In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
Having reviewed the available data from the EudraVigilance database, literature sources and national reviews, including the cumulative review provided by the registration certificate holder (RCH) of the original medicinal product (JANSSEN-CILAG) containing galantamine, the PRAC concluded that RCHs must amend the instructions for medical use as described below, taking into account the wording already present (new text underlined).
- “Adverse reactions” section
SOC “Psychiatric disorders”
Nightmares with “not known” frequency.
List of medicinal products containing galantamine and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 31.03.2026). (10 KB) (Downloaded: 10.04.2026 09:33:38)
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINKS:
