Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-7756/2a
Trade NameDose FormStrengthIdentifier
Arrow - Bendrofluazide 2.5Tablet2.5 mg
SponsorApplication dateRegistration situationClassification
Teva Pharma (New Zealand) Limited
P O Box 128 244
Remuera
Auckland 1541
3/6/2009Consent given
Approval date: 10/12/2009
Prescription
Reference product: Neo Naclex Tablet 2.5 mg

Composition

ComponentIngredientManufacturer
tabletActive 
 Bendroflumethiazide 2.5 mgIpca Laboratories Limited
Sejavta
District Ratlam
Madhya Pradesh 457 002
India
  Unichem Laboratories Ltd
Plot No. 99, MIDC Area
Dhatav-Roha
Dist: Raigad 402 116
India
  Dipharma Francis Srl
Via Origgio 23
Caronno Pertusella (Varese)
Milan 21042
Italy
 Excipient 
 Lactose
 Purified talc
 Starch
 Stearic acid

Production

Manufacturing stepManufacturer
Finished Product TestingIpca Laboratories Limited
Plot No 255/1
Athal
Silvassa
Dadra and Nagar Haveli (U T) 396 230
India
Manufacture of Final Dose FormIpca Laboratories Limited
Plot No 255/1
Athal
Silvassa
Dadra and Nagar Haveli (U T) 396 230
India
PackingIpca Laboratories Limited
Plot No 255/1
Athal
Silvassa
Dadra and Nagar Haveli (U T) 396 230
India
NZ Site of Product ReleaseTeva Pharma (New Zealand) Limited
Level 14, 41 Shortland Street
Auckland 1010

Packaging

PackageContentsShelf Life
Blister pack, PVD/PVDC,14 tablets24 months from date of manufacture stored at or below 25°C
Blister pack, PVD/PVDC,28 tablets24 months from date of manufacture stored at or below 25°C
Bottle, plastic, HDPE, 500 tablets24 months from date of manufacture stored at or below 25°C
Bottle, plastic, HDPE,1000 tablets24 months from date of manufacture stored at or below 25°C

Indications

Bendrofluazide is indicated in the treatment of oedema associated with conditions such as: congestive heart failure, nephrotic syndrome and cirrhosis of the liver.

Bendrofluazide is also indicated in the treatment of essential hypertension where it may be used as the sole antihypertensive agent, or as an adjunct to other medicines whose action it potentiates.

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
15/5/2019Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified27/5/2019 
3/6/2009New Intermediate-risk Medicine ApplicationAdditional name - Grade 1; Additional strength - Grade 1Granted 10/12/20093/6/2009 
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