA12 mepyramine theophyllinacetate 0.6 g O

R03DX08 reslizumab 7.1 mg P

R03DX10 benralizumab 0.54 mg P

V03AE09 patiromer calcium 8.4 g O

1) refers to insulin glargine 2) refers to ceftriaxone 3) refers to atazanavir 4) refers to pyrimethamine

WHO Collaborating Centre for Drug Statistics Methodology Oslo, November 2018