FOI release

FOI- Revolade 25 mg, 50 mg and 75 mg film-coated tablets

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2024/00632

Received 16 October 2024

Published 20 November 2024

Request

hereby submits the following Freedom of Information request with regards to the Marketing Authorisations for Revolade 25 mg, 50 mg and 75 mg film-coated tablets (PLGB 00101/1126-1128-1129) held by Novartis Pharmaceuticals UK Limited. The details of the request are as follows: * The Environmental Risk Assessment document named Revolade(r) (eltrombopag olamine) 25 and 50 mg film coated tablets Environmental Risk Assessment and associated study/chemical testing reports that are currently registered in module 1.6 for the following Product Licences (PLGB 00101/1126, PLGB 00101/1128, PLGB 00101/1129) In accordance with the Heads of Medicines Agencies/European Medicines Agency (HMA/EMA) guidance on transparency, the environmental risk assessment information within module 1.6 requested is considered releasable, as outlined in pages 5 and 25 of the HMA/EMA guidance.

Response

see attached

Documents

• Environmental Risk Assessment Non-GMO (ITP).pdf (9.7 MB)
• Environmental Risk Assessment Non-GMO (SAA).pdf (8.8 MB)
• FOI2024-00632 redacted for publication.pdf (110.6 KB)

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