HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


EU Regulatory News Round Up: NSAIDs During Pregnancy, Estragole Excipients, ePIs

Executive Summary

CMDh receives applications to change how NSAIDs are recommended for use during pregnancy; HMPC warns against use of estragole-containing excipients in herbals; EMA adopts new EU common standard for electronic product information on medicines marketed within the region.

You may also be interested in...

AESGP Annual Meeting, Day 2 (Part 2): Can Regulation Be A Catalyst For Innovation?

Regulation should be seen as a spur to creativity rather than a burden, suggest panellists during the second session of the AESGP's 58th Annual Meeting in Madrid, Spain. Sanofi Consumer Healthcare boss Julie van Ongevalle also makes the case for electronic patient information leaflets as a way to learn from the pandemic, which she describes as the greatest constraint the world has experienced in recent history.

Self-Care Key To EU Pharmaceutical Strategy, Says Rapporteur

Only with help of the non-prescription medicines sector will the aims of the new European Union pharmaceutical strategy be achieved, argues MEP and rapporteur Dolors Montserrat at the AESGP Annual Meeting. 

Approvals For Stronger NSAIDs Label Warning About Risks During Late Pregnancy Begin In US

FDA since late October has sent approvals to firms which had submitted proposals for updates under the “If pregnant or breast-feeding” warning on their OTC NDAID DFls. First approval, dated 21 October, went to Bionpharma for its 200-mg ibuprofen tablets it provides for private label and store brand customers.

Related Content


Latest News



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts