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. 2022 Sep 15;2:71. Originally published 2022 Jun 1. [Version 2] doi: 10.12688/openreseurope.14129.2

Table 9. Shortlist of APIs where at least one year’s weight is 10× bigger or smaller than the mean.

API name Type Description Comments
altrenogest sex hormone veterinary birth control New formulation (“Altresyn Ceva” authorised in
Norway 2018 ( Statens legemiddelverk, 2022)
asenapine antipsychotic atypical antipsychotic for schizophrenia
and bipolar disorder
Sole product (“Syncrest”) deregistered 2017
( Felleskatalogen, 2022)
carglumic acid metabolic carbamoyl phosphate synthetase
inhibitor for hyperammonaemia
Two products, one of which (“Ucedane”) was first
authorised in June 2017 ( Felleskatalogen, 2022)
cefalotin antibacterial beta-lactam cephalosporin antibiotic Shortage of cefalotin in Norway recorded 2019
( Antibiotika.no, 2019)
cladribine antineoplastic antimetabolite and immunosuppressant
for multiple sclerosis and leukaemia
Authorised August 2017 ( Felleskatalogen, 2022)
cobimetinib antineoplastic mitogen-activated protein kinase
inhibitor for melanoma
Authorised November 2015 ( Felleskatalogen, 2022)
cyclizine antiemetic piperazine antihistamine for nausea
relief from motion sickness, vertigo
Cause of change unknown
dacarbazine antineoplastic alkylating agent for skin cancer and
lymphoma
Authorised March 2017 ( Felleskatalogen, 2022)
dasabuvir antiviral antiviral used in combination for
treatment of hepatitis C
Manufacturer withdrew application for dasabuvir/
ombitasvir/paritaprevir/ritonavir in 2016 ( Nye Metoder, 2016); however, ritonavir is also available alone
edoxaban antithrombotic Factor Xa inhibitor for clotting reduction
for strokes, atrial fibrillation, DVT
Authorised June 2015 ( Felleskatalogen, 2022)
eluxadoline antidiarrheal treatment for diarrhoea from IBS Authorised as reimbursable prescription
2017, withdrawn from market 2019 ( Statens legemiddelverk, 2017; Felleskatalogen, 2022)
fomepizole antidote antidote to methanol and antifreeze
poisoning
Cause of change unknown
gadobenic acid diagnostic agent gadolinium contrast agent used for
magnetic resonance imaging
Cause of change unknown
gadodiamide diagnostic agent gadolinium contrast agent used for
magnetic resonance imaging
Deregistered 2018 ( Felleskatalogen, 2022)
glecaprevir antiviral protease inhibitor used in combination
with pibrentasvir for hepatitis C
Glecaprevir/pibrentasvir (“Maviret”) Authorised July
2017 ( Felleskatalogen, 2022)
ixazomib antineoplastic proteasome inhibitor for multiple
myeloma
Authorised November 2016 ( Felleskatalogen, 2022)
nitrofurantoin antibacterial antibiotic for bladder infections Shortage recorded from 2018–2021 ( VG, 2019)
nystatin antifungal topical antifungal Cause of change unknown
ombitasvir antiviral antiviral taken with paritaprevir and
ritonavir for hepatitis C
See dasabuvir
osimertinib antineoplastic tyrosine kinase inhibitor for non-small
cell lung cancer
Authorised February 2016 ( Felleskatalogen, 2022)
palbociclib antineoplastic selective cyclin-dependent kinase
inhibitor for breast cancer
Authorised November 2016 ( Felleskatalogen, 2022)
paritaprevir antiviral combination treatment for hepatitis C See dasabuvir
pibrentasvir antiviral antiviral used in combination for
hepatitis C
See glecaprevir
prednisone steroid corticosteroid and immunosuppressant
for many immune and allergic disorders
Shortage recorded 2019 ( Statens legemiddelverk, 2019)
safinamide dopaminergic MAO inhibitor for Parkinson's Authorised February 2015 ( Felleskatalogen, 2022)
toceranib antibacterial receptor tyrosine kinase inhibitor for
canine cancers
Deregistered 2019 ( Felleskatalogen, 2022)
tofacitinib immunosuppressant treatment for arthritis, ulcerative colitis Authorised March 2017 ( Felleskatalogen, 2022)
velpatasvir antiviral NS5A inhibitor for hepatitis C Sofosbuvir/velpatasvir (“Epclusa”), Sofosbuvir/
velpatasvir/voxilaprevir (“Vosevi”) authorised July 2016
( Felleskatalogen, 2022)
venetoclax antineoplastic treatment for leukaemia Authorised December 2016 ( Felleskatalogen, 2022)
vinflunine antineoplastic alkaloid derivative for bladder cancer Cause of change unknown
voxilaprevir antiviral protease inhibitor for hepatitis C See velpatasvir

API, Active Pharmaceutical Ingredient; DVT, deep vein thrombosis; IBS, irritable bowel syndrome; MAO, monoamine oxidase; NS5A, nonstructural protein 5A.