This section contains archived copies of letters sent to healthcare professionals by
the therapeutic products industry. Please note that the information contained in these
letters may have been superseded. Check the product information for your medicine or
medical device for the current known safety information.
| Date sent |
Product |
Reason |
| 18 November 2024 |
Naprogesic (PDF 170 KB, 1 page) |
Reclassification of naproxen – 6 month extension for Naprogesic from published
dates |
| 4 November 2024 |
Isotretinoin (PDF 165 KB, 2 pages) |
Safety information for isotretinoin prescribers |
| 1 November 2024 |
Noriday (PDF 147 KB, 1 page) |
Noriday tablets (Norethisterone 0.35mg, 3 x 28 tablet blister pack) –
supply of UK pack |
| 28 October 2024 |
Ferinject (PDF 354 KB, 2 pages) |
Ferinject (ferric carboxymaltose) 50 mg/mL solution for injection -
Interim Packaging |
| 16 October 2024 |
Alyacen (PDF 354 KB, 3 pages) |
Unavailability of BREVINOR-1® 28 Day (Ethinylestradiol 35 micrograms
and Norethisterone 1 milligram) tablets and alternative supply arrangement
under Provisional Consent for ALYACEN 1/35 (Norethindrone and Ethinyl
Estradiol Tablets USP, 1 mg/0.035 mg). |
| 25 September 2024 |
Lyllana (PDF 164 KB, 2 pages) |
Lyllana (estradiol) Transdermal Patches (0.025 mg/day, 0.05 mg/day,
0.075 mg/day, 0.1 mg/day ) have been granted provisional consent by
Medsafe |
| 16 September 2024 |
Versacloz (PDF 351 KB, 1 page) |
Versacloz (clozapine) 50mg/mL oral suspension syringe change |
| 2 September 2024 |
Copaxone (PDF 406 KB, 3 pages) |
Copaxone (Glatiramer acetate) 20 mg/mL and 40 mg/mL – Long term
anaphylactic reactions |
| 22 May 2024 |
ClopineCENTRAL (PDF 442 KB, 2 pages) |
Update related to the recent migration to ClopineCentral® 2.0 |
| 17 May 2024 |
Phenergan (PDF 88 KB, 4 pages) |
Restriction of oral formulation use in children less than 6 years
of age (new contraindication, adverse events, warnings/precautions, and
overdose in the Product Information). |
| 2 May 2024 |
Paracetamol Kabi (PDF 115 KB, 2 pages) |
Shortage of PARACETAMOL KABI 1000mg/100mL solution for injection vial and
Temporary supply of UK Labelled Product |
| 24 April 2024 |
Oramorph (Clinect) (PDF 242 KB, 1 page) |
Supply of provisionally approved Oramorph 10 mg/5 mL to address supply
shortage of morphine hydrochloride oral solution |
| 5 March 2024 |
Dexmedetomidine Viatris (PDF 204 KB, 1 page) |
Due to a shortage of Dexmedetomidine Viatris 200 mcg/2 mL, concentrate
for infusion a labelling exemption has been approved by Medsafe to allow the
supply of Dexmedetomidine Mylan 200 mcg/2 mL, concentrate for infusion from
Australia |
| 5 March 2024 |
Rocuronium bromide (Hameln) (PDF 427 KB, 3 pages) |
Supply of Croatian/Slovenian labelled Rocuronium bromide (Hameln) Solution
for injection 10 mg/mL |
| 12 February 2024 |
Bexsero (PDF 262 KB, 2 pages) |
BEXSERO vaccine will be supplied as a single-dose in a UK pack |
| February 2024 |
Coversyl (PDF 457 KB, 4 pages) |
|
| 23 January 2024 |
Paxlovid (PDF 630 KB, 7 pages) |
Transition to New Zealand packaging, updates to the contraindications
section of the data sheet and dosing instructions for patients with renal
impairment’ |
| Date sent |
Product |
Reason |
| 28 November 2023 |
Epilim (PDF, 2
pages, 179KB) |
Potential risk to children of fathers treated with valproate -
