Update of product information of non-steroidal anti-inflammatory drugs (NSAID's)

The Pharmacovigilance Working Party (PhVWP) of CHMP has agreed on SPC and PL recommendations on cardiovascular safety of non-steroidal anti-inflammatory drugs. In addition, recommendations for wordings regarding gastrointestinal safety and skin reactions, as agreed by the CHMP on October 2005 and May 2006, have been prepared. National translations are provided by the NAM.

In Finland, the recommendations concern the following products:

• Indometacinum (M01AB01, M01AB51)
• Diclofenacum (M01AB05, M01AB55)
• Etodolacum (M01AB08)
• Ketorolacum trometamolum (M01AB15)
• Aceclofenacum (M01AB16)
• Tenoxicamum (M01AC02)
• Meloxicamum (M01AC06)
• Ibuprofenum (M01AE01, M01AE51)
• Naproxenum (M01AE02)
• Ketoprofenum (M01AE03)
• Acidum tiaprofenicum (M01AE11)
• Dexibuprofenum (M01AE14)
• Acidum mefenamicum (M01AG01)
• Acidum tolfenamicum (M01AG02)
• Nabumetonum (M01AX01)

National Agency for Medicines has submitted a request to the Marketing Authorisation Holders to submit type II variation applications to update the SPCs (sections 4.2, 4.3, 4.4 and 4.8 accordingly) and PLs according to the PhVWP recommendations before 28 February 2007. Wordings are requested to be implemented as such. In case of double information, the old wordings, which differ from those proposed, are to be deleted.

With regard to PL wordings, consultation with patient groups has been organised via the EMEA, and further user-testing by individual MA holders will not be expected on this occasion. Please note that the agreed wordings to the PL are provided only for the cardiovascular system. The Applicant should check and amend the PL, if necessary, so that it will also be in accordance with the new gastrointestinal and dermatological information in the SPC.

Incorporating updated PLs into new production batches will be required to start within a 3-6 month timeframe, but no later than 31 August 2007.

Variation applications are to be submitted to the Marketing Authorisation Department at the National Agency for Medicines.

For further information:
Tuomo Lapveteläinen, Senior Medical Officer, Marketing Authorisation, t. +358 9 473 341
Taina Methuen, Senior Medical Officer, Marketing Authorisation, t. +358 9 4733 4412
Kirsti Villikka, Senior Medical Officer, CMDh member, Marketing Authorisation, t. +358 9 4733 4404
Hanna Saari, Project Manager, Marketing Authorisation, t. +358 9 4733 4231

European Medicines Agency review concludes positive benefit-risk balance for non-selective NSAIDs, EMEA Press Release 24.10.2006. See also: Questions and Answers on the review of non-selective NSAIDs

Liitteet:

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Diclofenac
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SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Ibuprofen
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (OTC products) / Ibuprofen
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Ketoprofen
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (OTC products) / Ketoprofen
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Ketorolac
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Naproxen
word / pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (POM products) / Other NSAID’s
word /pdf

SPC and PL text for NSAID’s agreed by the Pharmacovigilance Working Party (PhVWP) (OTC products) / Other NSAID’s
word / pdf