# Official Journal C 251/2007

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 251 |
| | |
| English edition | Information and Notices | Volume 5026 October 2007 |

ISSN 1725-2423

Official Journal

of the European Union

C 251

English edition

Information and Notices

Volume 5026 October 2007

---

| Notice No | Contents | page |
| --- | --- | --- |
| | I   Resolutions, recommendations and opinions |
| | OPINIONS |
| | Commission |
| 2007/C 251/01 | Commission opinion of 24 October 2007 concerning the plan for the disposal of radioactive waste arising from the decommissioning of the Garagliano nuclear power plant, located in Italy, in accordance with Article 37 of the Euratom Treaty | 1 |
| 2007/C 251/02 | Commission opinion of 24 October 2007 concerning the plan for the disposal of radioactive waste arising from the decommissioning of the Trino nuclear power plant, located in Italy, in accordance with Article 37 of the Euratom Treaty | 2 |

Notice No

Contents

page

I   Resolutions, recommendations and opinions

OPINIONS

Commission

2007/C 251/01

Commission opinion of 24 October 2007 concerning the plan for the disposal of radioactive waste arising from the decommissioning of the Garagliano nuclear power plant, located in Italy, in accordance with Article 37 of the Euratom Treaty

1

2007/C 251/02

Commission opinion of 24 October 2007 concerning the plan for the disposal of radioactive waste arising from the decommissioning of the Trino nuclear power plant, located in Italy, in accordance with Article 37 of the Euratom Treaty

2

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2007/C 251/03 | Euro exchange rates | 3 |
| 2007/C 251/04 | Opinion of the Advisory Committee on restrictive practices and dominant positions given at its 398th meeting on 21 November 2005 concerning a draft decision in Case COMP/38354 — Industrial bags | 4 |
| 2007/C 251/05 | Opinion of the Advisory Committee on restrictive practices and dominant positions given at its 399th meeting on 28 November 2005 concerning a draft decision in Case COMP/38354 — Industrial bags | 4 |
| 2007/C 251/06 | Opinion of the Advisory Committee on concentrations given at its 142nd meeting on 20 July 2006 concerning a draft decision relating to Case COMP/M.3848 — Sea-Invest/EMO-EKOM | 5 |
| 2007/C 251/07 | Final report of the Hearing Officer in Case COMP/M.3848 — Sea-Invest/EMO-EKOM (Pursuant to Articles 15 and 16 of Commission Decision 2001/462/EC, ECSC of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21) | 6 |
| 2007/C 251/08 | Final report of the Hearing Officer in Case COMP/38354 — Industrial bags (Pursuant to Articles 15 and 16 of Commission Decision 2001/462/EC, ECSC of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21) | 7 |
| 2007/C 251/09 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2007 to 30 September 2007(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 10 |
| 2007/C 251/10 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2007 to 30 September 2007(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council) | 16 |
| | NOTICES FROM MEMBER STATES |
| 2007/C 251/11 | Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 70/2001 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises (
  1
  ) | 103 |
| 2007/C 251/12 | Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1628/2006 on the application of Articles 87 and 88 of the Treaty to national regional investment aid (
  1
  ) | 108 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2007/C 251/03

Euro exchange rates

3

2007/C 251/04

Opinion of the Advisory Committee on restrictive practices and dominant positions given at its 398th meeting on 21 November 2005 concerning a draft decision in Case COMP/38354 — Industrial bags

4

2007/C 251/05

Opinion of the Advisory Committee on restrictive practices and dominant positions given at its 399th meeting on 28 November 2005 concerning a draft decision in Case COMP/38354 — Industrial bags

4

2007/C 251/06

Opinion of the Advisory Committee on concentrations given at its 142nd meeting on 20 July 2006 concerning a draft decision relating to Case COMP/M.3848 — Sea-Invest/EMO-EKOM

5

2007/C 251/07

Final report of the Hearing Officer in Case COMP/M.3848 — Sea-Invest/EMO-EKOM (Pursuant to Articles 15 and 16 of Commission Decision 2001/462/EC, ECSC of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

(Pursuant to Articles 15 and 16 of Commission Decision 2001/462/EC, ECSC of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

6

2007/C 251/08

Final report of the Hearing Officer in Case COMP/38354 — Industrial bags (Pursuant to Articles 15 and 16 of Commission Decision 2001/462/EC, ECSC of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

(Pursuant to Articles 15 and 16 of Commission Decision 2001/462/EC, ECSC of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

7

2007/C 251/09

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2007 to 30 September 2007(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  )

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council

)

10

2007/C 251/10

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2007 to 30 September 2007(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council)

16

NOTICES FROM MEMBER STATES

2007/C 251/11

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 70/2001 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises (
  1
  )

1

103

2007/C 251/12

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1628/2006 on the application of Articles 87 and 88 of the Treaty to national regional investment aid (
  1
  )

1

108

| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2007/C 251/13 | Prior notification of a concentration (Case COMP/M.4936 — BENTELER/SGLT/JV) (
  1
  ) | 110 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2007/C 251/13

Prior notification of a concentration (Case COMP/M.4936 — BENTELER/SGLT/JV) (
  1
  )

1

110

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(1)   Text with EEA relevance

1

| EN | |
| --- | --- |

EN

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I Resolutions, recommendations and opinions

OPINIONS

Commission

| 26.10.2007 | EN | Official Journal of the European Union | C 251/1 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/1

---

COMMISSION OPINION

of 24 October 2007

concerning the plan for the disposal of radioactive waste arising from the decommissioning of the Garagliano nuclear power plant, located in Italy, in accordance with Article 37 of the Euratom Treaty

(Only the Italian text is authentic)

(2007/C 251/01)

On 15 January 2007, the European Commission received from the Government of Italy, in accordance with Article 37 of the Euratom Treaty, General Data relating to the plan for the disposal of radioactive waste arising from the decommissioning of the Garigliano nuclear power plant.

On the basis of these data, and following consultation with the Group of Experts, the Commission has drawn up the following opinion:

| 1. | The distance between the plant and the nearest point of another Member State, in this case France (Corsica), is approximately 340 km. |
| --- | --- |

1.

The distance between the plant and the nearest point of another Member State, in this case France (Corsica), is approximately 340 km.

| 2. | During normal decommissioning operation, discharges of liquid and gaseous effluents will not cause an exposure liable to affect the health of the population in other Member States. |
| --- | --- |

2.

During normal decommissioning operation, discharges of liquid and gaseous effluents will not cause an exposure liable to affect the health of the population in other Member States.

| 3. | Solid radioactive waste produced during decommissioning will be stored in a facility on site before final disposal in a planned national repository. Non-radioactive solid waste and materials in compliance with clearance levels will be released from regulatory control for disposal as conventional waste or for recycling or reuse. This will be done in compliance with the criteria laid down in the Basic Safety Standards (Council Directive 96/29/Euratom). |
| --- | --- |

3.

Solid radioactive waste produced during decommissioning will be stored in a facility on site before final disposal in a planned national repository. Non-radioactive solid waste and materials in compliance with clearance levels will be released from regulatory control for disposal as conventional waste or for recycling or reuse. This will be done in compliance with the criteria laid down in the Basic Safety Standards (Council Directive 96/29/Euratom).

| 4. | In the event of unplanned releases of radioactive waste, which may follow an accident of the type and magnitude considered in the General Data, the doses received in other Member States would not be liable to affect the health of the population. |
| --- | --- |

4.

In the event of unplanned releases of radioactive waste, which may follow an accident of the type and magnitude considered in the General Data, the doses received in other Member States would not be liable to affect the health of the population.

In conclusion, the Commission is of the opinion that the implementation of the plan for the disposal of radioactive waste in whatever form arising from the decommissioning of the Garigliano nuclear power plant, located in Italy, both in normal operation and in the event of an accident of the type and magnitude considered in the General Data, is not liable to result in the radioactive contamination of the water, soil or airspace of another Member State.

---

| 26.10.2007 | EN | Official Journal of the European Union | C 251/2 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/2

---

COMMISSION OPINION

of 24 October 2007

concerning the plan for the disposal of radioactive waste arising from the decommissioning of the Trino nuclear power plant, located in Italy, in accordance with Article 37 of the Euratom Treaty

(Only the Italian text is authentic)

(2007/C 251/02)

On 15 January 2007, the European Commission received from the Government of Italy, in accordance with Article 37 of the Euratom Treaty, General Data relating to the plan for the disposal of radioactive waste arising from the decommissioning of the Trino nuclear power plant.

On the basis of these data, and following consultation with the Group of Experts, the Commission has drawn up the following opinion:

| 1. | The distance between the plant and the nearest point of another Member State, in this case France, is approximately 190 km. |
| --- | --- |

1.

The distance between the plant and the nearest point of another Member State, in this case France, is approximately 190 km.

| 2. | During normal decommissioning operation, discharges of liquid and gaseous effluents will not cause an exposure liable to affect the health of the population in other Member States. |
| --- | --- |

2.

During normal decommissioning operation, discharges of liquid and gaseous effluents will not cause an exposure liable to affect the health of the population in other Member States.

| 3. | Solid radioactive waste produced during decommissioning will be stored in a facility on site before final disposal in a planned national repository. Non-radioactive solid waste and materials in compliance with clearance levels will be released from regulatory control for disposal as conventional waste or for recycling or reuse. This will be done in compliance with the criteria laid down in the Basic Safety Standards (Council Directive 96/29/Euratom). |
| --- | --- |

3.

Solid radioactive waste produced during decommissioning will be stored in a facility on site before final disposal in a planned national repository. Non-radioactive solid waste and materials in compliance with clearance levels will be released from regulatory control for disposal as conventional waste or for recycling or reuse. This will be done in compliance with the criteria laid down in the Basic Safety Standards (Council Directive 96/29/Euratom).

| 4. | In the event of unplanned releases of radioactive waste, which may follow an accident of the type and magnitude considered in the General Data, the doses received in other Member States would not be liable to affect the health of the population. |
| --- | --- |

4.

In the event of unplanned releases of radioactive waste, which may follow an accident of the type and magnitude considered in the General Data, the doses received in other Member States would not be liable to affect the health of the population.

In conclusion, the Commission is of the opinion that the implementation of the plan for the disposal of radioactive waste in whatever form arising from the decommissioning of the Trino nuclear power plant, located in Italy, both in normal operation and in the event of an accident of the type and magnitude considered in the General Data, is not liable to result in the radioactive contamination of the water, soil or airspace of another Member State.

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 26.10.2007 | EN | Official Journal of the European Union | C 251/3 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/3

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Euro exchange rates (1)

25 October 2007

(2007/C 251/03)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,4309 |
| JPY | Japanese yen | 163,64 |
| DKK | Danish krone | 7,4546 |
| GBP | Pound sterling | 0,69765 |
| SEK | Swedish krona | 9,2103 |
| CHF | Swiss franc | 1,6701 |
| ISK | Iceland króna | 86,68 |
| NOK | Norwegian krone | 7,7300 |
| BGN | Bulgarian lev | 1,9558 |
| CYP | Cyprus pound | 0,5842 |
| CZK | Czech koruna | 27,114 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 250,79 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7029 |
| MTL | Maltese lira | 0,4293 |
| PLN | Polish zloty | 3,6275 |
| RON | Romanian leu | 3,3465 |
| SKK | Slovak koruna | 33,270 |
| TRY | Turkish lira | 1,7121 |
| AUD | Australian dollar | 1,5813 |
| CAD | Canadian dollar | 1,3785 |
| HKD | Hong Kong dollar | 11,0912 |
| NZD | New Zealand dollar | 1,8902 |
| SGD | Singapore dollar | 2,0832 |
| KRW | South Korean won | 1 312,14 |
| ZAR | South African rand | 9,4439 |
| CNY | Chinese yuan renminbi | 10,7060 |
| HRK | Croatian kuna | 7,3440 |
| IDR | Indonesian rupiah | 13 099,89 |
| MYR | Malaysian ringgit | 4,8007 |
| PHP | Philippine peso | 63,031 |
| RUB | Russian rouble | 35,5030 |
| THB | Thai baht | 45,145 |

Currency

Exchange rate

USD

US dollar

1,4309

JPY

Japanese yen

163,64

DKK

Danish krone

7,4546

GBP

Pound sterling

0,69765

SEK

Swedish krona

9,2103

CHF

Swiss franc

1,6701

ISK

Iceland króna

86,68

NOK

Norwegian krone

7,7300

BGN

Bulgarian lev

1,9558

CYP

Cyprus pound

0,5842

CZK

Czech koruna

27,114

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

250,79

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7029

MTL

Maltese lira

0,4293

PLN

Polish zloty

3,6275

RON

Romanian leu

3,3465

SKK

Slovak koruna

33,270

TRY

Turkish lira

1,7121

AUD

Australian dollar

1,5813

CAD

Canadian dollar

1,3785

HKD

Hong Kong dollar

11,0912

NZD

New Zealand dollar

1,8902

SGD

Singapore dollar

2,0832

KRW

South Korean won

1 312,14

ZAR

South African rand

9,4439

CNY

Chinese yuan renminbi

10,7060

HRK

Croatian kuna

7,3440

IDR

Indonesian rupiah

13 099,89

MYR

Malaysian ringgit

4,8007

PHP

Philippine peso

63,031

RUB

Russian rouble

35,5030

THB

Thai baht

45,145

---

(1)

Source: reference exchange rate published by the ECB.

