#Ask and it is given reviews registration

We are receiving a large volume of emails enquiring about progress. Submissions which do not pass the basic automated check will be automatically rejected.ДЇor records that are within 30 days of submission, registrations from the UK will continue to be prioritised because PROSPERO is funded by the National Institute for Health Research (NIHR). Records will be published exactly as submitted therefore extra care should be taken to ensure that submitted information is accurate. The PROSPERO team will not check these submissions this will be stated clearly on the published record.

#Ask and it is given reviews registration

The Committee will issue a scientific opinion within the shortest possible timeframe for EU Member States to consider when making decisions on the use of this medicine at national level before a formal marketing authorisation is issued.To allow the PROSPERO team to focus on COVID-19 and to avoid further delay, during the pandemic all submissions that have been waiting for registration for more than 30 days and which pass a basic automated check will be published automatically. The review is being carried out by EMAвЂ™s Committee for Medicinal Products for Human Use ( CHMP), which is responsible for questions concerning medicines for human use. More about the procedureД®MAвЂ™s Executive Director requested the review under Article 5(3) of Regulation 726/2004 following preliminary discussions with EMAвЂ™s COVID-19 pandemic task force (COVID-ETF), which brings together experts from across the European medicines regulatory network. The medicine is expected to reduce the need for hospitalisation in patients with COVID-19.

Paxlovid also contains a low dose of ritonavir (a protease inhibitor), which slows the breakdown of PF-07321332, enabling it to remain longer in the body at levels that affect the virus.

The active substance PF-07321332 blocks the activity of an enzyme needed by the virus to multiply. Paxlovid is an oral antiviral medicine that reduces the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body. EMA will communicate on the outcome of this review once it concludes. While a more comprehensive rolling review is anticipated to start ahead of a possible application for a marketing authorisation, this current review will provide EU-wide recommendations in the shortest possible timeframe so they can be used by national authorities who wish to take evidence-based decisions on the early use of the medicine.ДЄuthorities in the EU remain committed to expediting the evaluation of much needed COVID-19 treatments and vaccines, while ensuring these meet the EUвЂ™s high standards of safety and efficacy. The CHMP will also review data on the medicineвЂ™s quality and safety. The preliminary results indicate that Paxlovid reduced the risk of hospitalisation or death compared with placebo when treatment was given within 3 or 5 days of the start of symptoms. EMA is starting this review to support national authorities who may decide on its early use for COVID-19, for example in emergency use settings, prior to marketing authorisation.Д®MAвЂ™s human medicines committee ( CHMP) will look at data from a study comparing the effect of Paxlovid with that of a dummy treatment (placebo) in non-hospitalised patients with mild to moderate COVID-19 who were at high risk of progressing to severe disease. EMA is reviewing currently available data on the use of Paxlovid (PF-07321332/ritonavir), an oral treatment for COVID-19 developed by Pfizer.