The Main Pharmaceutical Inspectorate decided to withdraw from the market as many as ten series of Pentaerythritol compositum from the market. It is recommended for patients with cardiovascular diseases.
The Main Pharmaceutical Inspector decided to withdraw several series from the market Pentaerythritol compositum (Glyceroli trinitras + Pentaeritrityli tetranitras) tabletki (0,5 mg + 0,20 mg).
Retired Series:
batch number: 010117, expiry date: 07.2018
batch number: 020117, expiry date: 07.2018
batch number: 010217, expiry date: 08.2018
batch number: 020217, expiry date: 08.2018
batch number: 010517, expiry date: 10.2018
batch number: 020517, expiry date: 10.2018
batch number: 050517, expiry date: 10.2018
batch number: 020817, expiry date: 02.2019
batch number: 030817, expiry date: 02.2019
batch number: 050817, expiry date: 02.2019.
The responsible entity is the PHARMACEUTICAL WORK COOPERATIVE “GALENA”.
The decision was made immediately enforceable.
«On July 13, the Main Pharmaceutical Inspectorate received an application from the MAH to withdraw the above-mentioned batch of the medicinal product. The MAH’s own decision was made in connection with the fact that, during the stability studies, results were obtained outside the specification for the parameter content of the active substance glyceryl and trinitrate », reads the GIF release.
Indications for use of the drug:
Chronic coronary artery disease, coronary failure after myocardial infarction.