Updated information regarding risk of neurodevelopmental
disorders including autism spectrum disorders after paternal
exposure to valproate in comparison to lamotrigine/levetiracetam |
| 10 August 2023 |
Estradiol (PDF,
3 pages, 506KB) |
Estradiol Transdermal Patches (Mylan) – Alternative Registered
Carton |
| 4 July 2023 |
Estradiol (PDF,
3 pages, 180KB) |
Estradiol Transdermal Patches (Mylan) previously supplied under
Section 29 |
| 6 June 2023 |
Fentanyl Sandoz
(PDF, 4 pages, 260KB) |
Product Labelling and Data Sheet updates – Fentanyl Sandoz
Transdermal patch |
| 30 May 2023 |
Epilim (PDF, 2
pages, 157KB) |
Sodium valproate (Epilim) use in people who can father
children: important new safety information |
| 6 April 2023 |
Topamax (PDF, 4
pages, 232KB) |
Topiramate use in
pregnancy: further restrictions
for safety |
| 24 February 2023 |
Lageviro
(PDF, 2 pages, 223KB) |
Lagevrio® molnupiravir 200 mg Capsules Extension to Shelf Life
of Stock in Market |
| 24 January 2023 |
Paxlovid (PDF,
3 pages, 193KB) |
Shelf life extension of Paxlovid® (nirmatrelvir 150 mg/ritonavir
100 mg), film coated tablets, TT50-10969 |
| 6 February 2023 |
Dexmedetomidine (PDF, 3 pages, 835KB) |
Increased risk of mortality in intensive care unit (ICU)
patients ≤63.7 years |
| Date sent |
Product |
Reason |
| 7 November 2022 |
Setrona (PDF,
2 pages, 415KB) |
Supply of Australian-labelled Setrona 100 mg tablets in New
Zealand |
| 3 November 2022 |
Imbruvica (PDF,
3 pages, 333KB) |
Data Sheet Updates to Dose Modifications for Adverse Reactions
and to Warnings and Precautions |
| 20 June 2022 |
Comirnaty (PDF,
2 pages, 813 KB) |
Presentations available in New Zealand |
| 9 June 2022 |
Coversyl
(PDF, 3 pages, 260 KB) |
Supply of Canadian-labelled Coversyl 2 mg, 4 mg and 8 mg perindopril
erbumine tablets in New Zealand |
| 10 May 2022 |
Motetis (tetrabenazine),
(PDF, 169 KB, 1 page) |
Change in appearance of Motetis 25 mg tablets |
| 14 April 2022 |
Lagevrio (molnupiravir),
(PDF 412 KB, 4 pages) |
Important safety information regarding the usage of Lagevrio |
| 5 April 2022 |
PAXLOVID
(nirmatrelvir 150 mg/ritonavir 100 mg), film coated tablets
(PDF, 292 KB, 5 pages) |
Supply of PAXLOVID (nirmatrelvir 150 mg/ritonavir 100 mg),
film coated tablets |
| 29 March 2022 |
ClopineCENTRAL™
(PDF, 168 KB, 2 pages) |
New improvements occurring on the ClopineCENTRAL™ website
effective 28th of March 2022 |
| 24 February 2022 |
NUVAXOVID
(COVID-19 Vaccine with Matrix-M Adjuvant) (PDF, 222 KB, 1 page) |
Supply of NUVAXOVID COVID-19 Vaccine in New Zealand |
| 31 January 2022 |
Ronapreve
(casirivimab and imdevimab) (PDF, 217 KB, 3 pages) |
Ronapreve solution for injection or infusion 120 mg/mL;
reduced neutralisation activity of the antibody combination
against the full-length S protein of the Omicron variant of
COVID-19 |
| Date sent |
Product |
Reason |
| 24 December 2021 |
Ronapreve
(casirivimab and imdevimab) (PDF, 362 KB, 3 pages) |
Important information about Ronapreve supplied in New
Zealand. |
| 22 December 2021 |
Comirnaty (COVID-19 mRNA vaccine) (Pfizer-BioNTech) |
Supply of new formulation of Comirnaty (COVID-19 Vaccine) in
New Zealand |
| 6 December 2021 |
Cuprior (trientine)
(PDF, 265 KB, 2 pages) |
Labelling exemption - Cuprior 150mg film-coated tablet |
| 3 December 2021 |
Alecensa(alectinib)
(PDF, 243 KB, 2 pages) |