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| 26.10.2007 | EN | Official Journal of the European Union | C 251/4 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/4

---

Opinion of the Advisory Committee on restrictive practices and dominant positions given at its 398th meeting on 21 November 2005 concerning a draft decision in Case COMP/38354 — Industrial bags

(2007/C 251/04)

| 1. | The Advisory Committee agrees with the European Commission's assessment of the products and the geographic area affected by the cartel in the draft decision. |
| --- | --- |

1.

The Advisory Committee agrees with the European Commission's assessment of the products and the geographic area affected by the cartel in the draft decision.

| 2. | The Advisory Committee agrees with the European Commission's legal assessment of the facts as an agreement and/or concerted practice infringing Article 81(1) of the Treaty. |
| --- | --- |

2.

The Advisory Committee agrees with the European Commission's legal assessment of the facts as an agreement and/or concerted practice infringing Article 81(1) of the Treaty.

| 3. | The Advisory Committee agrees with the Commission's views as to the existence of a single and continuous infringement. |
| --- | --- |

3.

The Advisory Committee agrees with the Commission's views as to the existence of a single and continuous infringement.

| 4. | The Advisory Committee agrees with the Commission that the agreement and/or concerted practice has appreciably affected trade between Member States. |
| --- | --- |

4.

The Advisory Committee agrees with the Commission that the agreement and/or concerted practice has appreciably affected trade between Member States.

| 5. | The Advisory Committee agrees with the Commission draft decision as regards the addressees of the decision. |
| --- | --- |

5.

The Advisory Committee agrees with the Commission draft decision as regards the addressees of the decision.

| 6. | The Advisory Committee agrees with the Commission regarding the duration of the infringement. |
| --- | --- |

6.

The Advisory Committee agrees with the Commission regarding the duration of the infringement.

| 7. | The Advisory Committee agrees with the Commission's method for the calculation of the fines, and in particular on:






  — | gravity of the infringement, including differential treatment, |
| --- | --- | --- |

7.

The Advisory Committee agrees with the Commission's method for the calculation of the fines, and in particular on:

—

gravity of the infringement, including differential treatment,

| — | duration of the infringement, |
| --- | --- |

—

duration of the infringement,

| — | attenuating and aggravating circumstances, |
| --- | --- |

—

attenuating and aggravating circumstances,

| — | applicability of the Commission Notice on the non-imposition or reduction of fines (1996 Leniency Notice). |
| --- | --- |

—

applicability of the Commission Notice on the non-imposition or reduction of fines (1996 Leniency Notice).

| 8. | The Advisory Committee recommends the publication of its opinion in the Official Journal of the European Union. |
| --- | --- |

8.

The Advisory Committee recommends the publication of its opinion in the Official Journal of the European Union.

---

| 26.10.2007 | EN | Official Journal of the European Union | C 251/4 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/4

---

Opinion of the Advisory Committee on restrictive practices and dominant positions given at its 399th meeting on 28 November 2005 concerning a draft decision in Case COMP/38354 — Industrial bags

(2007/C 251/05)

| 1. | The Advisory Committee agrees with the European Commission on the basic amount of the fines for the companies concerned. |
| --- | --- |

1.

The Advisory Committee agrees with the European Commission on the basic amount of the fines for the companies concerned.

| 2. | The Advisory Committee agrees with the European Commission on the increase of the basic amount due to aggravating circumstances. |
| --- | --- |

2.

The Advisory Committee agrees with the European Commission on the increase of the basic amount due to aggravating circumstances.

| 3. | The Advisory Committee agrees with the Commission that there is no reduction of the basic amount to be applied due to attenuating circumstances. |
| --- | --- |

3.

The Advisory Committee agrees with the Commission that there is no reduction of the basic amount to be applied due to attenuating circumstances.

| 4. | The Advisory Committee agrees with the Commission on the reduction of the fines based on the 1996 Commission Notice on the non-imposition or reduction of fines in cartel cases. |
| --- | --- |

4.

The Advisory Committee agrees with the Commission on the reduction of the fines based on the 1996 Commission Notice on the non-imposition or reduction of fines in cartel cases.

| 5. | The Advisory Committee agrees with the Commission on the final amounts of the fines. |
| --- | --- |

5.

The Advisory Committee agrees with the Commission on the final amounts of the fines.

| 6. | The Advisory Committee recommends the publication of its opinion in the Official Journal of the European Union. |
| --- | --- |

6.

The Advisory Committee recommends the publication of its opinion in the Official Journal of the European Union.

---

| 26.10.2007 | EN | Official Journal of the European Union | C 251/5 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/5

---

Opinion of the Advisory Committee on concentrations given at its 142nd meeting on 20 July 2006 concerning a draft decision relating to Case COMP/M.3848 — Sea-Invest/EMO-EKOM

(2007/C 251/06)

| 1. | The Advisory Committee agrees with the Commission that the notified operation constitutes a concentration with a Community dimension within the meaning of Article 1(2) and Article 3(1)(b) of the EC Merger Regulation. |
| --- | --- |

1.

The Advisory Committee agrees with the Commission that the notified operation constitutes a concentration with a Community dimension within the meaning of Article 1(2) and Article 3(1)(b) of the EC Merger Regulation.

| 2. | The Advisory Committee agrees with the Commission's definitions of the relevant product markets as stated in the draft decision. |
| --- | --- |

2.

The Advisory Committee agrees with the Commission's definitions of the relevant product markets as stated in the draft decision.

| 3. | The Advisory Committee agrees with the Commission's definitions of the relevant geographic markets as stated in the draft decision. |
| --- | --- |

3.

The Advisory Committee agrees with the Commission's definitions of the relevant geographic markets as stated in the draft decision.

| 4. | The Advisory Committee agrees with the Commission's assessment that the transaction does not lead to any competition concerns due to unilateral effects, strengthening the dominance of Sea-Invest or enabling a price increase by EMO-EKOM, or coordinated effects in terminal services for hinterland traffic for coal and iron ore. |
| --- | --- |

4.

The Advisory Committee agrees with the Commission's assessment that the transaction does not lead to any competition concerns due to unilateral effects, strengthening the dominance of Sea-Invest or enabling a price increase by EMO-EKOM, or coordinated effects in terminal services for hinterland traffic for coal and iron ore.

| 5. | The Advisory Committee agrees with the Commission's assessment that the variations in the joint venture do not lead to any competition concerns due to coordinated effects in accordance with Article 2(4) of the Merger Regulation. |
| --- | --- |

5.

The Advisory Committee agrees with the Commission's assessment that the variations in the joint venture do not lead to any competition concerns due to coordinated effects in accordance with Article 2(4) of the Merger Regulation.

| 6. | The Advisory Committee agrees with the Commission that the concentration as notified does not raise serious doubts as to its compatibility with the common market in accordance with Article 10(2) of the Merger Regulation. |
| --- | --- |

6.

The Advisory Committee agrees with the Commission that the concentration as notified does not raise serious doubts as to its compatibility with the common market in accordance with Article 10(2) of the Merger Regulation.

| 7. | The Advisory Committee agrees with the Commission that the notified concentration should be declared compatible with the Common Market and with the functioning of the EEA Agreement in accordance with Articles 2(2) and 8(1) of the Merger Regulation and Article 57 of the EEA Agreement. |
| --- | --- |

7.

The Advisory Committee agrees with the Commission that the notified concentration should be declared compatible with the Common Market and with the functioning of the EEA Agreement in accordance with Articles 2(2) and 8(1) of the Merger Regulation and Article 57 of the EEA Agreement.

| 8. | The Advisory Committee asks the Commission to take into account all other points raised during the discussion. |
| --- | --- |

8.

The Advisory Committee asks the Commission to take into account all other points raised during the discussion.

---

| 26.10.2007 | EN | Official Journal of the European Union | C 251/6 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/6

---

Final report of the Hearing Officer in Case COMP/M.3848 — Sea-Invest/EMO-EKOM

(Pursuant to Articles 15 and 16 of Commission Decision 2001/462/EC, ECSC of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

(2007/C 251/07)

On 24 February 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (the Merger Regulation) by which the undertaking Sea-Invest N.V. acquires, by way of purchase of shares, joint control of the undertakings Europees Massagoed-Overslagsbedrijf B.V. and Erts- en Kolen Overslagsbedrijf B.V. (EMO-EKOM). Following the transaction EMO-EKOM will be jointly controlled by Sea-Invest N.V., Thyssen-Krupp Veerhaven B.V., H.E.S. Beheer N.V. and Manufrance B.V.

By decision dated 31 March 2006, the Commission found that the transaction raised serious doubts as to its compatibility with the common market and the functioning with the EEA Agreement. Accordingly, the Commission initiated proceedings in accordance with Article 6(1)(c) of the Merger Regulation. Subsequently, on 3 May 2006, the Commission decided to extend the procedure with 20 working days pursuant to Article 10(3)(2) of the Merger Regulation.

On 4 April 2006, Sea-Invest was upon request granted access to certain ‘key documents’ in the Commission's file in accordance with Chapter 7.2 of the Commission Note on ‘Best Practices on the conduct of EC Merger control proceedings’.

Following an in-depth market investigation the relevant Commission services considered that the serious doubts had been removed and that the proposed transaction would not significantly impede effective competition in the common market or a substantial part of it. Accordingly, no Statement of Objections was sent to the parties.

No queries or submission have been made to the Hearing Officer by the parties or any other third party. The case does not call for any particular comments as regards the right to be heard.

Brussels, 26 July 2006.

Serge DURANDE

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| 26.10.2007 | EN | Official Journal of the European Union | C 251/7 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/7

---

Final report of the Hearing Officer in Case COMP/38354 — Industrial bags

(Pursuant to Articles 15 and 16 of Commission Decision 2001/462/EC, ECSC of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

(2007/C 251/08)

The draft decision gives rise to the following observations:

Introduction

The present case arises out of contacts from BPI concerning a cartel relating to plastic industrial bags pursuant to the 1996 Leniency Notice, subsequent inspections carried out by the Commission in June 2002 at the premises of several Community manufacturers of plastic industrial bags and follow up requests for information. The Commission discovered evidence that undertakings had taken part in a potential infringement of Article 81 of the EC Treaty.

