Information to the Marketing Authorisation Holder – Hydroxyzine hydrochloride/Atarax


Referral Art. 31, EMEA/H/A-31/1400 regarding Hydroxyzine hydrochloride/Atarax is finished.

Approved Icelandic texts

Approved English texts

The applicant shall apply for this change either as IA(IN) C.I.1.a. (using the proposed Icelandic text unchanged) or IB.C.I.1.a. (if the proposed Icelandic text must be changed to adapt to the relevant text).

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