Laboratorios Farmaceuticos Rovi S A : ROVI informs on the notification of particulate matter having been seen in certain drug product vials of the Moderna's COVID-19 vaccine distributed in Japan
August 26, 2021 at 12:21 pm EDT
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TO THE NATIONAL SECURITIES MARKET COMMISSION
Madrid, 26 August 2021
OTHER RELEVANT INFORMATION
Laboratorios Farmacéuticos ROVI, S.A. (ROVI), in compliance with the information duties set out in article 227 of the Revised Text of the Securities Market Act, as an entity participating in the manufacturing process of Moderna's vaccine against Covid- 19, and in relation to the notification of particulate matter having been seen in certain drug product vials of the vaccine distributed in Japan, informs that ROVI is currently conducting an investigation on this event, following the standard procedure for these cases.
The detection of this particulate matter refers to certain vials of one product lot distributed exclusively in Japan. ROVI, as well as Moderna and Takeda, the company distributing the referred vaccine in Japan, are working with health authorities in order to clarify and solve, if applicable, this incident
The origin of this manufacturing incident may be in one of ROVI's manufacturing lines. ROVI is working in order to provide with all the information and assistance that may be needed to progress with the investigation. As a precaution, this lot and two adjacent lots have been put on hold.
To date, no safety or efficacy issues have been identified in relation to the vaccine, as Moderna and Japanese authorities have reported.
ROVI will continue assisting proactively with the investigation.
Laboratorios Farmacéuticos ROVI SA published this content on 26 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 August 2021 16:20:02 UTC.
Laboratorios Farmaceuticos Rovi, S.A. specializes in the research, development, manufacturing and marketing of biological medications and specialty drugs. Net sales break down by family of products as follows:
- pharmaceutical products manufactured under contract (49%);
- prescription pharmaceuticals (45%): intended for preventing and treating venous thrombo-embolic disease, post-menopausal osteoporosis, muscle pain, tooth and mouth infections, angina, osteoarthritis, etc.;
- diagnostic products (6%): contrast products used in medical imaging with magnetic resonance, ultrasound, or X-rays. The group also offers hospital products and non-prescription pharmaceuticals.
Net sales break down by source of revenue between sales of products (50.6%), sales of services (49.3%) and sales of licenses (0.1%).
Net sales are distributed geographically as follows: Spain (33%), European Union (17.3%), OECD countries (45.9%) and other (3.8%).
Laboratorios Farmaceuticos Rovi S A : ROVI informs on the notification of particulate matter having been seen in certain drug product vials of the Moderna's COVID-19 vaccine distributed in Japan
LABORATORIOS FARMACEUTICOS ROVI, S.A. 
