News and Educations

Notice on discontinuation in the supply chain with Virolex 30 mg/1 g eye ointment (acyclovir)

22.07.2015

The marketing authorisation holder for Virolex 30 mg/1 g eye ointment (acyclovir), Krka – farma d.o.o., has notified the Agency for Medicinal Products and Medical Devices of a permanent discontinuation in the supply chain of the Croatian market with this medicine. The decision has been taken due to commercial reasons and in not related to quality, safety or efficacy of the medicine.

Virolex 30 mg/1 g eye ointment is indicated for the treatment of herpes keratitis. There is no other authorised medicinal product on the Croatian market of the same pharmaceutical form containing this active substance that is authorised for this indication. Therefore, HALMED will upon wholesaler’s request, for the treatment of patients in hospital settings or for patient named treatments, approve the enter of a medicinal product not having a marketing authorisation in Croatia.

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Notice to applicants for variations resulting from the referral for ibuprofen- and dexibuprofen-containing medicines

20.07.2015

The Co-Ordination Group for Mutual Recognition Procedure and Decentralised Procedure fur Human Medicines (CMDh) endorsed on 20 May 2015 by consensus the recommendation by EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) for ibuprofen- and dexibuprofen-containing medicines and are intended for systemic use. The recommendation is endorsed under Art. 31 of Directive 2001/83/EC of the European Parliament and Council (procedure number EMEA/H/A-31/1401) following to the referral procedure.

Further information is accessible under the link below.

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Institute of Immunology proposed corrective actions on deficiencies discovered in inspections

15.07.2015

Based on the Institute of Immunology’s application for granting manufacturing licenses for bacterial vaccines and manufacturing of blood and plasma derivatives and animal sera, in June 2015 HALMED conducted inspections in order to verify the GMP compliance.

Following to the inspection, Institute of Immunology d.d., submitted a written statement on discovered deficiencies with a proposal for corrective actions with deadlines for their implementation.

HALMED will reconsider the Institute of Immunology’s proposal and if needed, ask for additional justifications as well as evidence of undertaken measures. We would like to clarify that the deadline of 90 days until the HALMED’s decision does not count as long as the applicant has not submitted the requested justifications and evidence (clock-stop).

In spite of the public interest, we would like to emphasize that while these procedures are pending, no information could be provided as HALMED is bound to professional confidentiality.
HALMED will promptly inform the public on the results of procedures as soon as they have been completed.

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Selection procedure to appoint the Civil Society representatives in the EMA Management Board

15.07.2015

The European Commission is launching a selection procedure to appoint the Civil Society representatives in the Management Board of the European Medicines Agency (EMA), in London.

Four members from the Civil Society will be appointed: Two members representing patients’ organisations, one member representing doctors’ organisations and one member representing veterinarians’ organisations. The term of office of the current members expires on 20 March 2016.

More information is accessible under the link below.

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EMA to further clarify safety profile of human papillomavirus (HPV) vaccines

13.07.2015

The European Medicines Agency (EMA) has started a review of HPV vaccines to further clarify aspects of their safety profile. These vaccines have been used in around 72 million people worldwide and their use is expected to prevent many cases of cervical cancer (cancer of the neck of the womb) and various other cancers and conditions caused by HPV.

The current review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS).

In its review the PRAC will consider the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link. Based on this review, the Committee will decide whether to recommend any changes to product information to better inform patients and healthcare professionals. While the review is ongoing there is no change in recommendations for the use of the vaccine.

Further information is accessible under the link below.

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Dear Healthcare Professional Letter on the risk of diabetic ketoacidosis during the treatment with SGLT2 inhibitors (Invokana, Vokanamet*, Forxiga, Xigduo*, Jardiance*, Synjardy*)

10.07.2015

In agreement with the European Medicines Agency (EMA) and the Agency for Medicinal Products and Medical Devices (HALMED), AstraZeneca AB (marketing authorisation holder’s local representative: AstraZeneca d.o.o.), Boehringer Ingelheim International GmbH (marketing authorisation holder’s local representative: Boehringer Ingelheim Zagreb d.o.o.) and Janssen Cilag International N.V. (marketing authorisation holder’s local representative: Johnson & Johnson S.E. d.o.o.) would like to inform healthcare professionals on the risk of diabetic ketoacidosis during the treatment with SGLT2 inhibitors [Invokana (canagliflozin), Vokanamet* (canagliflozin/metformin), Jardiance* (empagliflozin), Synjardy* (empagliflozin/metformin)].

More information is accessible under the link below.

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Instructions on content and procedure for submitting medicinal product information in national procedure available now

03.07.2015

We would like to inform hereby marketing authorisation holder/applicants in Croatia that HALMED has published Instructions on the content and procedure for submitting medicinal product information in the national procedure.

This instruction is aimed at facilitating the creation of the most quality text proposals of product information in procedures for granting marketing authorisations, variations and upgrading. Therefore, HALMED encourages marketing authorisation holders to submit their proposals and comments on use of this instruction by e-mail to HALMED at nacionalni_QRD@halmed.hr. In order to improve this instruction, these proposals and comments will be considered by HALMED and taken into account at the next revision of this instruction.

The instruction on the content and product information submission in the national procedure may be found under the link below.

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New measures for educating patients who use adrenalin autoinjectors

01.07.2015

EMA carried out a review of adrenaline auto-injectors following concerns that currently available devices may deliver adrenaline under the skin instead of into a muscle, and this may delay response to treatment.

Having assessed all the available data, EMA’s Committee for Medicinal Products for Human Use (CHMP) acknowledged that giving the medicine by injection into the muscle is the preferred way to obtain a rapid response in anaphylaxis. However, the CHMP noted that several factors may affect whether adrenaline is actually delivered into a muscle; these include needle length, the thickness of fat under the skin, the way the auto-injector works (e.g. if it is spring loaded or not), the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection.

More information is accessible under the link below.

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