GREY:ATBPF - Post by User
Post by
RunningofdBullson Jan 31, 2021 7:54am
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Post# 32430717
One step closer
One step closerFyi, excerpt below is from the recent EMA conference agenda held Jan 26-29, 2021, see page 41 and which can be found here: https://www.ema.europa.eu/en/human-regulatory/research-development/paediatric-medicines/paediatric-investigation-plans/class-waivers 6. Discussion on the applicability of class waivers
Disclosure of some information related to this section cannot be released at the present time as it is deemed to contain commercially confidential information.
6.1. Discussions on the applicability of class waiver for products 6.1.1. Paclitaxel - EMEA-12-2020 Athenex Inc.; First-generation taxoid medicinal products / Breast malignant neoplasms Action: For adoption
6.1.2. Otenaproxesul - EMEA-09-2020 Antibe Therapeutics; All classes of medicinal products for treatment of primary and secondary osteoarthrosis / Treatment of the signs and symptoms of osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers Action: For adoption Class waivers are for medicines that are not required to submit a paediatric investigation plan as part of a marketing authorisation application. I'm suspecting they got the waiver since last time I checked, children don't get OA!