Warnings and precautions and specific dose modification
guidance for management of haemolytic anaemia |
| 22 November 2021 |
AstraZeneca and Janssen COVID-19 vaccines
(PDF, 291 KB, 3 pages) |
Distinguishing between Thrombosis and Thrombosis with
Thrombocytopenia (TTS) following COVID-19 vaccinations |
| 18 November 2021 |
Tenecteplase (PDF,
2 pages, 373 KB) |
Update on tenecteplase supply shortage |
| 17 November 2021 |
COVID-19 Vaccine AstraZeneca (PDF, 3 pages, 215 KB) |
Supply of COVID-19 Vaccine AstraZeneca in
New Zealand
|
| 21 October 2021 |
Actemra (PDF,
4 pages, 753 KB) |
Supply of Actemra (tocilizumab) 162 mg/0.9 mL solution for
subcutaneous |
| 11 October 2021 |
Actemra (PDF,
4 pages, 753 KB) |
Supply of Actemra (tocilizumab) for hospital use |
| 6 September 2021 |
Actemra (PDF,
2 pages, 215 KB) |
Notification of temporary supply shortage for Actemra
(tocilizumab) |
| 12 July 2021 |
Comirnaty
(COVID-19 mRNA vaccine) (Pfizer-BioNTech) (PDF, 13 pages, 620
KB) |
Supply of Comirnaty COVID-19 Vaccine in New Zealand |
| 17 May 2021 |
Novatretin (PDF,
2 pages, 598 KB) |
Increase in period during which effective contraception must be
used has increased from two to three years and important
information about blood donations |
| 17 May 2021 |
Engerix-B (PDF,
3
pages, 209 KB) |
Supply of Engerix-B paediatric vaccine 10 mcg/0.5ml (Hepatitis B
vaccine) – Australian pack |
| 13 April 2021 |
Influenza
Vaccines (PDF, 2
pages, 259 KB) |
Important information: Influenza vaccines for SH2021 |
| 28 March 2021 |
Macrobid (PDF, 2
pages, 242 KB) |
Macrobid modified-release capsule release characteristics and
in-use shelf life |
| 23 March 2021 |
Priorix (PDF, 2
pages, 319 KB) |
Priorix vaccine will be supplied as a single-dose in a Singapore
pack. |
| 15 March 2021 |
Veracloz
(PDF, 1 page, 177 KB) |
Clopine 50 mg/mL oral suspension brand is being replaced by
Versacloz 50 mg/mL oral suspension |
| 14 February 2021 |
Comirnaty
(COVID-19 mRNA vaccine) (Pfizer-BioNTech) (PDF, 9 pages, 2.07
MB) |
Supply of Comirnaty COVID-19 Vaccine in New Zealand |
| 28 January 2021 |
Tenecteplase (PDF,
2 pages, 316 KB) |
Tenecteplase supply shortage |
| 13 January 2021 |
Clopine (PDF,
1 page, 94 KB) |
Clopine Central Database: Updated blood monitoring
threshold levels and its impact on colour coding has been
delayed |
| Date sent |
Product |
Reason |
| 14 December 2020 |
Metalyse
(PDF, 2 pages, 128 KB) |
Temporary Medicine Shortage of Metalyse (tenecteplase) |
| 14 December 2020 |
Clopine
(PDF, 1 page, 108 KB) |
Clopine Central Database: Updated blood monitoring
threshold levels and its impact on colour coding has been
delayed |
| 16 November 2020 |
Minirin (PDF, 2 pages, 270 KB) |
Letter to Pharmacist – Notification of shortage of Minirin
(desmopressin acetate) nasal drops |
| 16 November 2020 |
Minirin (PDF, 2 pages, 268 KB) |
Letter to Prescriber – Notification of shortage of Minirin
(desmopressin acetate) nasal drops |
| 11 November 2020 |
Lyrica (PDF, 2 pages, 149 KB) |
Supply of Australian-labelled Lyrica (pregabalin) 150 mg capsules in New Zealand |
| 9 November 2020 |
Tecentriq
(PDF, 2 pages, 215 KB) |
Tecentriq® (atezolizumab), Identified Risk of Severe Cutaneous
Adverse Reactions (SCARs)
Correction note
(PDF, 1 page, 147 KB) |
| 5 November 2020 |
Engerix-B (Paediatric) (PDF, 3 pages, 244 KB) |
