Medsafe: New Zealand Medicines and Medical Devices Safety Authority

MEDSAFE


New Zealand Medicines and Medical
Devices Safety Authority

Revised: 26 August 2026

Medicines

 

Medsafe Product Detail

CMICMI
File ref: TT50-4946
Trade Name Dose Form Strength Identifier
Addaven Solution for infusion .
Sponsor Application date Regulatory status Classification
Fresenius Kabi New Zealand Limited
c/o GNZCC
HSBC Tower, Level 14
188 Quay Street
Auckland 1010
27/08/1990 Consent given
Approval date:17/10/1991
General sale

Composition

Component Ingredient Manufacturer
solution for infusion, Up to 19 December 2014Active 
 Chromium trichloride hexahydrate 5.33 µg/mLMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
  ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 Copper chloride dihydrate 0.34 mg/mLMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
  ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 Ferric chloride hexahydrate 0.54 mg/mLMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
  ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 Manganese chloride tetrahydrate 99 µg/mLMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
  ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 Potassium iodide 16.6 µg/mLMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Sodium fluoride 0.21 mg/mLMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Sodium molybdate dihydrate 4.85 µg/mLMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
  ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 Sodium selenite 10.5 µg/mLMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
  Retorte GmbH Selenium Chemicals & Metals
Sulzbacher Strasse 45
Rothenbach D-90552
GERMANY
  ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 Zinc chloride 1.36 mg/mLMerck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
  ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
  Merck Life Science Technologies (Nantong) Co., Ltd
No. 39 Jianggang Road
NETDA
Nantong, Jiangsu 226 017
CHINA
 Excipient 
 Hydrochloric acid
 Water for injection
 Xylitol
solution for infusion, From 19 December 2014Active 
 Chromium trichloride hexahydrate 5.33 µg/mL
 Copper chloride dihydrate 102.3 µg/mL
 Ferric chloride hexahydrate 540 µg/mL
 Manganese chloride tetrahydrate 19.79 µg/mL
 Potassium iodide 16.6 µg/mL
 Sodium fluoride 210 µg/mL
 Sodium molybdate dihydrate 4.85 µg/mL
 Sodium selenite 17.29 µg/mL
 Zinc chloride 1050 µg/mL
 Excipient 
 Hydrochloric acid
 Water for injection
 Xylitol

Production

Manufacturing step Manufacturer
Finished Product TestingHP Halden Pharma AS
Svinesundveien 80
Halden NO-1788
NORWAY
Manufacture of Active IngredientChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 ChemCon GmbH
Engesserstrasse 4B
Freiburg im Breisgau D-79108
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck KGaA
Frankfurter Strasse 250
Darmstadt 64293
GERMANY
 Merck Life Science Technologies (Nantong) Co., Ltd
No. 39 Jianggang Road
NETDA
Nantong, Jiangsu 226 017
CHINA
 Retorte GmbH Selenium Chemicals & Metals
Sulzbacher Strasse 45
Rothenbach D-90552
GERMANY
Manufacture of Final Dose FormHP Halden Pharma AS
Svinesundveien 80
Halden NO-1788
NORWAY
PackingFresenius Kabi AB
Rapsgatan 7
Uppsala SE-751 74
SWEDEN
Secondary PackagingPharmaco (NZ) Ltd
4 Fisher Crescent
Mt Wellington
AUCKLAND 1060
NZ Site of Product ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

Package Contents Shelf life
Ampoule, plastic, 10ml polypropylene single dose amp20 dose units36 months from date of manufacture stored at or below 30°C
24 hours opened stored at or below 25°C

Indications

To meet basal to moderately increased requirements of trace elements in parenteral nutrition in adults and children weighing 15 kg and over, when either oral or enteral nutrition is inappropriate

Latest Regulatory Activity

Application DateApplication TypeChange(s)StatusPayment DatePriority
13/01/2026Changed Medicine NotificationExcipient specifications/test methods - G2; Finished product manufacture - G1; Editorial updates to Module 3 documentsGranted30/01/2026