Dynastat - supply shortage
Ongoing
parecoxib
ShortageHuman
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There is a shortage of Dynastat in some Members States of the European Economic Area (EEA).
Dynastat is a medicine used in adults for the short-term relief of pain after an operation. It is given by injection into a vein or muscle.
For further information on the use of the medicine, please refer to the medicine’s overview page.
The shortage is due to a reduction in the production capacity of Dynastat, following a temporary shutdown of one of the company’s production lines. The company is prioritising supply to markets where shortages are considered critical, with no country in the EEA currently experiencing critical shortages. Although the affected line has now resumed production, the company will need time to meet the current demand for Dynastat in the EEA.
The shortage currently affects seven EEA countries where the product is marketed: Cyprus, Greece, Malta, Bulgaria, France, Germany and Norway. The shortage in the Netherlands and Iceland is now resolved.
The shortage is expected to last until:
Other EEA countries are at risk of shortage and the above information may change. For up-to-date information about the status of a medicine shortage in a particular Member State, consult the national shortage register or contact the national competent authority.
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and EMA’s shortages working party (Medicines Shortages Single Point of Contact – SPOC - working party) are closely monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage.
In addition, the marketing authorisation holder is working to expedite and coordinate the distribution of Dynastat in a way that minimises the impact of shortages and is exploring options to increase its production.