Supply of Engerix-B paediatric vaccine 10 mcg/0.5ml
(Hepatitis B Vaccine) – Australian pack |
| 1 October 2020 |
Norimin/Brevinor-1 28 Day (PDF, 1 page, 58 KB) |
Notification of temporary disruption to product supply |
| 4 September 2020 |
Setrona (PDF, 2 pages,
757 KB) |
Supply of Australian-labelled Setrona 50 mg and 100 mg
tablets in New Zealand
|
| 18 August 2020 |
Brevinor
28 Day (Australian Stock) (PDF, 1 page, 158 KB) |
Temporary alternative product supply to cover Norimin stock
shortage |
| 16 June 2020 |
Tramal (PDF, 2 pages, 597 KB) |
Tramal (tramadol) data sheet safety update to precautions and
contraindications |
| 27 May 2020 |
Microlut (PDF, 2
pages, 380 KB) |
Reason: Supply of Australian labelled Microlut to New
Zealand
|
| 28 April 2020 |
Plaquenil (PDF, 4
pages, 358 KB) |
Use of Hydroxychloroquine [Plaquenil®] in the context of
COVID 19 – Risk of QT prolongation and drug/drug interactions
|
| 1 April 2020 |
Typhim Vi (PDF,
2 pages, 680 KB) |
Supply of Typhim Vi under labelling exemption
|
| 1 April 2020 |
Reopro (PDF, 2
pages, 78 KB) |
Discontinuation of Reopro (abciximab) 10mg/5mL solution for
injection vials as of 30 June 2020 - information for
healthcare professionals
|
| 12 February 2020 |
Nozinan (Swiss
Stock) (PDF 299 KB, 2 pages) |
Change in supply of Nozinan (levomepromazine) tablets to
product sourced from Switzerland - information for
healthcare professionals
|
| 7 February 2020 |
Nozinan
(Swiss Stock) (PDF 233 KB, 1 page) |
Change in supply of Nozinan (levomepromazine) tablets to product
sourced from Switzerland - information for patients |
| 21 January 2020 |
Gardasil 9
(PDF 43 KB, 1 page) |
Issue with 'tear-off' labels for Gardasil 9 vaccine
|
| 14 January 2020 |
Accuretic
(PDF 490 KB, 2 pages) |
Supply of Accuretic 10mg/12.5mg tablets in alternative
(Canadian) artwork to New Zealand |
| Date sent |
Product |
Reason |
| 18 December 2019 |
Xiaflex
(PDF 128 KB, 1 page) |
Xiaflex (collagenase clostridium histolyticum) product approval
lapse on 31 March 2020
|
| 17 December 2019 |
Tivicay and dolutegravir containing regimens
(PDF 134 KB, 2 pages) |
Updated information on neural tube defects reported in Tsepamo
Study, Botswana
|
| 27 November 2019 |
Kadycla
(PDF 128 KB, 2 pages)
|
Important Kadcyla® (trastuzumab emtansine) Safety
Communication: Potential Risk for Medication Error Between
Kadcyla® and Herceptin® (trastuzumab)
|
| 25 November 2019 |
Esbriet (pirfenidone)
(PDF 334 KB, 3 pages) |
Important Safety Update on Esbriet (pirfenidone) and
Drug-Induced Liver Injury (DILI)
|
| 25 September 2019 |
MMR II Vaccine
(PDF 501 KB, 4 pages) |
Additional supply of MMR II measles, mumps and rubella vaccine:
differences in labelling and package inserts |
| 9 August 2019 |
Femme-Tab
(PDF 174 KB, 1 page) |
In light of recent shortage of Combined Oral Contraceptive
products, Microgynon® (Bayer) and Levlen® (Bayer) in New
Zealand, Femme-Tab ED 20/100 (Ethinyloestradiol 20 mcg +
Levonorgestrel 100 mcg) and Femme-Tab ED 30/150
(Ethinyloestradiol 30 mcg + Levonorgestrel 150 mcg) have
been available from 17 July 2019 |
| 17 July 2019 |
Ranbaxy-Cefaclor (PDF 222 KB , 1 page) |
Supply disruption for Cefaclor oral suspension and Acarbose
tablets: difference in reconstitution volume for Keflor granules
|
| 3 July 2019 |
FluQuadri
(PDF 109 KB, 2 pages) |
