SFDA Warns Against Using the Batch Number (MC1605) of "Biotrue Multi-Purpose Solution" as it is Possible to Lead to Conjunctivitis
2019-01-20
SFDA Captured Violations in 108 Pharmaceutical Products Warehouses in three months.
SFDA announced that its specialists conducted periodical inspection tours to the warehouses of drug importers and promotes, in line with SFDA efforts in tracing pharmaceutical products marked in the Kingdom to insure their safety, quality and efficacy and compliance to storage and distribution conditions approved by SFDA.
SFDA inspectors detected 1411 violating products in a number of Attarat’s stores during thier inspection tours. In a statement SFDA cleared that it’s inspection teams checked a number of Attarat’s stores in Riyadh as part of their inspection program of pharmaceutical products that have medical claims illegally traded in the local market where they captured 1411 violated products.
The Saudi Food and Drug Authority would like to inform the healthcare professionals and the public that after reviewing the safety profile for products containing ambroxol and bromhexine (secretolytic agents of acute and chronic bronchopulmonary diseases), it has been found that these drugs might be associated with rare but severe allergic reactions such as anaphylactic shock.
SFDA welcomed at its Head Office a student delegation from the faculty of Medicine & Pharmacology of Al Majma’ah University, on Tuesday 2/4/1434H.
The Saudi Food and Drug Authority (SFDA) would like to share some recent information regarding use of Diane 35® (cyproterone acetate 2 mg + ethinyl estradiol 35 micrograms). On 30/01/2013, the French medicines agency (ANSM) announced that they decided to suspend the marketing authorisation for Diane 35® and its generics for acne treatment in France within three months. This decision was based on review of known data by the French medicines agency.
The European Committee for Medicinal Products for Human Use (CHMP) has
reviewed the risk of nephrogenic systemic fibrosis (NSF) with gadolinium containing
contrast agents.
On the basis of current evidence, the risk classification is as follows:
High risk—Omniscan (gadodiamide), OptiMARK (gadoversetamide),Magnevist (gadopentetic acid)
Medium risk—MultiHance (gadobenic acid), Primovist (gadoxetic acid),
Vasovist (gadofosveset)