What are acetaminophen pills

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Date 03/13/2017
Active ingredient Paracetamol - modified release

03/13/2017 - Implementing decision of the European Commission

On February 19, 2017, the European Commission issued implementing decision C (2018) 1151 on the risk assessment procedure according to Article 31 of Directive 2001/83 / EC on paracetamol-containing medicinal products with modified or extended release. The commission has decided that the approvals of paracetamol-containing drugs with modified release of active ingredients should be suspended.
With these drugs, the active ingredient paracetamol is released over a longer period of time than with conventional quick-release products. The position of the Coordination Group for Mutual Recognition and Decentralized Procedures (CMDh) becomes legally binding and the risk assessment process is concluded.

The technical reasons for this can be found in the annexes to the above-mentioned implementing decision, which can be found on the website of the European Commission.

Paracetamol - Implementing Decision

Drugs containing paracetamol with modified release are approved or on the market in various EU member states, but not in Germany. Rapid-releasing paracetamol-containing products are not affected by this rating.

December 15, 2017 - Decision of the CMDh

The Coordination Group for Mutual Recognition and Decentralized Procedures (CMDh) confirms the PRAC recommendation that the approval of paracetamol-containing drugs with modified or extended release (the active ingredient paracetamol is released over a longer period of time than with conventional rapid-release products) should be suspended. Since the CMDh is not a unanimous decision, the EMA will send it to the EU Commission for a binding implementation decision to be issued.

Drugs containing paracetamol with modified release are approved or on the market in various EU member states, but not in Germany.

01.12.2017 - PRAC recommendations after renewed evaluation

The BfArM informs about the recommendations of the PRAC after a new evaluation of paracetamol-containing drugs with modified release.
The PRAC has confirmed its recommendation that the approval of paracetamol-containing drugs with modified or extended release (the active ingredient paracetamol should be released slowly over a longer period of time than with conventional rapid-release products) should be suspended.
Rapid-release paracetamol-containing products are not affected by this assessment and are therefore still available.
Since all medicinal products affected by this procedure are nationally approved, the PRAC recommendation is sent to the Coordination Group for Procedures of Mutual Recognition and Decentralized Procedures (CMDh), which then issues an opinion.

09/29/2017 - Request for a new evaluation

Two marketing authorization holders have requested a reassessment of the PRAC recommendation.

01.09.2017 - Recommendations of the PRAC

The BfArM informs about the recommendations of the PRAC within the framework of a European risk assessment procedure according to Art. 31 of the Directive 2001/83 / EG for paracetamol-containing drugs with modified release.
After an assessment by the EMA's drug safety experts, they recommended that the marketing of paracetamol-containing drugs with modified or extended release (the active ingredient paracetamol should be released slowly over a longer period of time than with conventional rapid-release products) should be suspended.

07/18/2016 - start of the procedure

The European Medicines Agency (EMA) will evaluate the risk-benefit ratio of paracetamol tablets with modified release that are on the market in various EU member states but not in Germany. These paracetamol tablets release the active ingredient over a longer period of time and are different from the immediate-release tablets, which are not the subject of the risk assessment process.
The standard procedure for investigating and managing acetaminophen overdoses and poisoning is designed for immediate release products. Over the past few years there have been reports of overdoses associated with certain modified release paracetamol tablets, indicating that the standard procedure may no longer be adequate to adequately treat overdosage with these products.
The Pharmacovigilance Risk Assessment Committee (PRAC) will carry out the review at the request of the Swedish Medical Devices Agency (MPA). The PRAC will evaluate available guidance to assess the risk of overdose with modified and extended release paracetamol tablets with a view to taking additional measures. In the meantime, patients should discuss their medication concerns with their doctor or pharmacist.

More about the drug
Paracetamol is a medicine that has been used for many years to treat pain and fever in adults and children. Immediate release paracetamol tablets have been approved in all EU member states as part of national procedures. Longer-acting products - such as Alvedon 665 mg - that contain modified-release paracetamol are available in some EU countries. Some modified-release combination drugs that contain paracetamol along with other pain relievers will also be included in the procedure.

Details on the procedure can be found at the European Medicines Agency (EMA) under the following link:

Paracetamol-modified release