In nasal spray recall DEXA-RHINASPRAY-N N.SP.SU.MD (0.028 + 0.1717) MG / ACTUATION the AEO proceeded.
As stated in the announcement, the recall is made “after informing the Marketing Authorization Holder about results outside the specifications found in the stability study, in terms of the content of one of the two active ingredients and its degradation products, in 2 batches of product,” the organization said in a statement.
The company Opella Healthcare Greece that has the marketing license must contact the recipients of the specific batches immediately and withdraw them from the market.
See the table of EOF:
The entire announcement of EOF:
SUBJECT: “Recall of batches of the medicinal product DEXA-RHINASPRAY-N N.SP.SU.MD (0.028 + 0.1717) MG / ACTUATION”
Marketing Authorization Holder: Opella Healthcare Greece
DECISION
Taking into consideration:
1. Article 6, par. II, paragraph 8 of Law 1316/83 (Government Gazette 3 AD) “Establishment, organization and responsibilities of EOF”, as replaced by article 25 of Law 3730 / 2008 (Government Gazette 262 BW)
2. Article 169, par. 2 of no. ΔΥΓ3α / Γ.Π.32221 / 29.4.2013 ΚΥΑ (ΦΕΚ 1049 Β ‘)
3. The no. 30941 / 24-03-2022 correspondence of Opella Healthcare Greece
4. The no. 30941 / 12-04-2022 correspondence EOF
5. The no. 40894 / 18-04-2022 correspondence of Opella Healthcare Greece
WE DECIDE
The recall of the above batches of the medicinal product DEXA-RHINASPRAY-N N.SP.SU.MD (0.028 + 0.1717) MG / ACTUATION, after informing the Marketing Authorization Holder for results outside the specifications found in the stability study, in terms of the content of one of the two active ingredients and its degradation products, in 2 batches of product.
This Decision is issued as a precaution for the protection of Public Health.
Opella Healthcare Greece, as the Marketing Authorization Holder, must contact the recipients of the specific batches immediately and withdraw them from the market within a reasonable period of time.
The relevant documents are kept for a period of at least five (5) years and are brought to the attention of the AEO, if requested.
THE PRESIDENT OF EOF
DIMITRIOS FILIPPOU
Follow Skai.gr on Google News
and be the first to know all the news
I have worked in the news industry for over 10 years. I have a vast amount of experience in covering health news. I am also an author at News Bulletin 247. I am highly experienced and knowledgeable in this field. I am a hard worker and always deliver quality work. I am a reliable source of information and always provide accurate information.
