• 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
Informacije o lijekovima
On-line prijava nuspojava
Čitajte uputu o lijeku Prijavite nuspojave na lijekove
News

Registration for the international regulatory and pharmacovigilance conference “Croatian Mark in the EU” started
26.09.2014.

The Agency for Medicinal Products and Medical Devices (HALMED) organises the international regulatory and pharmacovigilance conference entitled "Croatian Mark in the EU” which will be held from 11 to 12 November 2013 in Hotel Ivan, Solaris, in Šibenik.

The registration for the conference started today, 26 September 2014. All interested for participation may register via registration form, which is, along with detailed information, accessible at the HALMED's webpages in the Conferences and workshops/Regulatory and pharmacovigilance conference "Croatian Mark in the EU" section, or under the link below.

[more]

HALMED's Development Strategy 2014-2018 - text released
20.10.2014.

The Agency for Medicinal Products and Medical Devices (HALMED) released the text of Development Strategy for period 2014-2018. The text is available on HALMED's Internet pages in About Us section.

[more]

Newly approved medicinal products
17.10.2014.

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

[more]

EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)
14.10.2014.

The European Medicines Agency has completed a review of the anti-depressant medicine Valdoxan/Thymanax and concluded that its benefits continue to outweigh the risks. However, the EMA has recommended that further measures should be put in place to minimise the risk of liver toxicity. Valdoxan and Thymanax are two identical medicines used to treat major depression in adults.

More information is accessible under the link below.

[more]

PRAC recommends strengthening the restrictions on the use of valproate in women and girls
14.10.2014.

The PRAC has recommended strengthening the restrictions on the use due to risks of congenital malformations and development problems in children exposed to valproate during pregnancy. The PRAC has recommended that valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated.

Valproate has been used to treat epilepsy and bipolar disorder. Some valproate medicines are also authorised in some EU Member States, Croatia included, to prevent migraine headaches.

More information is accessible under the link below.

[more]

PRAC News – October 2014
14.10.2014.

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended strengthening the restrictions on the use of valproate in women and girls, concluded that there is no evidence that testosterone-containing medicines increase the cardiovascular risk in patients with hypogonadism and recommended further measures to minimise risk of blood vessel blockage with ponatinib at its October 2014 meeting.

More information is accessible under the link below.

[more]

MRP i DCP postupci
Croatian Pharmacopoeia
Scope
Events - HALMED

Šibenik, 11-12 November 2014
International regulatory and pharmacovigilance conference "Croatian Mark in the EU"

The Agency for Medicinal Products and Medical Devices (HALMED) organises the international regulatory and pharmacovigilance conference entitled “Croatian Mark in the EU” which will be held from 11 to 12 November 2013 in Hotel Ivan, Solaris, in Šibenik.

The registration for the conference started today, 26 September 2014. All interested for participation may register via registration form, which is, along with detailed information, 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]