Statement of Objections and access to file

A Statement of Objections (‘SO’) was sent on 29 April 2004 to 43 addressees, namely:

| — | Plásticos Españoles SA (‘Aspla’) and Armando Álvarez SA, |
| --- | --- |

—

Plásticos Españoles SA (‘Aspla’) and Armando Álvarez SA,

| — | Combipac BV, Francepac SA, British Polythene Industries plc (BPI), BPI Europe BV, BPI International Limited and BPI International (No 2) Limited (‘BPI’), |
| --- | --- |

—

Combipac BV, Francepac SA, British Polythene Industries plc (BPI), BPI Europe BV, BPI International Limited and BPI International (No 2) Limited (‘BPI’),

| — | Bonar Technical Fabrics NV, Bonar International SA, Bonar International Holdings Ltd and Low & Bonar plc, |
| --- | --- |

—

Bonar Technical Fabrics NV, Bonar International SA, Bonar International Holdings Ltd and Low & Bonar plc,

| — | Fardem Packaging BV, Combattant Holding BV and Kendrion NV (‘Fardem’), |
| --- | --- |

—

Fardem Packaging BV, Combattant Holding BV and Kendrion NV (‘Fardem’),

| — | Trioplast Wittenheim SA, Trioplanex France SA and Trioplast Industrier AB, |
| --- | --- |

—

Trioplast Wittenheim SA, Trioplanex France SA and Trioplast Industrier AB,

| — | FLS Plast A/S and FLS Industries A/S, |
| --- | --- |

—

FLS Plast A/S and FLS Industries A/S,

| — | Cofira-Film and Cofira-Sac (formerly Cofira-Sepso) (‘Cofira’), |
| --- | --- |

—

Cofira-Film and Cofira-Sac (formerly Cofira-Sepso) (‘Cofira’),

| — | Rosenlew Saint Frères Emballage SA, UPM Kymmene Groupe and UPM-Kymmene Oyj, |
| --- | --- |

—

Rosenlew Saint Frères Emballage SA, UPM Kymmene Groupe and UPM-Kymmene Oyj,

| — | Conditionnement et Industrie SA, today known as Bernay Film Plastique (‘Ceisa’), |
| --- | --- |

—

Conditionnement et Industrie SA, today known as Bernay Film Plastique (‘Ceisa’),

| — | Bischof + Klein France, Bischof + Klein GmbH & Co. KG and Bischof + Klein Beteiligungen GmbH (‘B&K’), |
| --- | --- |

—

Bischof + Klein France, Bischof + Klein GmbH & Co. KG and Bischof + Klein Beteiligungen GmbH (‘B&K’),

| — | Nordfolien GmbH (Nordenia Deutschland Steinfeld GmbH) and Nordenia International AG, |
| --- | --- |

—

Nordfolien GmbH (Nordenia Deutschland Steinfeld GmbH) and Nordenia International AG,

| — | RKW AG Rheinische Kunststoffwerke, Renolit AG and JM Gesellschaft für industrielle Beteiligung GmbH & Co. KG (‘RKW’), |
| --- | --- |

—

RKW AG Rheinische Kunststoffwerke, Renolit AG and JM Gesellschaft für industrielle Beteiligung GmbH & Co. KG (‘RKW’),

| — | Sachsa Verpackung GmbH, Gascogne Deutschland GmbH and Groupe Gascogne (‘Sachsa’), |
| --- | --- |

—

Sachsa Verpackung GmbH, Gascogne Deutschland GmbH and Groupe Gascogne (‘Sachsa’),

| — | Koninklijke Verpakkingsindustrie Stempher CV and Stempher BV (‘Stempher’), |
| --- | --- |

—

Koninklijke Verpakkingsindustrie Stempher CV and Stempher BV (‘Stempher’),

| — | Greif France, Greif France Holdings, Greif Coordination Center and Van Leer-Muno BVBA (‘Greif’). |
| --- | --- |

—

Greif France, Greif France Holdings, Greif Coordination Center and Van Leer-Muno BVBA (‘Greif’).

Access to file was provided by means of two CD-ROMs with all the documents contained in the Commission's file received by the parties on 3 or 4 May 2004.

Some documents mentioned in the SO were missing from the CD-ROMs. These documents were made available and, where appropriate, additional time to reply was granted.

Prior to the hearing, RKW requested access to all 1998 and earlier market information submitted by parties in response to requests for information from the Commission, claiming that such information could no longer be considered confidential. Only one company, Stempher, objected to the disclosure of this information. Following correspondence with Stempher on this issue, I adopted a formal decision pursuant to Article 9(3) of the Mandate (1) on 3 November 2004 notifying Stempher that its annual turnover figures, volume and market shares pre 1999 did not contain business secrets and would be disclosed by the Commission. Stempher did not take any further steps at that point so the information in question was made available to all the parties.

The Parties' reply and oral hearing

The initial deadline to reply to the SO was 28 June or 29 June 2004 according to the date of receipt by the parties.

Upon request, limited extensions were granted to Aspla, Cofira, Sachsa, Fardem, Nordenia and Nordfolien, FLS Industries A/S and RKW. Replies were received between 24 June 2004 and 9 July 2004 (i.e. within the time allowed).

Virtually all parties requested an oral hearing or expressed their wish to participate in the hearing. The oral hearing took place on 26, 27 and 28 July 2004. All addressees of the SO, except Ceisa, attended.

At the hearing, Aspla complained that I had refused their request for a postponement of the hearing for reasons of illness of their main legal representative. Given the large number of parties involved, I considered that a last-minute postponement was not a practical option and informed Aspla accordingly. I was satisfied that their rights of defence had not been violated (2).

A number of parties argued both in their written replies and at the hearing that BPI had continued the infringement following submission of the Leniency Application, by having participated in an Internet auction relating to the customer Kali und Salz, and also that BPI had actually instigated and/or led the cartel. RKW, B&K and Nordfolien were asked to furnish details of their accusations in writing within a given time limit after the hearing. BPI had access to extracts relating to the Kali & Salz issue in the replies to the SO of the parties concerned, and to letters from those parties because these statements could jeopardize the possible benefit of its application for immunity under Section B of the 1996 Leniency Notice. However, I did not see any ground to grant access to the replies of the other parties on this issue nor to BPI's arguments in respect of its alleged role as a leader of the cartel as had been further requested.

Subsequently, RKW requested further access to the Commission's file in respect of access to turnover figures of all addressees of the SO for the year 2001. They claimed to have a legitimate interest to be able to verify data that provides the basis for the market shares in the SO since market shares are of significance for the calculation of the basic amount of the fine. I refused their request by letter dated 23 May 2005 on the basis that, in order to protect other parties' legitimate interest in confidentiality, only limited forms of disclosure are accepted and that, in this case, RKW's rights of defence were sufficiently protected by the information already contained in the SO.

Draft final decision

A number of initial addressees of the SO are not addressed in the draft final decision because they have been found to be intermediary holding companies not involved in commercial activities or because they had not participated in the infringement or have been liquidated.

Where the legal entity which took part in the infringement has ceased to exist and has been absorbed by another company, said successor company has been held responsible for the total duration of the infringement committed by the economic unit concerned.

Objections have been dropped in respect of Greif following their written and oral replies to the SO.

Additional representations submitted by one of the addressees concerning its financial situation were given due consideration by the Commission services.

The draft decision submitted to the Commission deals only with objections about which the parties have had the opportunity to state their views.

In the light of the above, I consider that the right of the parties to be heard have been fully respected in this case.

Brussels, 24 November 2005.

Karen WILLIAMS

---

(1)  Decision 2001/462/EC, ECSC.

1

(2)  Case T-86/95, Compagnie Générale Maritime et autres, of 28 February 2002 at paragraph 466.

2

Compagnie Générale Maritime et autres

---

| 26.10.2007 | EN | Official Journal of the European Union | C 251/10 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/10

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2007 to 30 September 2007

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1)
  )

(2007/C 251/09)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | INN
  (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.9.2007 | Gliolan | 5-aminolevulinic acid hydrochloride | Medac Gesellschaft für klinische Spezialpräparate mbH |
| Fehlandtstraße 3 |
| D-20354 Hamburg |

Date of the decision

Name of the medicinal product

INN

(International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

7.9.2007

Gliolan

5-aminolevulinic acid hydrochloride

Medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstraße 3

D-20354 Hamburg

EU/1/07/413/001-003

Powder for oral solution

L01XD04

12.9.2007

17.9.2007

Yondelis

Trabectedin

| Pharma Mar, S.A. |
| --- |
| Avda. de los Reyes 1 |
| Polígono Industrial La Mina |
| E-28770 Colmenar Viejo (Madrid) |

Pharma Mar, S.A.

Avda. de los Reyes 1

Polígono Industrial La Mina

E-28770 Colmenar Viejo (Madrid)

EU/1/07/417/001-002

Powder for concentrate for solution for infusion

L01CX01

20.9.2007

18.9.2007

CELSENTRI

Maraviroc

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/07/418/001-010

Film — coated tablet

J05AX09

20.9.2007

20.9.2007

ECALTA

Anidulafungin

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/07/416/001

Powder and solvent for concentrate for solution for infusion

JO2AX06

24.9.2007

20.9.2007

Cervarix

Human Papilloma Virus-16 and Human Papilloma Virus 18 L1 proteins

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89 |
| B-1330 Rixensart |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89

B-1330 Rixensart

EU/1/07/419/001-009

Suspension for injection

J07BM02

24.9.2007

26.9.2007

Galvus

Vildagliptin

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Orsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Orsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/414/001-017

Tablet

A10BH02

28.9.2007

27.9.2007

Zalasta

Olanzapine

| KRKA, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| SLO-8501 Novo mesto |

KRKA, d.d.

Novo mesto

Šmarješka cesta 6

SLO-8501 Novo mesto

EU/1/07/415/001-031

Tablet

N05AH03

1.10.2007

EU/1/07/415/032-056

Orodispersible tablet

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.9.2007 | Arixtra | Glaxo Group Ltd |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.9.2007

Arixtra

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/206/001-020

5.9.2007

3.9.2007

Quixidar

| Glaxo Group Ltd |
| --- |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/02/207/001-020

5.9.2007

3.9.2007

TRIZIVIR

| Glaxo Group Ltd |
| --- |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/156/002-003

5.9.2007

3.9.2007

Combivir

| Glaxo Group Ltd |
| --- |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/98/058/001-002

5.9.2007

3.9.2007

Mabthera

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City AL7 1TW |
| United Kingdom |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/98/067/001-002

6.9.2007

3.9.2007

Novoseven

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/96/006/001-003

6.9.2007

7.9.2007

RotaTeq

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk |
| F-69007 Lyon |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/348/001-002

11.9.2007

7.9.2007

Evra

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 |
| B-2340 Beerse |

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/02/223/001-003

11.9.2007

7.9.2007

Zavesca

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor |
| 389 Chiswick High Road |
| London W4 4AL |
| United Kingdom |

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High Road

London W4 4AL

United Kingdom

EU/1/02/238/001

11.9.2007

7.9.2007

Ambirix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89 |
| B-1330 Rixensart |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89

B-1330 Rixensart

EU/1/02/224/001-005

11.9.2007

13.9.2007

Tamiflu

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City AL7 1TW |
| United Kingdom |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/02/222/001-002

18.9.2007

13.9.2007

Telzir

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/04/282/001-002

18.9.2007

17.9.2007

Cerezyme

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10 |
| 1411 DD Naarden |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/97/053/001-005

20.9.2007

17.9.2007

Exelon

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/98/066/019-026

20.9.2007

17.9.2007

Mirapexin

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/051/001-012

20.9.2007

17.9.2007

Cialis

| Lilly ICOS Limited |
| --- |
| St Bride's House |
| 10 Salisbury Square |
| London EC4Y 8EH |
| United Kingdom |

Lilly ICOS Limited

St Bride's House

10 Salisbury Square

London EC4Y 8EH

United Kingdom

EU/1/02/237/001-008

28.9.2007

18.9.2007

Actraphane

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/229/001-033

20.9.2007

18.9.2007

Protaphane

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/234/001-017

20.9.2007

18.9.2007

Insulatard

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/233/001-015

20.9.2007

18.9.2007

Xyrem

| UCB Pharma Ltd |
| --- |
| 208 Bath Road |
| Slough |
| Berkshire SL1 3WE |
| United Kingdom |

UCB Pharma Ltd

208 Bath Road

Slough

Berkshire SL1 3WE

United Kingdom

EU/1/05/312/001

20.9.2007

18.9.2007

TOVIAZ

| Schwarz Pharma AG |
| --- |
| Alfred-Nobel Straße 10 |
| D-40789 Monheim |

Schwarz Pharma AG

Alfred-Nobel Straße 10

D-40789 Monheim

EU/1/07/386/001-010

20.9.2007

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

20.9.2007

18.9.2007

Velosulin

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/232/001-003

20.9.2007

18.9.2007

Actrapid

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/230/001-017

20.9.2007

18.9.2007

Mixtard

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

EU/1/02/231/001-037

20.9.2007

19.9.2007

Omnitrope

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

EU/1/06/332/007-009

21.9.2007

19.9.2007

Tamiflu

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City AL7 1TW |
| United Kingdom |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City AL7 1TW

United Kingdom

EU/1/02/222/003-004

21.9.2007

20.9.2007

Somavert

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/02/240/001-004

24.9.2007

25.9.2007

NeuroBloc

| Solstice Neurosciences Ltd |
| --- |
| Fitzwilton House |
| Wilton Place |
| Dublin 2 |
| Ireland |

Solstice Neurosciences Ltd

Fitzwilton House

Wilton Place

Dublin 2

Ireland

EU/1/00/166/001-003

27.9.2007

| Eisai Limited |
| --- |
| 3, Shortlands |
| London W6 8EE |
| United Kingdom |

Eisai Limited

3, Shortlands

London W6 8EE

United Kingdom

27.9.2007

25.9.2007

Prometax

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/98/092/019-026

27.9.2007

25.9.2007

Sifrol

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/050/001-012

27.9.2007

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.9.2007 | Oxyblobin | Biopure Netherlands B.V. |
| Parnassustoren |
| Locatellikade 1 |
| 1076 AZ Amsterdam |
| Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.9.2007

Oxyblobin

Biopure Netherlands B.V.

