Paediatric Extensions in European Countries

We recently posted a compilation of data by Martijn de Lange on drugs that had positive opinions on compliance with PIPs along with information on the corresponding SPCs in the Netherlands. Alice de Pastors has now supplemented this data with the status of paediatric extensions for selected drugs in different European countries:

1. Caspofungin

EU market authorization for Cancidas from Merck Sharp & Dohme Inc.

Paediatric extensions for caspofungin SPC

- Extensions granted until 23 or 24 April 2017 in Austria, Germany, Denmark,

France, The United-Kingdom, Greece, Ireland, Italy, The Netherlands, Sweden,

Slovenia;

- Extensions pending in Belgium, Finland, Portugal (possible expiry date

24 April 2017), Czech Republic (6 September 2017), Slovakia (7 July 2018)

- No extension data available for Bulgaria, Spain, Hungary, Luxembourg, Norway,

Poland, Romania (NO SPC pending)

- No SPC for Cyprus, Estonia, Iceland, Latvia, Lithuania, Malta.

5. Zoledronic acid

EU market authorization for Zometa from Novartis Europharm Limited

Paediatric extensions for zoledronic acid SPC

->for Novartis patents filed in November 1987 (EP275821)

- Extensions granted until 15 or 16 May 2013 in Germany, France, The United-

Kingdom, The Netherlands, Sweden, Denmark (20 May 2013),Ireland (19 May 2013),

Slovenia (8 October 2013);

- Extensions pending in Austria, Belgium, Italy (possible expiry date 16 May

2013), Finland (17 May 2013);

- No extension data available for Cyprus, Spain, Greece, Hungary, Luxembourg,

Norway, Portugal, Romania;

- No SPC in Bulgaria, Czech Republic, Estonia, Iceland, Latvia, Lithuania, Malta,

Poland.

-> for basic patent EP 258618 to Roche Diagnostics GmbH

No extension data available.

6. Losartan

National market authorization for Cozaar from Merck Sharp & Dohme Inc.

Paediatric extensions for losartan SPC

Extensions granted until 1 or 2 March 2010 in Austria, Belgium, Germany,

Denmark, Finland, France, The United-Kingdom, Ireland, Italy, The Netherlands,

Sweden, until 1 December 2010 in Latvia;

- No extension data available for Cyprus, Luxembourg, Norway.

- No SPC in other EU countries.

10. Valsartan

National market authorization for Diovan from Novartis Europharm Limited

Paediatric extensions for valsartan SPC

- Extensions until 12 November 2011 granted in The Netherlands, Sweden;

- Extensions pending in Germany, Denmark, Finland, The United-Kingdom,

(possible expiry date 12 or 13 November 2011);

- No extension data available for Austria, Belgium, France, Ireland, Italy,

Luxembourg, Latvia, Norway, Portugal;

- No SPC in other EU countries.

7.Anastrozole

National market authorization for Arimidex from AstraZeneca AB

Paediatric extensions for anastrozole SPC

- Extensions until 10, 11 or 12 February 2011 granted in Austria, Belgium,

Germany, Denmark, Finland, France, The United-Kingdom, Ireland, Italy, The

Netherlands, Sweden;

- No extension data available for Luxembourg, Norway.

- No SPC in other EU countries.

8.Abatacept

EU market authorization for Orencia from Bristol-Myers Squibb Pharma

Paediatric extensions for abatacept SPC

- Extensions until 15 or 16 December 2017 granted in Austria, Germany,

Denmark, The Netherlands, Ireland (30 December 2017);

- Extensions pending in Belgium, Finland, France, The United-Kingdom (possible

expiry date 15 or 16 December 2017);

- No extension data available for Cyprus, Spain, Greece, Hungary, Italy, Lithuania,

Luxembourg, Latvia, Norway, Portugal, Sweden, Slovenia.

- No SPC in other EU countries.