News | News and Educations .: HALMED

Dear Healthcare Professional Letter on the importance of the wild type RAS status determination (exons 2, 3 and 4 of KRAS and NRAS) prior to Erbitux (cetuximab) treatment

07.01.2014

Merck Serono has, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED), sent out a letter to healthcare professionals about the variation in the authorised indication of Erbitux in metastatic colorectal cancer (mCRC).

Detailed information and the Dear Healthcare Professional Letter is available under the link below.

Information on voluntary recall of the one batch of the medicinal product Esomeprasol PharmaS 40 mg gastro-resistant tablets

02.01.2014

PharmaS d.o.o., the marketing authorisation holder and manufacturer for the medicinal product Esimeprazol PharmaS 40 mg gastro-resistant tablets, has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the voluntary recall from wholesalers of the batch 3880213 of this medicinal product.
The recall of the aforementioned batch is being carried out due to a labelling error of the dose on the lateral package side, where it is indicated 20 mg instead of 40. The reason for recall is a possible mistake at dispensing and therefore a possibility for the patient to take a wrong dose of the medicine.
Detailed information is available under the link below.

Launch of a new version of the application form for dossier upgrading

01.01.2014

The Agency for Medicinal Products and Medical devices (HALMED) is informing marketing authorisation holders about the new version of the application form for dossier upgrading, that should be attached to the request for dossier upgrading.

Detailed information and the new version of the Application form are available under the following link.