Parnassustoren

Locatellikade 1

1076 AZ Amsterdam

Nederland

EU/2/99/015/001

5.9.2007

4.9.2007

Econor

| Novartis Animal Health Austria GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

Novartis Animal Health Austria GmbH

Biochemiestraße 10

A-6250 Kundl

EU/2/98/010/004-006

EU/2/98/010/017-018

EU/2/98/010/021-024

6.9.2007

7.9.2007

Cortavance

| VIRBAC S.A. |
| --- |
| 1ère Avenue 2065 m L.I.D. |
| F-06516 Carros |

VIRBAC S.A.

1ère Avenue 2065 m L.I.D.

F-06516 Carros

EU/2/06/069/001

11.9.2007

7.9.2007

Meloxidyl

| CEVA SANTE ANIMALE |
| --- |
| Z.I. la Ballastière |
| F-33500 Libourne |

CEVA SANTE ANIMALE

Z.I. la Ballastière

F-33500 Libourne

EU/2/06/070/001-003

11.9.2007

25.9.2007

Nobivac Bb

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/02/034/001

27.9.2007

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus |
| Canary Wharf |
| London E14 4HB |
| United Kingdom |

The European Medicines Agency

7, Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 26.10.2007 | EN | Official Journal of the European Union | C 251/16 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/16

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2007 to 30 September 2007

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2))

(2007/C 251/10)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 3.9.2007 | Bicalutamide | See Annex I | See Annex I | 5.9.2007 |
| 7.9.2007 | Gliolan | Medac Gesellschaft für klinische Spezialpräparate mbH |
| Fehlandtstraße 3 |
| D-20354 Hamburg |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

3.9.2007

Bicalutamide

See Annex I

See Annex I

5.9.2007

7.9.2007

Gliolan

Medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstraße 3

D-20354 Hamburg

This Decision is addressed to the Member States

11.9.2007

7.9.2007

Piroxicam

See Annex II

See Annex II

11.9.2007

18.9.2007

Lansoprazole

See Annex III

See Annex III

27.9.2007

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Marketing Authorisation Holders

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Astra Zeneca Österreich GmbH |
| Schwarzenbergplatz 7 |
| A-1037 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Astra Zeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Casodex

150 mg

Film-coated tablet

Oral use

Austria

| Genericon Pharma Ges.m.b.H. |
| --- |
| Hafnerstraße 211 |
| A-8054 Graz |

Genericon Pharma Ges.m.b.H.

Hafnerstraße 211

A-8054 Graz

Bicalutamid „Genericon“

150 mg

Film-coated tablet

Oral use

Austria

| Genericon Pharma Ges.m.b.H. |
| --- |
| Hafnerstraße 211 |
| A-8054 Graz |

Genericon Pharma Ges.m.b.H.

Hafnerstraße 211

A-8054 Graz

Bicalutanorm „Genericon“

150 mg

Film-coated tablet

Oral use

Austria

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer Gasse 3 |
| A-1140 Wien |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer Gasse 3

A-1140 Wien

Bicalutamid-ratiopharm

150 mg

Film-coated tablet

Oral use

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Casodex

150 mg

Film-coated tablet

Oral use

Bulgaria

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Czech Republic

| AstraZeneca UK Limited |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Czech Republic

| Ingers Industrial Solutions s.r.o. BRNO |
| --- |
| Jeneweinova 51a |
| CZ-617 00 Brno |

Ingers Industrial Solutions s.r.o. BRNO

Jeneweinova 51a

CZ-617 00 Brno

Bicaluplex

150 mg

Film-coated tablet

Oral use

Cyprus

| AstraZeneca UK Limited |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund

Casodex

150 mg

Film-coated tablet

Oral use

Greece

| AstraZeneca SA |
| --- |
| 4 Theotocopoulou & Astronauton |
| GR-151 25 Marousi-Athens |

AstraZeneca SA

4 Theotocopoulou & Astronauton

GR-151 25 Marousi-Athens

Casodex

150 mg

Film-coated tablet

Oral use

Greece

| Dermos Meπε-pharmaceitica |
| --- |
| 25 Paraschou str. |
| Athens |

Dermos Meπε-pharmaceitica

25 Paraschou str.

Athens

Verodex

150 mg

Film-coated tablet

Oral use

Greece

| Alvia SA |
| --- |
| 18th klm Athens-Marathon Ave |
| GR-153 44 Pallini Attiki |

Alvia SA

18th klm Athens-Marathon Ave

GR-153 44 Pallini Attiki

Bicalut

150 mg

Film-coated tablet

Oral use

Greece

| Genepharm SA |
| --- |
| 18th klm Marathon Ave |
| GR-153 44 Pallini Attiki |

Genepharm SA

18th klm Marathon Ave

GR-153 44 Pallini Attiki

Bicamide/Genepharm

150 mg

Film-coated tablet

Oral use

Estonia

| AstraZeneca UK Limited |
| --- |
| Stanhope Gate 15 |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

Stanhope Gate 15

London W1K 1LN

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Casodex

150 mg

Film-coated tablet

Oral use

Finland

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Lukasenomid

150 mg

Film-coated tablet

Oral use

Finland

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Bicalutamid CT-Arzneimittel

150 mg

Film-coated tablet

Oral use

Finland

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Bicalutamid Ratiopharm

150 mg

Film-coated tablet

Oral use

Finland

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Bicalutamid Ribosepharm

150 mg

Film-coated tablet

Oral use

Finland

| Avansor Pharma Oy |
| --- |
| Tekniikantie 14 |
| FI-02150 Espoo |

Avansor Pharma Oy

Tekniikantie 14

FI-02150 Espoo

Bicavan

150 mg

Film-coated tablet

Oral use

Finland

| Synthon BV |
| --- |
| Microweg 22 |
| 6545 GN Nijmegen |
| Nederland |

Synthon BV

Microweg 22

6545 GN Nijmegen

Nederland

Bikalutamidi Synthon

150 mg

Film-coated tablet

Oral use

Finland

| Alternova Oy Ab |
| --- |
| Rajatorpantie 41 C |
| FI-01640 Vantaa |

Alternova Oy Ab

Rajatorpantie 41 C

FI-01640 Vantaa

Bicalutamid Alternova

150 mg

Film-coated tablet

Oral use

Finland

| Peseri Trading Limited |
| --- |
| El Greco House |
| 20 Queen Frederiks Street |
| Office 301 |
| CY-1066 Nicosia |

Peseri Trading Limited

El Greco House

20 Queen Frederiks Street

Office 301

CY-1066 Nicosia

Alidex

150 mg

Film-coated tablet

Oral use

Finland

| Peseri Trading Limited |
| --- |
| El Greco House |
| 20 Queen Frederiks Street |
| Office 301 |
| CY-1066 Nicosia |

Peseri Trading Limited

El Greco House

20 Queen Frederiks Street

Office 301

CY-1066 Nicosia

Bicadex

150 mg

Film-coated tablet

Oral use

Finland

| Orion Corporation |
| --- |
| Orionintie 1, PO Box 65 |
| FI-02101 Espoo |

Orion Corporation

Orionintie 1, PO Box 65

FI-02101 Espoo

Bicalutamid Orion

150 mg

Film-coated tablet

Oral use

Finland

| Peseri Trading Limited |
| --- |
| El Greco House |
| 20 Queen Frederiks Street |
| Office 301 |
| CY-1066 Nicosia |

Peseri Trading Limited

El Greco House

20 Queen Frederiks Street

Office 301

CY-1066 Nicosia

Bicalutamide Peseri

150 mg

Film-coated tablet

Oral use

Finland

| Tad Pharma GmbH |
| --- |
| Heinz-Lohmann-Straße 5 |
| D-27472 Cuxhaven |

Tad Pharma GmbH

Heinz-Lohmann-Straße 5

D-27472 Cuxhaven

Bicatad

150 mg

Film-coated tablet

Oral use

Finland

| Peseri Trading Limited |
| --- |
| El Greco House |
| 20 Queen Frederiks Street |
| Office 301 |
| CY-1066 Nicosia |

Peseri Trading Limited

El Greco House

20 Queen Frederiks Street

Office 301

CY-1066 Nicosia

Biclad

150 mg

Film-coated tablet

Oral use

Finland

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstraße 28 |
| D-20097 Hamburg |

Helm Pharmaceuticals GmbH

Nordkanalstraße 28

D-20097 Hamburg

Duralutamide

150 mg

Film-coated tablet

Oral use

Finland

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstraße 28 |
| D-20097 Hamburg |

Helm Pharmaceuticals GmbH

Nordkanalstraße 28

D-20097 Hamburg

Grelutamide

150 mg

Film-coated tablet

Oral use

Finland

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstraße 28 |
| D-20097 Hamburg |

Helm Pharmaceuticals GmbH

Nordkanalstraße 28

D-20097 Hamburg

Henlutamide

150 mg

Film-coated tablet

Oral use

Finland

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstraße 28 |
| D-20097 Hamburg |

Helm Pharmaceuticals GmbH

Nordkanalstraße 28

D-20097 Hamburg

Inatamide

150 mg

Film-coated tablet

Oral use

Finland

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstraße 28 |
| D-20097 Hamburg |

Helm Pharmaceuticals GmbH

Nordkanalstraße 28

D-20097 Hamburg

Konlutamide

150 mg

Film-coated tablet

Oral use

Finland

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstraße 28 |
| D-20097 Hamburg |

Helm Pharmaceuticals GmbH

Nordkanalstraße 28

D-20097 Hamburg

Saputamide

150 mg

Film-coated tablet

Oral use

Finland

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstraße 28 |
| D-20097 Hamburg |

Helm Pharmaceuticals GmbH

Nordkanalstraße 28

D-20097 Hamburg

Skylutamide

150 mg

Film-coated tablet

Oral use

Finland

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstraße 28 |
| D-20097 Hamburg |

Helm Pharmaceuticals GmbH

Nordkanalstraße 28

D-20097 Hamburg

Timutamide

150 mg

Film-coated tablet

Oral use

Finland

| Peseri Trading Limited |
| --- |
| El Greco House |
| 20 Queen Frederiks Street |
| Office 301 |
| CY-1066 Nicosia |

Peseri Trading Limited

El Greco House

20 Queen Frederiks Street

Office 301

CY-1066 Nicosia

Lutamide

150 mg

Film-coated tablet

Oral use

France

| AstraZeneca |
| --- |
| 1, place Renault |
| F-92844 Rueil-Malmaison Cedex |

AstraZeneca

1, place Renault

F-92844 Rueil-Malmaison Cedex

Casodex

150 mg

Film-coated tablet

Oral use

Hungary

| Pharmaconsult Kft. |
| --- |
| Ráskay Lea u. 44. |
| H-1141 Budapest |

Pharmaconsult Kft.

Ráskay Lea u. 44.

H-1141 Budapest

Bilutamid

150 mg

Film-coated tablet

Oral use

Hungary

| AstraZeneca KFt. |
| --- |
| Park u. 3. |
| H-2045 Törökbálint |

AstraZeneca KFt.

Park u. 3.

H-2045 Törökbálint

Casodex

150 mg

Film-coated tablet

Oral use

Iceland

| AstraZeneca UK Limited |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Italy

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via F. Sforza |
| I-20080 Basiglio (MI) |

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

I-20080 Basiglio (MI)

Casodex

150 mg

Film-coated tablet

Oral use

Lithuania

| AstraZeneca UK Limited |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Luxembourg

| NV AstraZeneca SA |
| --- |
| 110 rue E. Van Ophem |
| B-1180 Bruxelles |

NV AstraZeneca SA

110 rue E. Van Ophem

B-1180 Bruxelles

Casodex

150 mg

Film-coated tablet

Oral use

Latvia

| AstraZeneca UK Limited |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Norway

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| N-0319 Oslo |

AstraZeneca AS

Boks 200 Vinderen

N-0319 Oslo

Casodex

150 mg

Film-coated tablet

Oral use

Poland

| AstraZeneca UK Limited |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| P-2745-663 Barcarena |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

P-2745-663 Barcarena

Casodex

150 mg

Film-coated tablet

Oral use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura |
| Edifício 4 Quinta da Beloura |
| P-2710-444 Sintra |

Generis Farmacêutica, S.A.

