Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

File ref: TT50-3711b
Trade NameDose FormStrengthIdentifier
Gastrolyte Electrolyte HydrationPowder for oral solution.
SponsorApplication dateRegistration situationClassification
sanofi-aventis new zealand limited
P O Box 12851
Penrose
AUCKLAND 1642
5/12/1989Approval lapsed
Approval date: 5/4/1990
General sale
 

Composition

ComponentIngredientManufacturer
powder for oral solutionActive 
 Glucose monohydrate 3.56 gTEREOS Starch & Sweeteners IBERIA SAU
Avenida Salvador Allende 76-78
Zaragoza 50015
SPAIN
  Cargill SLU
C/Marie Curie 6
Barcelona 08760
SPAIN
  Tate & Lyle
Tunnel Refinneries
Aalst
BELGIUM
 Potassium chloride 0.3 gK+S Minerals and Agriculture GmbH
Plant Werra, Site Wintershall, In der Aue
Heringen
Werra 36266
GERMANY
  Klinge Chemicals Ltd
5 - 7 Albion Way
Kelvin Industrial Estate
East Kilbride
Glasgow G750YN
UNITED KINGDOM
 Sodium acid citrate 0.53 gDr Paul Lohmann GmbH KG
Hauptstrasse 2
Emmerthal 31860
GERMANY
 Sodium chloride 0.47 gDansk Salt A/S
Hadsundvej 17
Mariager 9550
DENMARK
  Sudwestdeutsche Salzwerke AG
Saline Bad Friedrichshall
Bergrat-Bilfinger-Strasse 3
Bad Friedreichshall 74177
GERMANY
 Excipient 
 Hydrated silica
 Orange flavour
 Saccharin sodium

Production

Manufacturing stepManufacturer
Finished Product TestingA Nattermann & Cie GmbH
Nattermannallee 1 Koln 50829
GERMANY
 Aspen Pharma Pty Ltd
96 Merrindale Drive
Croydon
VIC 3136
AUSTRALIA
 Phytolab GmbH & Co. KG
Dutendorferstr. 5-7
Vestenbergsgreuth 91487
GERMANY
Manufacture of Final Dose FormA Nattermann & Cie GmbH
Nattermannallee 1 Koln 50829
GERMANY
PackingA Nattermann & Cie GmbH
Nattermannallee 1 Koln 50829
GERMANY
Secondary PackagingContract Pharmaceutical Services of Australia Pty Ltd
5 Eden Park Drive
North Ryde
NSW 2113
AUSTRALIA
 DHL Exel Supply Chain (Australia) Pty Ltd
16 Picrite Close
Greystanes
NSW 2145
AUSTRALIA
 DHL Exel Supply Chain (Australia) Pty Ltd
227 Walters Road
Arndell Park
NSW 2148
AUSTRALIA
 DHL Exel Supply Chain (Australia) Pty Ltd
52 Holbeche Rd
Arndell Park
NSW 2148
AUSTRALIA
 DHL Exel Supply Chain (Australia) Pty Ltd
52 Huntingwood Drive
Huntingwood
New South Wales 2148
AUSTRALIA
 Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022
NZ Site of Product ReleaseNo site specified

Packaging

PackageContentsShelf Life
Sachet, laminate, orange flavour, sample pack- 5g 2 dose units36 months from date of manufacture stored at or below 25°C
Sachet, laminate, orange flavour,5g10 dose units36 months from date of manufacture stored at or below 25°C

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
28/10/2020CMN 24(5)Active ingredient specifications/test methods - Grade 3; Finished product packing site - Grade 2Withdrawn 4/10/202116/9/2021 
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