Suspension CEP MAC CHEM PRODUCTS (India) - Suspension CEP MAC CHEM PRODUCTS (India)
Suspension CEP MAC CHEM PRODUCTS (India)
The Marketing Authorization Holders (MAHs) of medicinal products for human use intended for Italian market, authorised through National or Mutual recognition/Decentralised procedure, and/or Italian manufacturers of medicinal products to be exported, are requested to verify, as a matter of urgency, if in their medicinal products containing the mentioned active substances/ intermediates, these are covered by the respective CEPs.
- 2012-025 (suxamethonium chloride)
- 2012-251 (cytarabine)
- 2012-350 (letrozole)
- 2012-147 (carboplatin)
- 2012-066 (dacarbazine)
- 2017-164 (gefitinib)
- 2017-246 (ropivacaine hydrochloride monohydrate)
- 2015-141 (pemetrexed disodium heptahydrate)
- 2019-024 (neostigmine metilsulfate)
- 2018-063 (irinotecan hydrochloride trihydrate)
- 2019-329 (bicalutamide)
- 2020-012 (cisplatin)
- 2020-074 (etoposide)
ONLY in case of positive feed-back, companies should send immediate notification to the AIFA, Medicinal Product Authorization Department (AAM) specifying if alternative manufacturers are available or if the active substance/intermediate manufacturers covered by the a.m. CEPs are the only ones authorized.
It is required to specify the European procedure code for medicinal products authorized by Mutual Recognition/Decentralised procedure.
The communications should be received by 26/11/2022 to the mailbox: infocepgmp@aifa.gov.it
Published on: 16 November 2022