Office Park da Beloura

Edifício 4 Quinta da Beloura

P-2710-444 Sintra

Bicalutamida Generis

150 mg

Film-coated tablet

Oral use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura |
| Edifício 4 Quinta da Beloura |
| P-2710-444 Sintra |

Generis Farmacêutica, S.A.

Office Park da Beloura

Edifício 4 Quinta da Beloura

P-2710-444 Sintra

Bicalutamida Prostec

150 mg

Film-coated tablet

Oral use

Portugal

| Farma-APS, Produtos Farmacêuticos, S.A. |
| --- |
| Rua João de Deus, 19 |
| Venda Nova |
| P-2700-487 Amadora |

Farma-APS, Produtos Farmacêuticos, S.A.

Rua João de Deus, 19

Venda Nova

P-2700-487 Amadora

Bicalutamida Etsi

150 mg

Film-coated tablet

Oral use

Romania

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Slovakia

| AstraZeneca UK Limited |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Slovenia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Sweden

| AstraZeneca AB |
| --- |
| Västra Mälarehamnen 9 |
| S-151 85 Södertälje |

AstraZeneca AB

Västra Mälarehamnen 9

S-151 85 Södertälje

Casodex

150 mg

Film-coated tablet

Oral use

United Kingdom

| AstraZeneca UK Limited |
| --- |
| Horizon Place |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

Horizon Place

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

United Kingdom

| AstraZeneca UK Limited |
| --- |
| Horizon Place |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

Horizon Place

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Bicalutamide

150 mg

Film-coated tablet

Oral use

Applicants

| Member State | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Dr. Robert Heinz & Partner GmbH |
| Kaiserstraße 84/9 |
| A-1070 Wien |

Member State

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Dr. Robert Heinz & Partner GmbH

Kaiserstraße 84/9

A-1070 Wien

Bicaludex

150 mg

Film-coated tablet

Oral use

Austria

| Dermapharm GmbH |
| --- |
| Türkenstraße 25/12 |
| A-1090 Wien |

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Bicalutamid „Dermapharm“

150 mg

Film-coated tablet

Oral use

Czech Republic

| Super Vision s.r.o. |
| --- |
| Praha |
| Krohova 60 |
| CZ-160 00 Praha 6 |

Super Vision s.r.o.

Praha

Krohova 60

CZ-160 00 Praha 6

Calumid

150 mg

Film-coated tablet

Oral use

Czech Republic

| Genthon BV |
| --- |
| Microweg 22 |
| 6545 Nijmegen |
| Nederland |

Genthon BV

Microweg 22

6545 Nijmegen

Nederland

Bicalutamidum Genthon

150 mg

Film-coated tablet

Oral use

Denmark

| Jacobsen Pharma A/S |
| --- |
| Vemmingbund Strandvej 111 |
| DK-6310 Broager |

Jacobsen Pharma A/S

Vemmingbund Strandvej 111

DK-6310 Broager

Beluclas

150 mg

Film-coated tablet

Oral use

Denmark

| Jacobsen Pharma A/S |
| --- |
| Vemmingbund Strandvej 111 |
| DK-6310 Broager |

Jacobsen Pharma A/S

Vemmingbund Strandvej 111

DK-6310 Broager

Crilame

150 mg

Film-coated tablet

Oral use

Denmark

| Jacobsen Pharma A/S |
| --- |
| Vemmingbund Strandvej 111 |
| DK-6310 Broager |

Jacobsen Pharma A/S

Vemmingbund Strandvej 111

DK-6310 Broager

Helmalut

150 mg

Film-coated tablet

Oral use

Denmark

| Jacobsen Pharma A/S |
| --- |
| Vemmingbund Strandvej 111 |
| DK-6310 Broager |

Jacobsen Pharma A/S

Vemmingbund Strandvej 111

DK-6310 Broager

Pecamid

150 mg

Film-coated tablet

Oral use

Germany

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Bicalutamid Hexal

150 mg

Film-coated tablet

Oral use

Germany

| mibe GmbH Arzneimittel |
| --- |
| Münchener Straße 15 |
| D-06796 Brehna |

mibe GmbH Arzneimittel

Münchener Straße 15

D-06796 Brehna

Bicalutamid mibe

150 mg

Film-coated tablet

Oral use

Greece

| Pharmanel Pharmaceutical AE |
| --- |
| Marathonos 106 |
| GR-15344 Gerakas |

Pharmanel Pharmaceutical AE

Marathonos 106

GR-15344 Gerakas

Bicatin

150 mg

Film-coated tablet

Oral use

Greece

| Demo Abee |
| --- |
| 21st Km National Road |
| GR-14565 Athens-Lamia |

Demo Abee

21st Km National Road

GR-14565 Athens-Lamia

Zarmol

150 mg

Film-coated tablet

Oral use

Estonia

| Billev Pharma ApS |
| --- |
| Elmegårdsvej 1A, Torslev |
| DK-3630 Jægerspris |

Billev Pharma ApS

Elmegårdsvej 1A, Torslev

DK-3630 Jægerspris

Calumid

150 mg

Film-coated tablet

Oral use

Finland

| Peseri Trading Limited |
| --- |
| El Greco House |
| 20 Queen Frederiks Street |
| Office 301 |
| CY-1066 Nicosia |

Peseri Trading Limited

El Greco House

20 Queen Frederiks Street

Office 301

CY-1066 Nicosia

Bicalutamide Relon Chem

150 mg

Film-coated tablet

Oral use

Finland

| Copyfarm A/S |
| --- |
| Energivej 15 |
| DK-5260 Odense S |

Copyfarm A/S

Energivej 15

DK-5260 Odense S

Bicalutamid Copyfarm

150 mg

Film-coated tablet

Oral use

Finland

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstraße 28 |
| D-20097 Hamburg |

Helm Pharmaceuticals GmbH

Nordkanalstraße 28

D-20097 Hamburg

Krislutamide

150 mg

Film-coated tablet

Oral use

France

| Wyvern Medical |
| --- |
| Sterling House |
| 3A New Street |
| Ledbury HR8 2DX |
| Herefordshire |
| United Kingdom |

Wyvern Medical

Sterling House

3A New Street

Ledbury HR8 2DX

Herefordshire

United Kingdom

Bicalutamide Wyvern Medical

150 mg

Film-coated tablet

Oral use

France

| Delbert |
| --- |
| 56, Quai A. Le gallo |
| F-92100 Boulogne Billancourt |

Delbert

56, Quai A. Le gallo

F-92100 Boulogne Billancourt

Bicadel

150 mg

Film-coated tablet

Oral use

France

| BioOrganics |
| --- |
| PO Box 7071 |
| 6503 GN Nijmegen |
| Nederland |

BioOrganics

PO Box 7071

6503 GN Nijmegen

Nederland

Bicalutamide BioOrganics

150 mg

Film-coated tablet

Oral use

France

| Sandoz S.A.S |
| --- |
| 49, ave. Georges Pompidou |
| F-92300 Levallois-Perret |

Sandoz S.A.S

49, ave. Georges Pompidou

F-92300 Levallois-Perret

Bicalutamide G GAM

150 mg

Film-coated tablet

Oral use

Hungary

| Medico Uno Pharma Kft. |
| --- |
| Viadukt utca 12. |
| H-2051 Biatorbágy |

Medico Uno Pharma Kft.

Viadukt utca 12.

H-2051 Biatorbágy

Bicalutamide-MedicoUno

150 mg

Film-coated tablet

Oral use

Hungary

| Richter Gedeon Rt. |
| --- |
| Gyömrői út 19-21. |
| H-1103 Budapest |

Richter Gedeon Rt.

Gyömrői út 19-21.

H-1103 Budapest

Calumid

150 mg

Film-coated tablet

Oral use

Poland

| Diammed GmbH |
| --- |
| Kaiser-Wilhelm-Ring 4-6 |
| D-48145 Munster |

Diammed GmbH

Kaiser-Wilhelm-Ring 4-6

D-48145 Munster

Calumid

150 mg

Film-coated tablet

Oral use

Slovakia

| Vale Pharmaceuticals Limited Tipperary |
| --- |
| Jervis House |
| Parnell St |
| Clonmel, Co. |
| Ireland |

Vale Pharmaceuticals Limited Tipperary

Jervis House

Parnell St

Clonmel, Co.

Ireland

Calumid

150 mg

Film-coated tablet

Oral use

Slovakia

| Archie Samuel s.r.o. |
| --- |
| Nivky 33 |
| CZ-628 00 Brno |

Archie Samuel s.r.o.

Nivky 33

CZ-628 00 Brno

Bicaluplex

150 mg

Film-coated tablet

Oral use

United Kingdom

| Tenlec Pharma Limited |
| --- |
| Broadlands |
| Amberstone |
| Hailsham |
| East Sussex BN27 1PQ |
| United Kingdom |

Tenlec Pharma Limited

Broadlands

Amberstone

Hailsham

East Sussex BN27 1PQ

United Kingdom

Bicasel

150 mg

Film-coated tablet

Oral use

United Kingdom

| Tenlec Pharma Limited |
| --- |
| Broadlands |
| Amberstone |
| Hailsham |
| East Sussex BN27 1PQ |
| United Kingdom |

Tenlec Pharma Limited

Broadlands

Amberstone

Hailsham

East Sussex BN27 1PQ

United Kingdom

Bicamale

150 mg

Film-coated tablet

Oral use

United Kingdom

| MPX International Limited |
| --- |
| 127 Shirland Road |
| London W9 2EP |
| United Kingdom |

MPX International Limited

127 Shirland Road

London W9 2EP

United Kingdom

Bicalutamide

150 mg

Film-coated tablet

Oral use

United Kingdom

| Kiron Pharmaceutica BV |
| --- |
| Groesbeekseweg 11 |
| 6524 CK Nijmegen |
| Nederland |

Kiron Pharmaceutica BV

Groesbeekseweg 11

6524 CK Nijmegen

Nederland

Bicalutamide Kiron

150 mg

Film-coated tablet

Oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Gesmbh |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Pfizer Corporation Austria Gesmbh

Floridsdorfer Hauptstraße 1

A-1210 Wien

Felden — Gel

Gel

Cutaneous use

Austria

| Pfizer Corporation Austria Gesmbh |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Pfizer Corporation Austria Gesmbh

Floridsdorfer Hauptstraße 1

A-1210 Wien

Felden 20 mg — Ampullen

20 mg

Ampoule

Parenteral use

Austria

| Pfizer Corporation Austria Gesmbh |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Pfizer Corporation Austria Gesmbh

Floridsdorfer Hauptstraße 1

A-1210 Wien

Felden 20 mg — KapseLN

10 mg

Capsule

Oral use

Austria

| Pfizer Corporation Austria Gesmbh |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Pfizer Corporation Austria Gesmbh

Floridsdorfer Hauptstraße 1

A-1210 Wien

Felden 20 mg — KapseLN

20 mg

Capsule

Oral use

Austria

| Pfizer Corporation Austria Gesmbh |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Pfizer Corporation Austria Gesmbh

Floridsdorfer Hauptstraße 1

A-1210 Wien

Felden 20 mg — Lösbare Tabletten

20 mg

Tablet

Oral use

Austria

| Pfizer Corporation Austria Gesmbh |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |

Pfizer Corporation Austria Gesmbh

Floridsdorfer Hauptstraße 1

A-1210 Wien

Felden Quick — Solve 20 mg — Lyotabletten

20 mg

Tablet

Oral use

Austria

| Ratiopharm Arzneimittel Vertriebs-Gmbh |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

Ratiopharm Arzneimittel Vertriebs-Gmbh

Albert-Schweitzer-Gasse 3

A-1140 Wien

Pirocam 20 mg — Ampullen

20 mg

Ampoule

Parenteral use

Austria

| Ratiopharm Arzneimittel Vertriebs-Gmbh |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

Ratiopharm Arzneimittel Vertriebs-Gmbh

Albert-Schweitzer-Gasse 3

A-1140 Wien

Pirocam 20 mg — Tabletten

20 mg

Tablet

Oral use

Austria

| Ratiopharm Arzneimittel Vertriebs-Gmbh |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

Ratiopharm Arzneimittel Vertriebs-Gmbh

Albert-Schweitzer-Gasse 3

A-1140 Wien

Pirocam 20 mg — Zäpfchen

20 mg

Suppository

Rectal use

Austria

| Hexal Pharma GmbH |
| --- |
| Carlbergergasse 44 |
| A-1235 Wien |

Hexal Pharma GmbH

Carlbergergasse 44

A-1235 Wien

Pirorheum 10 mg — Tabletten

10 mg

Tablet

Oral use

Austria

| Hexal Pharma GmbH |
| --- |
| Carlbergergasse 44 |
| A-1235 Wien |

Hexal Pharma GmbH

Carlbergergasse 44

A-1235 Wien

Pirorheum 20 mg — Tabletten

20 mg

Tablet

Oral use

Austria

| Ci Pharma Arzneimittel Handelsgesmbh |
| --- |
| Thimiggasse 25 |
| A-1180 Wien |

Ci Pharma Arzneimittel Handelsgesmbh

Thimiggasse 25

A-1180 Wien

Piroxicam „Ci Pharma“ 20 mg — Brausepulver

20 mg

Effervescent powder

Oral use

Austria

| Stada Arzneimittel GmbH |
| --- |
| Heiligenstädterstraße 52/2/8 |
| A-1190 Wien |

Stada Arzneimittel GmbH

Heiligenstädterstraße 52/2/8

A-1190 Wien

Piroxistad 10 mg Tabs — Lösbare Tabletten

10 mg

Tablet

Oral use

Austria

| Stada Arzneimittel GmbH. |
| --- |
| Heiligenstädterstraße 52/2/8 |
| A-1190 Wien |

Stada Arzneimittel GmbH.

