Orally administered isotretinoin is highly teratogenic and strictly contraindicated in pregnancy. Reliable pregnancy prevention is therefore essential when using isotretinoin (Ciscutan®, various generics). Prescribing, dispensing and taking…

The distribution company has informed its supplied customers by letter dated August 29, 2011, that the batches indicated above may be contaminated with particles and are therefore recalled as a precautionary measure.

With the new DCP-slot alert mailing list applicants have the opportunity to be informed immediately whenever a new version of the availability matrix has been published. In the availability matrix free resources in the different assessor groups for…

The marketing authorization holder has informed its supplied customers by letter dated 23.08.2011 that a replacement will be carried out due to crystallization of the calcium solution. Note: On 06.06.2011, the batches L108003 and L118002 were already…

The marketing authorization holder informed its supplied customers in a letter dated August 12, 2011, that individual tablets may break when they are pressed out of the blister and that this batch will therefore be replaced.

The marketing authorization holder informed its supplied customers in a letter dated August 9, 2011, that the release of the active ingredient may be accelerated in the three batches mentioned and that a replacement will therefore be carried out as a…

On 05.08.2011, the Federal Office for Safety in Health Care sent a draft of the "Regulation of the Federal Office for Safety in Health Care amending the Regulation of the Federal Office for Safety in Health Care on the Fee Tariff pursuant to the GESG…

On August 5, 2011, the Federal Office for Safety in Health Care sent a draft of the "Ordinance of the Federal Office for Safety in Health Care on the Collection, Payment and Determination of the Amount of a Medical Device Fee (Medical Device Fee…

The marketing authorization holder informed its supplied customers in a letter dated July 7, 2011, that another batch that had exceeded the 18-month shelf life would be replaced. Already on April 12, 2011, batches were withdrawn from the market after…

In a letter dated July 13, 2011, the marketing authorization holder informed its supplied customers that, in addition to the tablets, glass splinters may also be present in the amber glass vials. These particles are caused by chipping of the bottle…