Pharmacovigilance

CHMP and CMD news – December 2013

23.12.2013

The CMDh has endorsed the PRAC recommendation about the restriction of use of apimox-containing medicinal products.
The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has adopted the PRAC recommendations for medicinal products Kogenate Bayer and Helixate Nexgen, recommended approval of the medicinal product for the treatment of multiresistant tuberculosis, recommended approval of five new medicines, adopted a positive scientific opinion for Tritanrix HB and adopted a recommendation for extension of therapeutic indications for Jentadueto.

More information is available under the following link.

more

Dear Healthcare Professional letter on the safe use of the medicinal product Peyona (caffeine citrate)

11.12.2013

The company Chiesi Farmacutici S.p.A., marketing authorisation holder for the medicinalproduct Peyona 20 mg/ml solution for infusion and oral solution, has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent a letter with relevant information to healthcare professionals concerning the safe use of this medicinal product.

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

more

Information about the recall of the batch 10714 B-2 of the medicinal product Bucain-Actavis 0.5% hyperbar (bupivacaine hydrochloride)

10.12.2013

The applicant for interventional import of the medicinal product Bucain-Actavis 0.5 % hyperbar (bupivacaine hydrochloride), Medika d.d., has, at the request of the Agency for Medicinal Products and Medical Devices (HALMED) initiated a recall of the batch 10714 B-2 of this product from the Croatian market.
The recall procedure of this batch started after the 9 December 2013, when HALMED received a report to a suspected quality defect associated with a report to a suspected adverse reaction. The report to a suspected adverse reaction indicated a shortened duration of anaesthesia (20-30 min duration of blocks), independent from the dose and application technique, appearance of shudders, mild pain and uneasiness in arms after administration in four patients.
HALMED has asked the Ministry of Health to sample the aforementioned product batch.

Detailed information is available under the following link below.

more

Dear Healthcare Professional Letter on the important changes to frequency of serum liver test monitoring for hepatotoxicity in patients treated with Votrient (pazopanib)

06.12.2013

The company Glaxo Smith Kline d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) has sent a letter to healthcare professionals on the new, important recommendations related to frequency of serum liver test monitoring for hepatotoxicity i patients treated with pazopanib.

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

more

Dear Healthcare Professional Letter about the haemophagocytic syndrome reported in patients treated with fingolimod (Gilenya)

15.11.2013

Novartis Europharm Limited, the marketing authorisation holder for the medicinal product Gilenya 0.5 mg hard capsules (fingolimod), has in collaboration with the Agency for Medicinal Products and Medical Devices sent out a letter to healthcare professionals about the two reported fatal cases of haemophagocytic syndrome in patients with multiple sclerosis (MS) treated with fingolimod.
For more information please follow the link below.

more

Dear Healthcare Professional Letter about the introduction of new contraindications and warnings after cardiovascular safety assessment of diclofenac in the EU Member States

15.11.2013

Farmal d.d., Fresenius Kabi d.o.o., Krka – farma d.o.o, PharmaSwiss d.o.o., Pliva Hrvatska d.o.o. and Sandoz d.o.o., marketing authorisation holders for systemic formulations of diclofenac-containing medicinal products in the Republic of Croatia, have in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals about important restrictions of use of diclofenac-containing medicinal products, following cardiovascular safety assessment in the EU Member States.

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

more

Dear Healthcare Professional Letter on the shortage of the medicinal product Pedea and information about an alternative treatment

15.11.2013

Orphan Europe, the marketing authorisation holder for the medicinal product Pedea 5 mg/ml solution for injection (ibuprofen), has in collaboration with the Agency for Medicinal Products and Medical devices (HALMED) sent a letter to healthcare professionals on the interruption in the supply of the European market with this medicine. this is due to visible particles forming in the vials after production which has been detected only in bathes that have not been released on the market . It is estimated that the shortage will last by the end of 2013. This letter give further information to healthcare professionals about an alternative medicinal product unlicensed in the EU, but imported from the United States in agreement with HALMED and other competent authorities. The letter gives also advice to healthcare professionals regarding precautions to be used when prescribing the alternative unlicensed product in the EU for the indication concerned.

Detailed information and the letter are available under the link below.

more

Dear Healthcare Professionals Letter about a restriction of use of hydroxyethyl-starch (HES): Tetraspan, Voluven and Volulyte

14.11.2013

B. Braun Adria d.o.o. and Fresenius Kabi d.o.o., the marketing authorisation holders for hydroxyethyl-starch-containing medicinal products (Tetraspan 60 and 100 mg/ml solution for infusion, Voluven 6% solution for infusion, Volulyte 6% solution for infusion) have in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals about new restrictions of use of hydroxyethyl-starch-containing medicinal products (HES) based on the benefits/risks ratio assessment carried out recently in the EU.
Detailed information and the Dear Healthcare Professional Letter are avaiable under the link below.

more

For Patients and Public

For Health Care Professionals

For Industry Representatives