The Medicines and Medical Devices Agency gave the go-ahead for the immunization of children 12 years of age and older with the Comirnaty vaccine produced by Pfizer-BioNTech. The Medicines Commission by a majority of votes approved variations of certificates for registering vaccines that include modifications to the summary of product characteristics and to medicine instructions, as regards Information about for Covid-19 Vaccine for Consumer/Patient, IPN reports.
In a press release, the Agency says the proposed changes are assessed and proposed for approval in accordance with the official WHO information about COVID-19.
Furthermore, the period of validity of the Pfizer Comirnaty frozen dispersion was proposed to be extended from six months to nine months, as the World Health Organization recommended.
In another development, the Medicines Commission authorized 57 pharmaceutical products, with 26 of these being authorized for the first time, such as Ozempic intended for diabetics, local anesthetic Orabloc and anti-asthma medicine Salbutamol.
The Commission authorized repeatedly 24 medicines, such as Finalgon, antibiotics Roclarin and Maxitrol, and approved 577 post-authorized changes to 139 medicines. It also interrupted the authorization procedures in the case of 34 medicines because the presented package of documents was incomplete and the objections formulated by the Agency’s experts weren’t dealt with on time.
