• Home
  • Legal Notices and Terms of Use
  • Sitemap
  • Contacts
  • Hrvatski
 
Search
Newsletter
Enquiries
Rapid Alert System
Generic Medicinal Products and Interchangeability
Application Web ponude
bullet News
bullet About Us
bullet Fees
bullet Public Procurement
bullet Central Ethics Committee
bullet International Cooperation
bullet Seminars and Workshops
bullet Useful Links
bullet Legislation
bullet Publications and Reports
bullet Forms
bullet Approval for the Import
bullet Job and Career
bullet MRP and DCP procedures
bullet Contacts
SPC and PIL
Latest Information
Quality Policy
Code of Conduct
Freedom of Information
User Satisfaction
Complaints Procedure
RSS - Really Simple Syndication
Season's Greetings
Informacije o lijekovima
On-line prijava nuspojava
Read a Patient Information Leaflet Report Side Effects to Medicines
News

Newly approved medicinal products
17.12.2014.

The list of newly approved medicinal products for the period between 1st November 2014 and 30th November 2014 is available in the continuation of this notice.

[more]

Dear Healthcare Professional Letter on recommended loading dose and maintenance dose for Efient (prasugrel) due to an increased risk of serious bleeding
16.12.2014.

Eli Lilly Croatia d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform healthcare professionals on the recommended loading dose and maintenance dose for Efient (prasugrel) due to an increased risk of serious bleeding.

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

[more]

Visit of HALMED delegation to the Kosovo Medicines Agency (AKPPM)
11.12.2014.

Upon invitation by the Kosovo Head of Agency, Mr Arianit Jakupi, a delegation of the Agency for Medicinal Products and Medical Devices (HALMED) led by the Head of Agency, Dr Viola Macolić Šarinić, MD, PhD, visited from 8 to 9 December 2014 the Kosovo Medicines Agency (AKPPM). HALMED and the AKPPM concluded a mutual collaboration agreement in 2013 in the field of the OMCL and regulatory affairs regarding medicines authorisation and pharmacovigilance.

The Croatian delegation was also received on 9 December 2014 by the Kosovo Minister of Health, Professor Ferid Agani for a brief discussion confirming that the Kosovo Medicines Agency would recognise all marketing authorisations issued by HALMED without repeating the assessment and thus speeding up and facilitating the granting of marketing authorisations for medicinal products of Croatian manufacturers in Kosovo. This provision is set out in the new ordinance on granting a marketing authorisation that is pending and is under the responsibility of the Kosovo Ministry of Health. This agreement paves the way for Croatian pharmaceutical manufacturers to place their medicinal products on the Kosovo market, as HALMED is being recognised as a safe and responsible partner in the regulatory environment of the region, ensuring efficacious, quality and safe medicines to all patients and users.

[more]

Dear Healthcare Professional Letter on new contraindications and recommendations for minimising risks from cardiovascular events and severe bradycardia associated with the use of Procoralan and Corlentor (ivabradine)
10.12.2014.

Servier Pharma d.o.o., the local marketing authorisation holder’s representative for Procoralan and Corlentor (ivabradine), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform healthcare professionals on the recommendations for use of ivabradine to minimise the risk from cardiovascular events and severe bradycardia.

More information and the Dear Healthcare Professional Letter are accessible under the link below.

[more]

Dear Healthcare Professional Letter on the revised contraindications and warnings and precautions for the use of SonoVue (sulphur hexafluoride)
09.12.2014.

Bracco International BV, in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) would like to inform health care professionals on the revised contraindications and warnings and precautions for the use of SonoVue (sulphur hexafluoride).

More information and the Dear healthcare Professional Letter are accessible under the link below.

[more]

Notice on quality defect of the batch H55110 of Prevenar 13
08.12.2014.

Pfizer Croatia d.o.o., the representative of the marketing authorisation holder in the Republic of Croatia for Prevenar 13 has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the quality defect of the batch H55110 of this medicinal product. It is discovered that the package leaflet for Prevenar 13 in single dose vial (0.5 ml) is inserted in the packaging for Prevenar 13 in single dose pre-filled syringe (0.5 ml). These two package leaflets differ in the title and in the section "How Prevenar 13 appears and package content”. Both vaccines are already ready for use, but when administering the vaccine in single dose vial, the solution should be aspirated into the syringe.
HALMED agrees that the marketing authorisation holder’s representative distributes these batches with accompanying notes intended to wholesalers, healthcare professionals and patients as well as the correct package leaflet.

[more]

MRP i DCP postupci
Croatian Pharmacopoeia
Scope
Events - HALMED

Zagreb, 10 and 11 February 2015
The Pharmacovigilance Workshop: Risk Management, Electronic Reporting, XEVMPD updates

The Pharmacovigilance Workshop: Risk Management, Electronic Reporting, XEVMPD updates will be organised from on the 10 and 11 February 2015 in Zagreb.

Details on fees, venue of the workshop and registration are accessible in the registration form by which all interested participants may register. The workshop programme is accessible under the link below.

[more]

Educational course “Distribution of medical devices”

The Agency for Medicinal Products and Medical Devices (HALMED) is organising in Zagreb an educational course “Distribution and good practice in medical device distribution”. The course will be held at the HALMED’s premises, Ksaverska cesta 4, and the exact date of the course will be determined when enough interested participants has gathered (the foreseen duration 6 school hours). The course is intended to wholesalers of medical devices and authorised manufacturer’s representatives from the third countries.

[more]

Educational course “Introduction to medical devices vigilance”

The educational course “Introduction to medical devices vigilance”, organised by the Agency for Medicinal Products and Medical Devices (HALMED), will take place at the HALMED’s premises at Ksaverska cesta 4. The exact date will be announced when enough interested participants have been gathered (the approximate duration is 6 school hrs).
More information is available in the continuation of this information.

[more]