Information to the Marketing Authorisation Holder – Docetaxel (with alcohol in formulation) - 30.12.2014

Referral Art. 107i, EMEA/H/C/PSUSA/1152/201311 regarding Docetaxel (with alcohol in formulation) was finalised 23 December 2014.

Information to the Marketing Authorisation Holder – Oxynal-Targin and associated names - 30.12.2014

Referral Art. 13, EMEA/H/A-13/1402 regarding Oxynal-Targin and associated names was finalised 23 December 2014.

Information to the Marketing Authorisation Holder – Plendil and associated names - 30.12.2014

Referral Art. 30, EMEA/H/A-30/1385 regarding Plendil and associated names was finalised 17 December 2014.

The IMA over Christmas and New Year - 19.12.2014

The Icelandic Medicines Agency will be closed 24, 25, 26 and 31 December 2014 and 1 January 2015.

Information to the Marketing Authorisation Holder – Emla cream - 12.12.2014

Referral Art. 30, EMEA/H/A-30/1388 regarding Emla cream was finalised 1 December 2014.

Information to Marketing Authorisation Holders: The abbreviations “Lot” og “EXP” in labelling - 26.9.2014

The European Medicines Agency publishes a document with terms/abbreviations for ”batch number” and “expiry date” which can be used on packages of veterinary medicinal products.

Information to the Marketing Authorisation Holders - Renin-angiotensin system acting agents  - 18.9.2014

Referral Art. 31, EMEA/H/A-31/1370 regarding RAS (Renin-angiotensin system) -acting agents was finalised 8 September 2014.

IMA closed Friday 19 September from 12:00 – 16:00 - 17.9.2014

The Icelandic Medicines Agency will be closed Friday 19 September from 12:00 – 16:00, due to an annual Out-of-office Workshop by staff.

IMA's Annual Report 2013 - 24.7.2014

IMA´s Annual Report 2013 has been published on the website.

Information to the Marketing Authorisation Holder – Zolpidem - 23.7.2014

Referral Art. 31, EMEA/H/A-31/1377 regarding Zolpidem was finalised 24 June 2014.

IMA publishes data about drug consumption in Iceland 2009-2013 - 22.4.2014

The published data contains information about drug consumption in Iceland from 2009 -2013.

IMA‘s new website launched yesterday - 14.3.2014

Sveinn Magnússon Director General at the Ministry of Welfare visited the IMA yesterday and launched its new website.

Receipt of clinical trial applications (CTA) summer 2014 - 27.2.2014

Due to summer holiday the Icelandic Medicines Agency (IMA) will not confirm receipt of clinical trial applications (CTA) from 23 June to 11 August 2014.

The Nordic Medicinal Agencies release Guidance on Nordic packages - 21.1.2014

The new documents Guideline on Nordic packages and Frequently Asked Questions have been prepared in order to facilitate the regulatory work when making common Nordic medicinal packages.

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