Nolotil Injection Leaves the Portuguese Market on 1 February 2027 for Manufacturing Reasons, and Infarmed Tells Hospitals to Adapt Pain Protocols Now
Boehringer Ingelheim will stop selling Nolotil 2,000 mg/5 ml injection in Portugal from 1 February 2027, citing manufacturing reasons. Infarmed says a sodium metamizole injection stays available and asks hospitals to adapt their protocols in good time.
Nolotil injection, the hospital form of the painkiller metamizole, will no longer be sold in Portugal from 1 February 2027. Infarmed (the National Authority of Medicines and Health Products) announced the change on 16 October in an information circular, saying the marketing authorisation holder, Boehringer Ingelheim Portugal, is stopping sales "for manufacturing reasons".
The circular names a single product: Nolotil, magnesium metamizole (metamizol magnésico), 2,000 mg in 5 ml, solution for injection, registration number 8512202. It does not mention any other form of the medicine.
What the drug is used for
According to Infarmed, medicines containing magnesium metamizole are indicated for severe acute pain, including spasmodic pain and cancer pain, and for high fever that does not respond to other fever treatments. Metamizole is also known as dipyrone.
The regulator says the injection is used in acute situations, for short periods and mostly in hospitals. Even so, it wants the impact kept to a minimum and recommends that existing treatment protocols be adapted in good time. In practice that message is aimed at hospitals and the clinicians who write their pain and fever protocols, with three and a half months to go before the product leaves the market.
What stays on the market
No other medicine containing magnesium metamizole as an injectable solution is authorised and marketed in Portugal, Infarmed says. A sodium metamizole injection, Metamizol Basi at 500 mg per ml, will remain available, alongside other medicines with overlapping therapeutic indications. The circular does not name those other medicines.
The announcement comes as Portugal is already managing tight supply of a number of medicines. Infarmed barred exports of 52 scarce medicines earlier this month, and generic makers have argued that prices must rise in 2027 to keep products on the shelves. Infarmed gives no reason beyond manufacturing for the Nolotil decision.
The wider European picture
Infarmed does not link the withdrawal to safety. Metamizole has, however, been reviewed at European level. In 2024, at the request of Finland's medicines agency, the European Medicines Agency's safety committee (PRAC) examined the risk of agranulocytosis, a sudden and sharp fall in a type of white blood cell that can lead to serious or fatal infections. The committee concluded that the benefits of metamizole continue to outweigh the risks, but tightened the warnings for every product. The European Commission made those changes binding across the EU on 22 November 2024.
Under those rules, patients must be told to stop the medicine and seek medical help at once if they develop fever, chills, a sore throat or painful sores in the mouth, nose, throat or genital area, during treatment or shortly after it. The EMA lists metamizole as authorised in 18 EU countries, Portugal and Spain among them. In Finland, the only authorised product was withdrawn.
Questions about a specific treatment should go to the prescribing doctor or a pharmacist. Infarmed's medicines line, the Linha do Medicamento, answers on 800 222 444, and its information centre (CIMI) can be reached at [email protected].
