Pharmacovigilance

PRAC recommends restrictions on the use of codeine for cough and cold in children

13.03.2015

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of the risk of serious side effects with these medicines, including the risk of breathing problems.

The PRAC recommended specifically that:
• Codeine should be contraindicated in children below 12 years. This means it must not be used in this patient group.
• Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have problems with breathing.
• All liquid codeine medicines should be available in child-resistant containers to avoid accidental ingestion.

Further information is accessible under the link below.

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Recommendations for reporting variations based on the safety review from the February 2015 PRAC meeting available now

05.03.2015

The Agency for Medicinal Products and Medical Devices (HALMED) has made available on its webpages the recommendations for reporting variations based on the signal safety review adopted in the February 2015 meeting of the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC). Marketing authorisation holders are obliged to use the adopted Croatian translation when submitting variation applications.

Further information is accessible under the link below.

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Follow-up notice on reported suspected adverse reactions to the Tetanus vaccine (adsorbed), Institute of Immunology, 1 dose in Bosnia & Herzegovina

04.03.2015

The Institute of Immunology d.d., marketing authorisation holder for the Tetanus vaccine (adsorbed), Institute of Immunology, 1 dose, has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the results of a quality control of the batch 78/3 of this vaccine with the expiry date by August 2015. The Institute of Immunology has received these results from the Agency for medicines and Medical Devices of Bosnia & Herzegovina within a conducted investigation following to suspected adverse reaction reports in Bosnia & Herzegovina, which was published on 31 December 2014 on the HALMED webpages.

It is concluded that the tested samples of the Tetanus vaccine (adsorbed) comply to the approved specification with regard to the tested parameters and therefore there are no obstacles to use other packs of the batch 78/3.

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New safety information on ambroxol- and bromhexine-containing expectorants

27.02.2015

The CMDh has endorsed by majority vote recommendations to update the product information for ambroxol- and bromhexine-containing medicines with information about the small risk of severe allergic reactions and severe cutaneous adverse reactions (SCARs). The medicines are widely available in the EU for use as expectorants (to help clear mucus from the airways).

Further information is accessibe under the link below.

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CHMP News – February 2015

27.02.2015

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended three new medicines for granting a marketing authorisation and six medicines for extensions of therapeutic indications. In addition, following the CHMP’s January 2015 recommendations to suspend marketing authorisations of a number of medicines for which authorisations were primarily based on clinical studie conducted at GVK Biosciences, some marketing authorisation holders have requested a re-examination.

Further information is accessible under the link below.

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New instructions to marketing authorisation holders for variations applications based on the PRAC recommendations following a signal safety review

26.02.2015

Following the Pharmacovigilance Risk Assessment Committee (PRAC) January 2015 meeting, the European Medicines Agency (EMA) is publishing on its webpages translations of all texts in the EU official languages that should be included in the product information and that are related to medicines authorised via national or centralised procedure. When applying for a variation, marketing authorisation holders are obliged to use the adopted Croatian translation that is available on the HALMED's webpages.

Further information is accessible under the link below.

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Presentations from the workshop „OTC Medicines: The role of good classification practices in promoting medication safety and accessibility in Europe“

27.01.2015

The Council of Europe's European Directorate for the Quality of Medicines and Healthcare (EDQM) has publishedon its website presentations held at the workshop „OTC Medicines: The role of good classification practices in promoting medication safety and accessibility in Europe“.

More information is accessible under the link below.

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