Additional supply of FluQuadri influenza vaccine: differences
in labelling and package inserts
|
| 13 June 2019 |
Tecentriq
(PDF 649 KB, 2 pages) |
Notification of Immune-related Myositis as new Important
Identified Risk for Tecentriq
|
| 11 June 2019 |
Xiaflex
(PDF 231 KB, 2 pages |
Xiaflex® (collagenase clostridium histolyticum) product discontinuation
from 28 June 2019 |
| 7 May 2019 |
Actemra
(PDF 361 KB, 3 pages) |
New important identified risk: Hepatoxicity |
| 26 March 2019 |
Darzalex (PDF
103 KB, 2 pages) |
New important identified risk: Hepatitis B Reactivation |
| 15 February 2019 |
Esmya (PDF
115 KB, 2 pages) |
Important safety update following reports of serious liver injury |
| Date sent |
Product |
Reason |
| 21 December 2018 |
Epilim
(PDF 68 KB, 1 page) |
Updated educational materials for use in women of child-bearing
potential |
| 5 December 2018 |
Tecentriq (PDF 501, 2 pages) |
Revision of indication for treatment of locally advanced or
metastatic urothelial carcinoma |
| 5 December 2018 |
Tecentriq
(PDF 645 KB, 2 pages) |
New important identified risk: Nephritis |
| 27 September |
Coaguchek
(PDF 559 KB, 8 pages) |
Roche reconfirms their recommendation that Coaguchek INR results
above 4.5, from lots specified in the attached notification, are
confirmed with a laboratory method. |
| 25 September 2018 |
Volulyte
and Voluven (PDF 821 KB, 2 pages) |
Safety information update |
| 20 August 2018 |
Dilantin (PDF
209 KB, 2 Pages) |
Clarification regarding Dilantin Dear Healthcare Professional
Letter dated
19 July
2018 |
| 13 August 2018 |
Bicillin
(PDF 1,135 KB, 4 Pages) |
Changes to expression of product strength |
| 6 August 2018 |
Tivicay
(PDF 87 KB, 3 Pages) |
Tivicay (dolutegravir): neural tube defects reported in Tsepamo
Study, Botswana |
| 19 July 2018 |
Dilantin (PDF 91 KB, 2 Pages) |
Dissolution profile of Dilantin® 30 mg and 100 mg capsules (New
Formulation) |
| 3 July 2018 |
Neulactil (PDF
78 KB, 2 pages) |
Provisional Consent of Neulactil periciazine 2.5mg and 10mg
tablets (Hong Kong stock) to cover temporary stock shortage |
| Date sent |
Product |
Reason |
| 5 December 2017 |
Ofev (PDF 1052 KB,
2 pages) |
Information on severe liver injury in patients with idiopathic
pulmonary fibrosis |
| 3 August 2017 |
Tecentriq
(PDF 70 KB, 2 pages) |
Severe cases of myocarditis |
| 27 March 2017 |
Zelboraf (PDF
98KB, 2 pages) |
Risk of Dupuytren's Contracture and Plantar Fascial Fibromatosis |
| 14 December 2016 |
Erivedge
(PDF 110 KB, 2 pages) |
Extension of Pregnancy Prevention Duration for Women of Childbearing
Potential and Interval before Blood Donation and Lactation |
| 15 August 2016 |
Noxafil (PDF
212 KB, 2 pages) |
Posaconazole tablets and oral suspension are not interchangeable |
| 2 June 2016 |
Erivedge (PDF
111 KB, 2 pages) |
Risk of premature epiphyseal fusion |
| 24 May 2016 |
Invokana (PDF
71 KB, 2 pages) |
Advice on the risk of lower limb amputations primarily of the
toe during treatment with canagliflozin |
| 8 December 2015 |
Cellcept
(PDF 100 KB, 3 pages) |
New restrictions on use due to teratogenic risk |
| 1 December 2015 |
Tarceva (PDF
91 KB, 2 pages) |
Indication restricted to EGFR-activating mutations only |
| 9 July 2015 |
Forxiga (PDF
28 KB, 2 pages) |
Risk of ketoacidosis |
| 29 April 2015 |
Motilium (PDF
344 KB, 1 page) |
New recommendations to minimise cardiac risks |
