Shortage of Rivatril products continues – extensions to fixed-term special permits (updated 2.3.2023)

The shortage of the medicinal product Rivatril continues. This product has been granted a marketing authorisation. The marketing authorisation holder of the medicinal product has reported that the shortages of both 0.5 mg and 2 mg products will continue until 31 March 2023. The estimated end date displayed on Fimea’s website is subject to the marketing authorisation holder’s reports. For more information on shortages, contact the marketing authorisation holder.

Fimea has received numerous requests to resolve the dire shortage of Rivatril quickly. Fimea is the Finnish licensing and supervisory authority in the pharmaceutical sector. Fimea does not have the power or the ability to manufacture, acquire or import medicines, for instance. 

Due to shortages of Rivatril products, Fimea has granted extensions to the fixed-term special permits of the following medicinal products from 1 March 2023 to 30 April 2023. 

• Clonazepam Tablets, USP 0.5 mg 100 tablets (pharmaceutical wholesaler: Oriola Finland Oy, Tamro Oyj)
• Clonazepam Tablets, USP 2 mg 100 tablets (pharmaceutical wholesaler: Oriola Finland Oy, Tamro Oyj)
• Rivotril 0.5 mg 50 tablets (pharmaceutical wholesaler: Oriola Finland Oy)
• Rivotril 2 mg 100 tablets (pharmaceutical wholesaler: Oriola Finland Oy)

Due to shortages of Rivatril products, Fimea has also granted fixed-term special permits for the following medicinal products from 2 March 2023 to 30 April 2023.

• Clonazepam Auden Tablets 500 microg 100 tablets (pharmaceutical wholesaler: Oriola Finland Oy, Tamro Oyj)
• Clonazepam Auden Tablets 2 mg 100 tablets (pharmaceutical wholesaler: Oriola Finland Oy, Tamro Oyj)

Fixed-term special permits have been granted for longer than the current duration of the shortage to improve the availability of medicines to patients and facilitate any reintroduction of medicinal products with a marketing authorisation after the shortage has ended.  Fimea will continue to process all related permits within the limits of Fimea’s power without delay as needed. Permits will also be granted to all applications that meet the criteria if they are applied for to Fimea. 

Medicinal products without a Finnish marketing authorisation with a valid, fixed-term special permit may be released for consumption from pharmacies to patients with a prescription alone, i.e., there is no need to submit a separate special permit application to Fimea. Products with a fixed-term special permit may be prescribed with an electronic prescription. 

Generic prescription is not possible for medicinal products with special permits, meaning that each medicinal product requiring a special permit needs a separate prescription for each patient. If necessary, we recommend that you contact the attending physician to ensure substitute treatment if a shortage threatens to interrupt medication.

Fimea has received inquiries on the availability of medicinal products with special permits. Fimea does not have detailed information on the arrival of medicinal products with special permits to Finland, as there is no statutory obligation to provide information on the availability of products with special permits to Fimea, contrary to medicinal products with a marketing authorisation. The most up-to-date and detailed information on regional availability of medicines is available at the nearest pharmacy. If necessary, pharmacies may ask about future availability from pharmaceutical wholesalers that distribute medicines. 

Read more:

Substitutes for the shortage of the medicinal product Rivatril are also in short supply (in Finnish)

(Updated 2.3.2023 at 15:39)