Heiligenstädterstraße 52/2/8

A-1190 Wien

Piroxistad 20 mg Tabs — Lösbare Tabletten

20 mg

Tablet

Oral use

Austria

| Amat Pharma Trading GmbH |
| --- |
| Walfischgasse 6/2/1/3 |
| A-1010 Wien |

Amat Pharma Trading GmbH

Walfischgasse 6/2/1/3

A-1010 Wien

Pirox 10 mg — KapseLN

10 mg

Capsule

Oral use

Austria

| Amat Pharma Trading GmbH |
| --- |
| Walfischgasse 6/2/1/3 |
| A-1010 Wien |

Amat Pharma Trading GmbH

Walfischgasse 6/2/1/3

A-1010 Wien

Pirox 20 mg — KapseLN

20 mg

Capsule

Oral use

Austria

| Amat Pharma Trading GmbH |
| --- |
| Walfischgasse 6/2/1/3 |
| A-1010 Wien |

Amat Pharma Trading GmbH

Walfischgasse 6/2/1/3

A-1010 Wien

Pirox 0,2 % — Orale Suspension

2 mg/ml

Oral suspension

Oral use

Austria

| Boehringer Ingelheim Austria GmbH |
| --- |
| Dr. Boehringer-Gasse 5-11 |
| A-1121 Wien |

Boehringer Ingelheim Austria GmbH

Dr. Boehringer-Gasse 5-11

A-1121 Wien

Tonimed — Gel

Gel

Topical use

Austria

| Torrex-Chiesi Pharma GmbH |
| --- |
| Gonzagagasse 16/16 |
| A-1010 Wien |

Torrex-Chiesi Pharma GmbH

Gonzagagasse 16/16

A-1010 Wien

Brexin 20 mg — Tabletten

20 mg

Tablets

Oral use

Austria

| Torrex-Chiesi Pharma GmbH |
| --- |
| Gonzagagasse 16/16 |
| A-1010 Wien |

Torrex-Chiesi Pharma GmbH

Gonzagagasse 16/16

A-1010 Wien

Brexin-Pulver

20 mg

Oral powder

Oral use

Belgium

| 3ddd Pharma N.N. |
| --- |
| Diestersteenweg 349 |
| B-3510 Hasselt |

3ddd Pharma N.N.

Diestersteenweg 349

B-3510 Hasselt

Piromed

0,50 %

Gel

Transdermal use

Belgium

| 3ddd Pharma N.N. |
| --- |
| Diestersteenweg 349 |
| B-3510 Hasselt |

3ddd Pharma N.N.

Diestersteenweg 349

B-3510 Hasselt

Piromed Dispers

20 mg

Tablet

Oral use

Belgium

| Aktuapharma N.V. |
| --- |
| Ambachtenlaan 13e |
| B-3001 Leuven |

Aktuapharma N.V.

Ambachtenlaan 13e

B-3001 Leuven

Brexine

20 mg

Tablet

Oral use

Belgium

| Aktuapharma N.V. |
| --- |
| Ambachtenlaan 13e |
| B-3001 Leuven |

Aktuapharma N.V.

Ambachtenlaan 13e

B-3001 Leuven

Brexine

20 mg

Tablet

Oral use

Belgium

| Aktuapharma N.V. |
| --- |
| Ambachtenlaan 13e |
| B-3001 Leuven |

Aktuapharma N.V.

Ambachtenlaan 13e

B-3001 Leuven

Feldene Dispersal

20 mg

Tablet

Oral use

Belgium

| Aktuapharma N.V. |
| --- |
| Ambachtenlaan 13e |
| B-3001 Leuven |

Aktuapharma N.V.

Ambachtenlaan 13e

B-3001 Leuven

Feldene

20 mg

Capsule

Oral use

Belgium

| Aktuapharma N.V. |
| --- |
| Ambachtenlaan 13e |
| B-3001 Leuven |

Aktuapharma N.V.

Ambachtenlaan 13e

B-3001 Leuven

Feldene Im

20 mg/ml

Solution for injection

Intramuscular use

Belgium

| Aktuapharma N.V. |
| --- |
| Ambachtenlaan 13e |
| B-3001 Leuven |

Aktuapharma N.V.

Ambachtenlaan 13e

B-3001 Leuven

Feldene Lyotabs

20 mg

Lyophilisat

Oral use

Belgium

| Aktuapharma N.V. |
| --- |
| Ambachtenlaan 13e |
| B-3001 Leuven |

Aktuapharma N.V.

Ambachtenlaan 13e

B-3001 Leuven

Piroxicam Eg

20 mg

Capsule

Oral use

Belgium

| Bexal S.P.R.L. |
| --- |
| Avenue Jules Bordet 168 |
| B-1140 Brussel |

Bexal S.P.R.L.

Avenue Jules Bordet 168

B-1140 Brussel

Piroxicam Bexal

10 mg

Tablet

Oral use

Belgium

| Bexal S.P.R.L. |
| --- |
| Avenue Jules Bordet 168 |
| B-1140 Brussel |

Bexal S.P.R.L.

Avenue Jules Bordet 168

B-1140 Brussel

Piroxicam Bexal

20 mg

Tablet

Oral use

Belgium

| Docpharma N.V. |
| --- |
| Ambachtenlaan |
| B-3001 Heverlee |

Docpharma N.V.

Ambachtenlaan

B-3001 Heverlee

Dociproxi Dispers Ex Piroxicam

20 mg

Dispersible tablet

Oral use

Belgium

| Ethimed N.V. |
| --- |
| Leuvensestraat 28 Bus 2 |
| B-1800 Vilvoorde |

Ethimed N.V.

Leuvensestraat 28 Bus 2

B-1800 Vilvoorde

Piroxymed

20 mg

Dispersible tablet

Oral use

Belgium

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade 22 |
| B-1020 Brussel |

Eurogenerics N.V.

Heizel Esplanade 22

B-1020 Brussel

Piroxicam Eg

10 mg

Capsule

Oral use

Belgium

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade 22 |
| B-1020 Brussel |

Eurogenerics N.V.

Heizel Esplanade 22

B-1020 Brussel

Piroxicam Eg

20 mg

Capsule

Oral use

Belgium

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade 22 |
| B-1020 Brussel |

Eurogenerics N.V.

Heizel Esplanade 22

B-1020 Brussel

Piroxicam Eg

20 mg

Dispersible tablet

Oral use

Belgium

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade 22 |
| B-1020 Brussel |

Eurogenerics N.V.

Heizel Esplanade 22

B-1020 Brussel

Piroxicam Eg

20 mg/ml

Solution for injection

Intramuscular use

Belgium

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade 22 |
| B-1020 Brussel |

Eurogenerics N.V.

Heizel Esplanade 22

B-1020 Brussel

Piroxicam Generix

20 mg

Dispersible tablet

Oral use

Belgium

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade 22 |
| B-1020 Brussel |

Eurogenerics N.V.

Heizel Esplanade 22

B-1020 Brussel

Piroxicam Generix

20 mg

Capsule

Oral use

Belgium

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade 22 |
| B-1020 Brussel |

Eurogenerics N.V.

Heizel Esplanade 22

B-1020 Brussel

Piroxicam-Ratiopharm

20 mg

Solution for injection

Intramuscular use

Belgium

| Eurogenerics N.V. |
| --- |
| Heizel Esplanade 22 |
| B-1020 Brussel |

Eurogenerics N.V.

Heizel Esplanade 22

B-1020 Brussel

Piroxicamstada

20 mg

Capsule

Oral use

Belgium

| Euro-Medic N.V. |
| --- |
| Astridlaan 20 |
| B-8620 Nieuwpoort |

Euro-Medic N.V.

Astridlaan 20

B-8620 Nieuwpoort

Brexine

20 mg

Tablet

Oral use

Belgium

| Euro-Medic N.V. |
| --- |
| Astridlaan 20 |
| B-8620 Nieuwpoort |

Euro-Medic N.V.

Astridlaan 20

B-8620 Nieuwpoort

Feldene Lyotabs

20 mg

Tablet

Oral use

Belgium

| Kela Laboratoria N.V. |
| --- |
| Sint Lenaartseweg 48/4 |
| B-2320 Hoogstraten |

Kela Laboratoria N.V.

Sint Lenaartseweg 48/4

B-2320 Hoogstraten

Piroxicam Kela Ex Revalat

20 mg

Dispersible tablet

Oral use

Belgium

| Laboratoires S.M.B S. S.A. |
| --- |
| Rue De La Pastorale 16/28 |
| B-1080 Brussel |

Laboratoires S.M.B S. S.A.

Rue De La Pastorale 16/28

B-1080 Brussel

Solicam

10 mg

Capsule

Oral use

Belgium

| Laboratoires S.M.B S. S.A. |
| --- |
| Rue De La Pastorale 16/28 |
| B-1080 Brussel |

Laboratoires S.M.B S. S.A.

Rue De La Pastorale 16/28

B-1080 Brussel

Solicam

20 mg

Capsule

Oral use

Belgium

| Merck N.V. |
| --- |
| Brusselesteenweg 288 |
| B-3090 Overijse |

Merck N.V.

Brusselesteenweg 288

B-3090 Overijse

Merck-Piroxicam

20 mg

Capsule

Oral use

Belgium

| Nycomed Belgium N.V. |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Belgium N.V.

Gentsesteenweg 615

B-1080 Brussel

Brexine

10 mg

Tablet

Oral use

Belgium

| Nycomed Belgium N.V. |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Belgium N.V.

Gentsesteenweg 615

B-1080 Brussel

Brexine-Dryfiz Ex Piroxidex

20 mg

Tablet

Oral use

Belgium

| Nycomed Belgium N.V. |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Belgium N.V.

Gentsesteenweg 615

B-1080 Brussel

Brexine

20 mg

Granules

Oral use

Belgium

| Nycomed Belgium N.V. |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Belgium N.V.

Gentsesteenweg 615

B-1080 Brussel

Brexine

20 mg

Tablet

Oral use

Belgium

| Nycomed Belgium N.V. |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Belgium N.V.

Gentsesteenweg 615

B-1080 Brussel

Piroxidex

20 mg

Dispersible tablet

Oral use

Belgium

| Nycomed Belgium N.V. |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Belgium N.V.

Gentsesteenweg 615

B-1080 Brussel

Piroxidex

20 mg

Powder

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussel |

Pfizer S.A.

Boulevard de la Plaine 17

B-1050 Brussel

Feldene

20 mg

Capsule

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussel |

Pfizer S.A.

Boulevard de la Plaine 17

B-1050 Brussel

Feldene

10 mg

Capsule

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussel |

Pfizer S.A.

Boulevard de la Plaine 17

B-1050 Brussel

Feldene

20 mg

Suppository

Rectal use

Belgium

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussel |

Pfizer S.A.

Boulevard de la Plaine 17

B-1050 Brussel

Feldene

0,50 %

Gel

Transdermal use

Belgium

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussel |

Pfizer S.A.

