Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-7099
Trade NameDose FormStrengthIdentifier
StromectolTablet3 mg
SponsorApplication dateRegistration situationClassification
Merck Sharp & Dohme (New Zealand) Limited
P O Box 99851
Newmarket
Auckland 1149
2/7/2003Consent given
Approval date: 18/8/2005
Prescription
 

Composition

ComponentIngredientManufacturer
tabletActive 
 Ivermectin 3 mgHovione PharmaScience Limited
Estrada Coronel Nicolau de Mesquita
Taipa
Macau
  MSD International GmbH (Puerto Rico Branch) LLC
Route No 2, Km 56.7
Barceloneta 00617
Puerto Rico
 Excipient 
 Butylated hydroxyanisole
 Citric acid
 Magnesium stearate
 Microcrystalline cellulose
 Starch

Production

Manufacturing stepManufacturer
Finished Product TestingMerck Sharp & Dohme BV
Waarderwag 39
Haarlem 2003 PC
Netherlands
 Merck Sharp & Dohme Limited
Shotton Lane
Cramlington
Northumberland NE23 3JU
United Kingdom
Manufacture of Final Dose FormMerck Sharp & Dohme BV
Waarderwag 39
Haarlem 2003 PC
Netherlands
PackingMerck Sharp & Dohme BV
Waarderwag 39
Haarlem 2003 PC
Netherlands
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Blister pack, Aluminium foil4 tablets24 months from date of manufacture stored at or below 30°C
Blister pack, Aluminium foil20 tablets24 months from date of manufacture stored at or below 30°C

Indications

· Treatment of intestinal strongyloidiasis (anguillulosis).
· Treatment of proven suspected microfilaraemia in patients with lymphatic filariasis caused by Wuchereria bancrofti.
· Treatment of human sarcoptic scabies after prior treatment has failed. Treatment is justified when the diagnosis of scabies has been established clinically and/or by parasitological examination. Without formal diagnosis, treatment is not justified in case of pruritus.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
27/8/2019Changed Medicine NotificationActive ingredient manufacturing process - Grade 3Initial evaluation29/8/2019 
0 1 2 4 5 6 7 9 [ /