Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-8096
Trade NameDose FormStrengthIdentifier
AbbapramFilm coated tablet20 mg
SponsorApplication dateRegistration situationClassification
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
P O Box 62027
Sylvia Park
AUCKLAND 1644
18/3/2008Approval lapsed
Approval date: 2/10/2008
Notification date: 23/9/2011
Prescription
 

Composition

ComponentIngredientManufacturer
film coated tabletActive 
 Citalopram hydrobromide 24.98 mg (equivalent to 20 mg citalopram)H Lundbeck A/S
Oddenvej 182
Lumsaas
Nykoebing
Sjaelland DK-4500
Denmark
 Excipient 
 Croscarmellose sodium
 Glycerol
 Hypromellose
 Lactose monohydrate
 Macrogol 400
 Magnesium stearate
 Maize starch
 Microcrystalline cellulose
 Povidone
 Titanium dioxide

Production

Manufacturing stepManufacturer
Finished Product TestingEurofins Pharma A/S
Strandesplanaden 110
Vallensbaek Strand DK-2665
Denmark
 H Lundbeck A/S
Ottiliavej 7-9
Valby DK-2500
Denmark
 Patheon France SA
40 Boulevard de Champaret
Bourgoin-Jallieu F-38317
France
 Statens Serum Institut
Artillerivej 5
Copenhagen S DK-2300
Denmark
Manufacture of Final Dose FormH Lundbeck A/S
Ottiliavej 7-9
Valby DK-2500
Denmark
 Patheon France SA
40 Boulevard de Champaret
Bourgoin-Jallieu F-38317
France
PackingFamar Italia SpA
Via Zambeletti, 25
Baranzate
Milano 20021
Italy
 Famar L'Aigle
Zone Industrielle No 1
Route de Crulai
L'Aigle 61300
France
 H Lundbeck A/S
Ottiliavej 7-9
Valby DK-2500
Denmark
 Patheon France SA
40 Boulevard de Champaret
Bourgoin-Jallieu F-38317
France
NZ Site of Product ReleaseNo site specified

Packaging

PackageContentsShelf Life
Blister pack, 28 tablets28 tablets60 months from date of manufacture stored at or below 25°C

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
12/8/2011Self-Assessable Change NotificationFinished product specifications/test methods - Grade 1 (Self assessable)Notified23/8/2011 
18/3/2008New Intermediate-risk Medicine ApplicationAdditional name - Grade 2Granted 2/10/200818/3/2008 
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