Apo-Clomipramine brand 10 mg tablets in short supply
The supplier, Apotex, advises that there is a short supply of clomipramine 10 mg tablets (Apo-Clomipramine brand). The shortage of Apo-Clomipramine 10 mg tablet is likely to last from mid-August 2020 until November 2020.
There is no shortage of clomipramine 25 mg tablets.
The Apo-Clomipramine brand is the only clomipramine 10 mg and 25 mg tablet currently approved by Medsafe.
Anafranil 10 mg is the alternative (section 29)
To ensure patients still have access to clomipramine 10 mg tablets, we’re listing Anafranil as an alternative brand.
Anafranil is an unapproved medicine in New Zealand. As such, it must be supplied under section 29 of the Medicines Act 1981.
What you need to know about Anafranil:
- Anafranil has the same active ingredient at the same strength as Apo-Clomipramine
- Anafranil has been approved for use in Germany
- Anafranil has slightly different packaging and presentation from Apo-Clomipramine
- An English translation of the product leaflet for Anafranil will be provided
Anafranil will be:
- listed from 1 August 2020
- available for distribution in mid-August 2020 (once the Apo-Clomipramine stock is exhausted).
What section 29 means
Section 29 allows for medicines that are not Medsafe approved to be supplied to people. The medicine must be prescribed by someone registered with the Medical Council of New Zealand – that is, doctors.
We know supplying a medicine under section 29 is not ideal. In this case, however, the alternative would be for patients to have no 10 mg formulation of clomipramine at all.
We appreciate that this limits the ability of non-medical prescribers to prescribe this medicine. We apologise for any inconvenience this causes.
What to do if you take clomipramine
If you are taking Apo-Clomipramine 10 mg, you will need to talk to your prescriber about the best solution for you.
If it's decided that the Anafranil 10 mg brand of clomipramine is the best option for you, you will need a new prescription from a doctor.
Anafranil is not an approved medicine in New Zealand. This means there are extra requirements your doctor must meet when prescribing it.
If you are taking Apo-Clomipramine 25 mg, you do not need to do anything differently.
What prescribers need to know
Anafranil is an unapproved medicine in New Zealand. As such, it needs to be supplied in line with section 29 of the Medicines Act 1981. Prescribers need to be familiar with their obligations under section 29.
Only medical practitioners registered with the Medical Council of New Zealand can supply section 29 medicines.
What pharmacists need to know
The Anafranil brand of clomipramine 10 mg tablets will be listed in Section B of the Pharmaceutical Schedule from 1 August 2020.
It will be listed on the Schedule to be supplied in line with section 29 of the Medicines Act.
Wastage rules will apply.
- Apo-Clomipramine tab 10 mg, Pharmacode 2289822
- Anafranil tab 10 mg, Pharmacode 2594927
