Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10155
Trade NameDose FormStrengthIdentifier
AlecensaCapsule150 mg
SponsorApplication dateRegistration situationClassification
Roche Products (NZ) Ltd
P O Box 109113
Newmarket
Auckland 1149
26/4/2017Consent given
Approval date: 21/12/2017
Prescription
 

Composition

ComponentIngredientManufacturer
capsuleActive 
 Alectinib hydrochloride 161.33mg equivalent to alectinib 150mgEvonik Corporation
Tippecanoe Laboratories
1650 Lilly Road
Lafayette
Indiana 47909
UNITED STATES OF AMERICA
 Excipient 
 Black ink (Alecensa)
 Carmellose calcium
 Carnauba wax
 Carrageenan
 Hyprolose
 Hypromellose
 Lactose monohydrate
 Magnesium stearate
 Maize starch
 Potassium chloride
 Sodium laurilsulfate
 Titanium dioxide

Production

Manufacturing stepManufacturer
Finished Product TestingEvonik Operations GmbH
Paul-Baumann-Strasse 1
Marl 45772
GERMANY
 F Hoffmann-La Roche Ltd
Betriebsstandort Analytiklabor Bau 250
Kaiseraugst CH-4303
SWITZERLAND
 F Hoffmann-La Roche Ltd
Betriebsstatten Kaiseraugst
Wurmisweg
Kaiseraugst CH-4303
SWITZERLAND
 F Hoffmann-La Roche Ltd
Grenzacherstrasse 124
Basel CH-4070
SWITZERLAND
Finished Product Testing - MicrobiologicalLabor LS SE & Co.KG
Mangelsfeld 4, 5, 6
Bad Bocklet
Grossenbrach 97708
GERMANY
Manufacture of Final Dose FormExcella GmbH & Co KG
Nurnberger Strasse 12
Feucht 90537
GERMANY
PackingDelpharm Milano S.r.L
Via Carnevale 1
Segrate
Milan 20054
ITALY
 F Hoffmann-La Roche Ltd
Betriebsstatten Kaiseraugst
Wurmisweg
Kaiseraugst CH-4303
SWITZERLAND
Secondary PackagingF Hoffmann-La Roche Ltd
Betriebsstatten Kaiseraugst
Wurmisweg
Kaiseraugst CH-4303
SWITZERLAND
NZ Site of Product ReleaseRoche Products (NZ) Ltd
98 Carlton Gore Road
Newmarket
Auckland 1023

Packaging

PackageContentsShelf Life
Blister pack, PA/Al - PVC/Al - component only not to be sold separately56 capsules60 months from date of manufacture stored at or below 30°C. inner carton of 56 capsules, 8 capsules per blister strip
Combination pack, four separate PA/Al - PVC/Al blister packs of 56 capsules each224 capsules60 months from date of manufacture stored at or below 30°C. tertiary pack of 224 capsules containing four inner cartons of 56 capsules, 8 capsules/blister

Indications

Alecensa is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
14/12/2023CMN 24(5)Indications/dosage - G3 (NCE)Initial evaluation21/12/2023 
26/4/2017New Higher-risk Medicine ApplicationAbridged new higher-risk medicine containing one or more new active substanceGranted 21/12/20172/6/2017 
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