Renewal of registration for the drug Nurofen for children

In mid-February, an order was published on the website of the State Register of Medicines (GRLS) to resume the use of the drug Nurofen for children. The use of the drug was suspended on August 7, 2019.

We are talking about the drug ibuprofen in the dosage form of rectal suppositories, 60 mg. The marketing authorization holder is Reckitt Benckiser Group and the manufacturer is Famar A.V.E. It is a contract manufacturer with factories in Canada, France, Spain, Italy, the Netherlands and Greece, where the company has two sites. The drug Nurofen® for children is produced at one of the Greek sites.

The basis for suspending the use of the drug was a letter from the Ministry of Industry and Trade dated August 2, 2019, which “provided information about the drug manufacturer’s non-compliance with the requirements of the rules of good manufacturing practice and (or) violation of licensing requirements.”

Following the letters from the Ministry of Industry and Trade and the Ministry of Health of the Russian Federation, in December 2019, a letter from Roszdravnadzor was published on the withdrawal of batches of the drug from circulation (21 batches in total), as well as on the termination of declarations of conformity for these batches.

The Reckitt Benckiser Group also owns other ibuprofen brand names - 12 in total, most of which are manufactured in the UK by the Reckitt Benckiser Group. Only suppositories are produced at the production site in Greece.

In addition to ibuprofen, the Reckitt Benckiser Group portfolio also includes such popular drugs as Strepsils® and Gaviscon®.

The Reckitt Benckiser Group also owns such popular brands as Finish, Veet, Air Wick, Calgon, Tiret, etc.