Boulevard de la Plaine 17

B-1050 Brussel

Feldene

20 mg/ml

Solution for injection

Intramuscular use

Belgium

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussel |

Pfizer S.A.

Boulevard de la Plaine 17

B-1050 Brussel

Feldene Dispersal

20 mg

Tablet

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussel |

Pfizer S.A.

Boulevard de la Plaine 17

B-1050 Brussel

Feldene Lyotabs

10 mg

Lyophilisat

Oral use

Belgium

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussel |

Pfizer S.A.

Boulevard de la Plaine 17

B-1050 Brussel

Feldene Lyotabs

20 mg

Lyophilisat

Oral use

Belgium

| Pharmapartner NV |
| --- |
| Kolonel Begaultlaan 16 |
| B-3012 Leuven |

Pharmapartner NV

Kolonel Begaultlaan 16

B-3012 Leuven

Feldene Lyotabs

20 mg

Tablet

Oral use

Belgium

| Ratiopharm Belgium S.A. |
| --- |
| Rue Saint-Lambert 141 |
| B-1200 Bruxelles |

Ratiopharm Belgium S.A.

Rue Saint-Lambert 141

B-1200 Bruxelles

Piroxicam-Ratiopharm

20 mg

Suppository

Rectal use

Belgium

| Ratiopharm Belgium S.A. |
| --- |
| Rue Saint-Lambert 141 |
| B-1200 Bruxelles |

Ratiopharm Belgium S.A.

Rue Saint-Lambert 141

B-1200 Bruxelles

Piroxicam-Ratiopharm

10 mg

Tablet

Oral use

Belgium

| Ratiopharm Belgium S.A. |
| --- |
| Rue Saint-Lambert 141 |
| B-1200 Bruxelles |

Ratiopharm Belgium S.A.

Rue Saint-Lambert 141

B-1200 Bruxelles

Piroxicam-Ratiopharm

20 mg

Tablet

Oral use

Belgium

| Sandoz N.V. |
| --- |
| Telecom Ardens |
| Medialaan 40 |
| B-1800 Vilvoorde |

Sandoz N.V.

Telecom Ardens

Medialaan 40

B-1800 Vilvoorde

Piroxicam Sandoz

20 mg

Dispersible tablet

Oral use

Belgium

| Socobom N.V. |
| --- |
| Luoizalaan 149 Bus 4 |
| B-1050 Brussel |

Socobom N.V.

Luoizalaan 149 Bus 4

B-1050 Brussel

Polydene

20 mg

Dispersible tablet

Oral use

Belgium

| Teva Generics Belgium N.V. |
| --- |
| Laarstraat 16 |
| B-2610 Wilrijk |

Teva Generics Belgium N.V.

Laarstraat 16

B-2610 Wilrijk

Piroxicam Teva

10 mg

Capsule

Oral use

Belgium

| Teva Generics Belgium N.V. |
| --- |
| Laarstraat 16 |
| B-2610 Wilrijk |

Teva Generics Belgium N.V.

Laarstraat 16

B-2610 Wilrijk

Piroxicam Teva

20 mg

Suppository

Rectal use

Belgium

| Teva Generics Belgium N.V. |
| --- |
| Laarstraat 16 |
| B-2610 Wilrijk |

Teva Generics Belgium N.V.

Laarstraat 16

B-2610 Wilrijk

Piroxicam Teva

20 mg

Capsule

Oral use

Belgium

| Teva Generics Belgium N.V. |
| --- |
| Laarstraat 16 |
| B-2610 Wilrijk |

Teva Generics Belgium N.V.

Laarstraat 16

B-2610 Wilrijk

Piroxicam Teva

20 mg

Dispersible tablet

Oral use

Belgium

| Topgen Esv |
| --- |
| E. Demunterlaan 1/8 |
| B-1090 Brussel |

Topgen Esv

E. Demunterlaan 1/8

B-1090 Brussel

Piroxitop

20 mg

Tablet

Oral use

Belgium

| P.S.I. N.V. |
| --- |
| Kraanlei 27-29 |
| B-900 Gent |

P.S.I. N.V.

Kraanlei 27-29

B-900 Gent

Veralgesic

20 mg

Dispersible tablet

Oral use

Bulgaria

| Alkaloid Ltd |
| --- |
| 21 „Tzar Boris III“ Blvd |
| BG-1000 Sofia |

Alkaloid Ltd

21 „Tzar Boris III“ Blvd

BG-1000 Sofia

Piroxicam Alkaloid

20 mg

Capsule

Oral use

Bulgaria

| Sopharma AD |
| --- |
| 16 „Iliensko Shose“ str. |
| BG-1220 Sofia |

Sopharma AD

16 „Iliensko Shose“ str.

BG-1220 Sofia

Piroxicam Sopharma

10 mg

Capsule, hard

Oral use

Bulgaria

| Sopharma AD |
| --- |
| 16 „Iliensko Shose“ str. |
| BG-1220 Sofia |

Sopharma AD

16 „Iliensko Shose“ str.

BG-1220 Sofia

Piroxicam Sopharma

20 mg

Capsule, hard

Oral use

Bulgaria

| Sopharma AD |
| --- |
| 16 „Iliensko Shose“ str. |
| BG-1220 Sofia |

Sopharma AD

16 „Iliensko Shose“ str.

BG-1220 Sofia

Piroxicam Sopharma 1 %

1 g/100 g — 40 g

Gel

Cutaneous use

Bulgaria

| Sopharma AD |
| --- |
| 16 „Iliensko Shose“ str. |
| BG-1220 Sofia |

Sopharma AD

16 „Iliensko Shose“ str.

BG-1220 Sofia

Piroxicam Sopharma 0,5 %

0,5 g/100 g — 40 g

Gel

Cutaneous use

Bulgaria

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

Finalgel

0,5 g/100 g — 35 g; 50 g

Gel

Cutaneous use

Bulgaria

| Promedica S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin

20 mg

Tablet

Oral use

Bulgaria

| Promedica S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin

20 mg

Powder for oral solution

Oral use

Bulgaria

| Egis Pharmaceuticals Public Limited Company |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Public Limited Company

Keresztúri út 30-38.

H-1106 Budapest

Hotemin 10 mg capsule

10 mg

Capsule

Oral use

Bulgaria

| Egis Pharmaceuticals Public Limited Company |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Public Limited Company

Keresztúri út 30-38.

H-1106 Budapest

Hotemin 20 mg capsule

20 mg

Capsule

Oral use

Bulgaria

| Egis Pharmaceuticals Public Limited Company |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Public Limited Company

Keresztúri út 30-38.

H-1106 Budapest

Hotemin Injection

20 mg/ml-1 ml

Solution for injection

Intramuscular use

Bulgaria

| Egis Pharmaceuticals Public Limited Company |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Public Limited Company

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

20 mg

Suppository

Rectal use

Bulgaria

| Egis Pharmaceuticals Public Limited Company |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Public Limited Company

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

10 mg

Suppository

Rectal use

Bulgaria

| Egis Pharmaceuticals Public Limited Company |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Public Limited Company

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

0,5 g/50 g — 50 g

Cream

Cutaneous use

Cyprus

| Pfizer Hellas Ae |
| --- |
| 243 Mesogion Ave |
| GR-15451 N. Psychiko |

Pfizer Hellas Ae

243 Mesogion Ave

GR-15451 N. Psychiko

Feldene

10 mg

Tablet

Oral use

Cyprus

| Pfizer Hellas Ae |
| --- |
| 243 Mesogion Ave |
| GR-15451 N. Psychiko |

Pfizer Hellas Ae

243 Mesogion Ave

GR-15451 N. Psychiko

Feldene

20 mg

Dispersible tablet

Oral use

Cyprus

| Pfizer Hellas Ae |
| --- |
| 243 Mesogion Ave |
| GR-15451 N. Psychiko |

Pfizer Hellas Ae

243 Mesogion Ave

GR-15451 N. Psychiko

Feldene

20 mg

Suppository

Rectal use

Cyprus

| Pfizer Hellas Ae |
| --- |
| 243 Mesogion Ave |
| GR-15451 N. Psychiko |

Pfizer Hellas Ae

243 Mesogion Ave

GR-15451 N. Psychiko

Feldene

0,50 %

Gel

External use

Cyprus

| Pfizer Hellas Ae |
| --- |
| 243 Mesogion Ave |
| GR-15451 N. Psychiko |

Pfizer Hellas Ae

243 Mesogion Ave

GR-15451 N. Psychiko

Feldene

20 mg/ml 1 ml

Solution for injection

Intramuscular use

Cyprus

| Varnavas Hadjipanayis |
| --- |
| 7 Androcleous Str. |
| Pobox 21229 |
| CY-1504 Lefkosia |

Varnavas Hadjipanayis

7 Androcleous Str.

Pobox 21229

CY-1504 Lefkosia

Brexin

20 mg

Tablet

Oral use

Cyprus

| Medochemie Ltd |
| --- |
| Pobox 51409 |
| CY-3505 Lemesos |

Medochemie Ltd

Pobox 51409

CY-3505 Lemesos

Sotilen

10 mg

Capsule

Oral use

Cyprus

| Medochemie Ltd |
| --- |
| Pobox 51409 |
| CY-3505 Lemesos |

Medochemie Ltd

Pobox 51409

CY-3505 Lemesos

Sotilen

20 mg

Capsule

Oral use

Cyprus

| Medochemie Ltd |
| --- |
| Pobox 51409 |
| CY-3505 Lemesos |

Medochemie Ltd

Pobox 51409

CY-3505 Lemesos

Sotilen

1 %

Gel

External use

Cyprus

| Remedica Ltd |
| --- |
| Limassol Industrial Estate |
| AHarnon Str. |
| P.O Box 51706 |
| CY-3508 Limassol |

Remedica Ltd

Limassol Industrial Estate

AHarnon Str.

P.O Box 51706

CY-3508 Limassol

Roxitan

10 mg

Capsule

Oral use

Cyprus

| Remedica Ltd |
| --- |
| Limassol Industrial Estate |
| AHarnon Str. |
| P.O Box 51706 |
| CY-3508 Limassol |

Remedica Ltd

Limassol Industrial Estate

AHarnon Str.

P.O Box 51706

CY-3508 Limassol

Roxitan

20 mg

Capsule

Oral use

Czech Republic

| Egis Pharmaceuticals Ltd |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Ltd

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

20 mg/ml

Solution for injection

Intramuscular use

Czech Republic

| Egis Pharmaceuticals Ltd |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Ltd

Keresztúri út 30-38.

H-1106 Budapest

Hotemin 10 mg

10 mg

Capsule, hard

Oral use

Czech Republic

| Egis Pharmaceuticals Ltd |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Ltd

Keresztúri út 30-38.

H-1106 Budapest

Hotemin 20 mg

20 mg

Capsule, hard

Oral use

Czech Republic

| Egis Pharmaceuticals Ltd |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Ltd

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

10 mg/gm

Cream

Cutaneous use

Czech Republic

| Pro.Med.Cs Praha a.s. |
| --- |
| Telčská 1 |
| CZ-140 00 Praha 4 |

Pro.Med.Cs Praha a.s.

Telčská 1

CZ-140 00 Praha 4

Pro-Roxikam 10 mg

10 mg

Tablet

Oral use

Czech Republic

| Pro.Med.Cs Praha a.s. |
| --- |
| Telčská 1 |
| CZ-140 00 Praha 4 |

Pro.Med.Cs Praha a.s.

Telčská 1

CZ-140 00 Praha 4

Pro-Roxikam 20 mg

20 mg

Tablet

Oral use

Czech Republic

| Aliud Pharma GmbH & Co.Kg. |
| --- |
| Gottlieb-Daimler-Strasse 19 |
| D-89150 Laichingen |

Aliud Pharma GmbH & Co.Kg.

