Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-6753
Trade NameDose FormStrengthIdentifier
Primidone (Clinect)Tablet250 mg
SponsorApplication dateRegistration situationClassification
Clinect NZ Pty Limited
c/- Ebos Group Limited
108 Wrights Road
Christchurch 8024
31/5/2001Consent given
Approval date: 2/8/2012
Prescription
Reference product: Mysoline Tablet 250 mg

Composition

ComponentIngredientManufacturer
tabletActive 
 Primidone 250 mgNantong Jinghua Pharmaceutical Co., Ltd.
No. 20, 3 Haibin Road
Yanhai Economic Development Zone
Rudong, Nantong
Jiangsu 226407
China
 Excipient 
 Colloidal silicon dioxide
 Croscarmellose sodium
 Magnesium stearate
 Methylcellulose

Production

Manufacturing stepManufacturer
Finished Product TestingApotex Inc
150 Signet Drive
Weston
Ontario M9L 1T9
Canada
 Apotex Inc
380 Elgin Mills Road East
Richmond Hill
Ontario L4C 5H2
Canada
 Apotex Inc
50 Steinway Boulevard
Etobicoke
Ontario M9W 6Y3
Canada
Manufacture of Final Dose FormApotex Inc
150 Signet Drive
Weston
Ontario M9L 1T9
Canada
OverlabellingDHL Supply Chain (New Zealand) Ltd
30 Airpark Drive
Mangere
Auckland 2022
 DHL Supply Chain (New Zealand) Ltd
6 Manu Tapu Drive
Mangere
Auckland 2022
PackingApotex Inc
4100 Weston Road
Weston
Ontario M9L 2Y6
Canada
 Apotex Inc
50 Steinway Boulevard
Etobicoke
Ontario M9W 6Y3
Canada
NZ Site of Product ReleaseApotex NZ Ltd
Level 2, Tamariki House
Tamariki Avenue
Orewa
AUCKLAND 0931

Packaging

PackageContentsShelf Life
Bottle, plastic, HDPE/white PP cap/Al seal100 tablets60 months from date of manufacture stored at or below 25°C
Bottle, plastic, HDPE/blue PP cap/Al seal100 tablets60 months from date of manufacture stored at or below 25°C
Bottle, plastic, HDPE/white PP cap/Al foil seal500 tablets60 months from date of manufacture stored at or below 25°C
Bottle, plastic, HDPE/blue PP cap/Al foil seal500 tablets60 months from date of manufacture stored at or below 25°C

Indications

Indicated for the management of grand mal epilepsy

Indicated for the management of psychomotor (temporal lobe) epilepsy

Is also of value in the management of Jacksonian seizures

Is also of value in the management of focal seizures

Is also of value in the management of myoclonic jerks

Is also of value in the management of akinetic attacks

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
8/11/2021Self-Assessable Change NotificationFinished product specifications/test methods - Grade 1 (Self assessable)Notified16/11/2021 
6/12/2011New Intermediate-risk Medicine ApplicationNew intermediate-risk prescription medicineGranted 2/8/201216/12/2011 
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