The Agency for Medicinal Products and Medical Devices (HALMED) would like to inform about the recall of the batch 140802 of Ramipril H Farmal 2.5 mg/12.5 mg tablets of the marketing authorisation holder Farmal d.d. due to a discovered quality defect.
The recall is being carried out to the pharmacy level or delivery site to patients. Patients already taking this batch of the medicine may continue to use it, as it is concluded that it has no impact on the safe use of this medicine and the recall is being ...
As of 1 October 2015, the Danish Health and Medicines Authority will change the practice for issuing Manufacturing and Importation Authorisations (MIAs) to pharmaceutical companies. This means that all manufacturing activities will be listed on the authorisation.
An MIA is issued to a pharmaceutical company that manufactures medicinal products or imports medicinal products from non-EU countries, that is countries outside the EU/EEA. At 1 October 2015, we are changing the practice for authorisations...
Following to the earlier notice on the Shortage of Propranolol Sandoz 40 mg tablets (propranolol) on the Croatian market, the marketing authorisation holder for this product, Sandoz d.o.o. has notified the Agency for Medicinal Products and Medical Devices of the shortage continuation.
The normalisation in the supply chain with Propranolol Sandoz 40 mg tablets is expected in August 2015.
More information is accessible under the link below.
The marketing authorisation holder for Zoloft 50 mg film-coated tablets (sertraline), Pfizer Croatia d.o.o., has notified the Agency for Medicinal Products and Medical Devices (HALMED) of the expected shortage of this medicine on the Croatian market. The shortage is due to the active substance, sertraline.
The normalisation of the supply chain with this medicinal product is expected by the end of 2015. There are other authorised medicinal products available with the same active substance on the Croatian...
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