Gottlieb-Daimler-Strasse 19

D-89150 Laichingen

Piroxicam Al 10

10 mg

Tablet

Oral use

Piroxicam Al 20

20 mg

Czech Republic

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin

20 mg

Tablet

Oral use

Czech Republic

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin

20 mg

Granules

Oral use

Czech Republic

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin Eff

20 mg

Effervescent tablet

Oral use

Germany

| Abz-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |

Abz-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Piro 10 mg Abz

10231.00.00

10 mg

Tablet

Oral use

Germany

| Abz-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |

Abz-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Piro 20 mg Abz

10231.01.00

20 mg

Tablet

Oral use

Germany

| Acis Arzneimittel GmbH |
| --- |
| Bajuwarenring 14 |
| D-82041 Oberhaching |

Acis Arzneimittel GmbH

Bajuwarenring 14

D-82041 Oberhaching

Piroxicam Acis 20 mg Tabs

29562.00.00

20 mg

Tablet

Oral use

Germany

| Aliud Pharma GmbH & Co.Kg |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |

Aliud Pharma GmbH & Co.Kg

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Piroxicam Al 10

30314.00.00

10 mg

Tablet

Oral use

Germany

| Aliud Pharma GmbH & Co.Kg |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |

Aliud Pharma GmbH & Co.Kg

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Piroxicam Al 20

29583.00.00

20 mg

Tablet

Oral use

Germany

| Aliud Pharma GmbH & Co.Kg |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |

Aliud Pharma GmbH & Co.Kg

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Piroxicam Al 20 Brausetabletten

31544.00.00

20 mg

Effervescent tablet

Oral use

Germany

| Aliud Pharma GmbH & Co.Kg |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |

Aliud Pharma GmbH & Co.Kg

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Piroxicam Al 20 Zäpfchen

6412895.00.00

20 mg

Suppository

Rectal use

Germany

| Asche Chiesi GmbH |
| --- |
| Gasstr. 6 |
| D-22761 Hamburg |

Asche Chiesi GmbH

Gasstr. 6

D-22761 Hamburg

Brexidol 20 mg Granulat zur Herstellung einer Lösung zum Einnehmen

27116.00.01

20 mg/3 g

Granules

Oral use

Germany

| Asche Chiesi GmbH |
| --- |
| Gasstr. 6 |
| D-22761 Hamburg |

Asche Chiesi GmbH

Gasstr. 6

D-22761 Hamburg

Brexidol 20 mg Tabletten

27116.00.00

20 mg

Tablet

Oral use

Germany

| Asche Chiesi GmbH |
| --- |
| Gasstr. 6 |
| D-22761 Hamburg |

Asche Chiesi GmbH

Gasstr. 6

D-22761 Hamburg

Pc-Fice 20 mg Granulat zur Herstellung einer Lösung zum Einnehmen

28887.00.01

20 mg/3 g

Granules

Oral use

Germany

| Asche Chiesi GmbH |
| --- |
| Gasstr. 6 |
| D-22761 Hamburg |

Asche Chiesi GmbH

Gasstr. 6

D-22761 Hamburg

Pc-Fice 20 mg Tabletten

28887.00.00

20 mg

Tablet

Oral use

Germany

| Bc Biochemie Pharma GmbH |
| --- |
| Carl-Zeiss-Ring 3 |
| D-85737 Ismaning |

Bc Biochemie Pharma GmbH

Carl-Zeiss-Ring 3

D-85737 Ismaning

Fasax 10 mg Tabs

26221.00.00

10 mg

Tablet

Oral use

Germany

| Bc Biochemie Pharma GmbH |
| --- |
| Carl-Zeiss-Ring 3 |
| D-85737 Ismaning |

Bc Biochemie Pharma GmbH

Carl-Zeiss-Ring 3

D-85737 Ismaning

Fasax 20 mg Tabs

24902.00.00

20 mg

Tablet

Oral use

Germany

| Betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |

Betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Pirobeta 10

37338.00.00

10 mg

Tablet

Oral use

Germany

| Betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |

Betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Pirobeta 20

37338.01.00

20 mg

Tablet

Oral use

Germany

| Ct-Arzneimittel GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

Ct-Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Pirox-Ct 20 mg Tabletten

6156699.01.01

20 mg

Tablet

Oral use

Germany

| CT-Arzneimittel GmbH |
| --- |
| Lengeder Str. 42a |
| D-13407 Berlin |

CT-Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Pirox-CT 20 mg/1 ml Ampullen

6061697.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Docpharm Arzneimittelvertrieb GmbH & Co.Kgaa |
| --- |
| Reetzstr. 83 |
| D-76327 Pfinztal |

Docpharm Arzneimittelvertrieb GmbH & Co.Kgaa

Reetzstr. 83

D-76327 Pfinztal

Piroxicam Pb 10 mg

26223.00.00

10 mg

Tablet

Oral use

Germany

| Docpharm Arzneimittelvertrieb GmbH & Co.Kgaa |
| --- |
| Reetzstr. 83 |
| D-76327 Pfinztal |

Docpharm Arzneimittelvertrieb GmbH & Co.Kgaa

Reetzstr. 83

D-76327 Pfinztal

Piroxicam Pb 20 mg

26223.01.00

20 mg

Tablet

Oral use

Germany

| Dr. Kade Pharmazeutische Fabrik GmbH |
| --- |
| Rigistr. 2 |
| D-12277 Berlin |

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

D-12277 Berlin

Piro Kd 10 Tabs

36015.00.00

10 mg

Tablet

Oral use

Germany

| Dr. Kade Pharmazeutische Fabrik GmbH |
| --- |
| Rigistr. 2 |
| D-12277 Berlin |

Dr. Kade Pharmazeutische Fabrik GmbH

Rigistr. 2

D-12277 Berlin

Piro Kd 20 Tabs

34106.01.00

20 mg

Tablet

Oral use

Germany

| Heumann Pharma GmbH & Co. Generica Kg |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |

Heumann Pharma GmbH & Co. Generica Kg

Südwestpark 50

D-90449 Nürnberg

Piroxicam 10 Heumann

12426.00.00

10 mg

Tablet

Oral use

Germany

| Heumann Pharma GmbH & Co. Generica Kg |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |

Heumann Pharma GmbH & Co. Generica Kg

Südwestpark 50

D-90449 Nürnberg

Piroxicam 20 Heumann

12426.01.00

20 mg

Tablet

Oral use

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

A.M. Piroxicam 20

10013.00.00

20 mg

Suppository

Rectal use

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Ig 20 I.M.

53304.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Maxiflam 20 I.M. 53303.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Piro 20 I.M.

53307.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Pirorheum 20 I.M.

31511.00.01

20 mg/1 ml

Solution for injection

Injection

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Piroxicam Hexal 10 mg Tabs

9625.00.02

10 mg

Tablet

Oral use

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Piroxicam Hexal 20 I.M.

53306.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Piroxicam Hexal 20 mg Brausetabletten

31511.00.00

20 mg

Effervescent tablet

Oral use

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Piroxicam Hexal 20 mg Tabs

9625.01.02

20 mg

Tablet

Oral use

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Piroxicam Hexal 20 mg Zäpfchen

9625.00.01

20 mg

Suppository

Rectal use

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Piroxicam Hexal 20 mg/ml

3000887.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

Piroxiject 20 I.M.

53305.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Hexal Ag |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestr. 25

D-83607 Holzkirchen

TraumAHexal 20

29785.00.00

20 mg

Suppository

Rectal use

Germany

| Kohne Pharma GmbH |
| --- |
| Schallbruch 1 |
| D-42781 Haan |

Kohne Pharma GmbH

Schallbruch 1

D-42781 Haan

Piroxicam 20 mg Ako

37588.00.00

20 mg

Tablet

Oral use

Germany

| Merck Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

Merck Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Durapirox 20 mg

12638.00.00

20 mg

Capsule

Oral use

Germany

| Merck Dura GmbH |
| --- |
| Alsfelder Str. 19 |
| D-64289 Darmstadt |

Merck Dura GmbH

Alsfelder Str. 19

D-64289 Darmstadt

Durapirox 20 mg Tabs

9627.01.01

20 mg

Tablet

Oral use

Germany

| Mibe GmbH Arzneimittel |
| --- |
| Münchener Str. 15 |
| D-06796 Brehna |

Mibe GmbH Arzneimittel

Münchener Str. 15

D-06796 Brehna

Pirocutan 10 mg

29562.01.00

10 mg

Tablet

Oral use

Germany

| Mibe GmbH Arzneimittel |
| --- |
| Münchener Str. 15 |
| D-06796 Brehna |

Mibe GmbH Arzneimittel

Münchener Str. 15

D-06796 Brehna

Pirocutan 20 mg

39340.00.00

20 mg

Tablet

Oral use

Germany

| Mibe GmbH Arzneimittel |
| --- |
| Münchener Str. 15 |
| D-06796 Brehna |

Mibe GmbH Arzneimittel

Münchener Str. 15

D-06796 Brehna

Pirocutan Ampullen

6829336.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Mibe GmbH Arzneimittel |
| --- |
| Münchener Str. 15 |
| D-06796 Brehna |

Mibe GmbH Arzneimittel

Münchener Str. 15

D-06796 Brehna

Pirocutan Ampullen Mibe

48754.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Mibe Vertriebsgesellschaft Mbh |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |

Mibe Vertriebsgesellschaft Mbh

Otto-Schott-Str. 15

D-07745 Jena

Jenapirox I.M. 20 mg

6413185.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Mibe Vertriebsgesellschaft Mbh |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |

Mibe Vertriebsgesellschaft Mbh

Otto-Schott-Str. 15

D-07745 Jena

Jenapirox Tabs 10 mg

12637.00.00

10 mg

Tablet

Oral use

Germany

| Mibe Vertriebsgesellschaft Mbh |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |

Mibe Vertriebsgesellschaft Mbh

Otto-Schott-Str. 15

D-07745 Jena

Jenapirox Tabs 20 mg

9628.00.00

20 mg

Tablet

Oral use

Germany

| Mibe Vertriebsgesellschaft Mbh |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |

Mibe Vertriebsgesellschaft Mbh

Otto-Schott-Str. 15

D-07745 Jena

Piroxicam-KapseLN 10 mg Jenapharm

41597.00.00

10 mg

Capsule

Oral use

Germany

| Mibe Vertriebsgesellschaft Mbh |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |

Mibe Vertriebsgesellschaft Mbh

Otto-Schott-Str. 15

D-07745 Jena

Piroxicam-KapseLN 10 mg Jenapharm

6000413.01.00

10 mg

Capsule

Oral use

Germany

| Mibe Vertriebsgesellschaft Mbh |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |

Mibe Vertriebsgesellschaft Mbh

Otto-Schott-Str. 15

D-07745 Jena

Piroxicam-KapseLN 20 mg Jenapharm

41597.01.00

20 mg

Capsule

Oral use

Germany

| Mibe Vertriebsgesellschaft Mbh |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |

Mibe Vertriebsgesellschaft Mbh

Otto-Schott-Str. 15

D-07745 Jena

Piroxicam-KapseLN 20 mg Jenapharm

6000413.00.00

20 mg

Capsule

Oral use

Germany

| Pfizer Pharma GmbH |
| --- |
| Pfizerstr. 1 |
| D-76139 Karlsruhe |

Pfizer Pharma GmbH

Pfizerstr. 1

D-76139 Karlsruhe

Felden 20 mg Tabs

871.01.02

20 mg

Tablet

Oral use

Germany

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Piroxicam-Ratiopharm 10 mg Tabs

6013244.01.00

10 mg

Tablet

Oral use

Germany

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Piroxicam-Ratiopharm 20 mg Injektioslösung

6362849.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Piroxicam-Ratiopharm 20 mg Tabs

6013244.00.00

20 mg

Tablet

Oral use

Germany

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Piroxicam-Ratiopharm 20 Zäpfchen

6040355.00.00

20 mg

Suppository

Rectal use

Germany

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Piroxicam-Ratiopharm 20 mg Zäpfchen

10231.00.01

20 mg

Suppository

Rectal use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Carl-Zeiss-Ring 3 |
| D-85737 Ismaning |

Sandoz Pharmaceuticals GmbH

Carl-Zeiss-Ring 3

D-85737 Ismaning

Piroxicam Sandoz Parenteral 20 mg Injektionslösung

6139399.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Carl-Zeiss-Ring 3 |
| D-85737 Ismaning |

Sandoz Pharmaceuticals GmbH

Carl-Zeiss-Ring 3

D-85737 Ismaning

Piroxicam-Ac Suppos 20

30064.00.00

20 mg

Suppository

Rectal use

Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Carl-Zeiss-Ring 3 |
| D-85737 Ismaning |

Sandoz Pharmaceuticals GmbH

Carl-Zeiss-Ring 3

D-85737 Ismaning

Piroxicam-Sandoz Parenteral 20 mg Injektionslösung

53301.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Siemens & Co Heilwasser und Quellenprodukte des Staatsbades Bad Ems GmbH & Co.Kg |
| --- |
| Arzbacher Str. 78 |
| D-56130 Bad Ems |

Siemens & Co Heilwasser und Quellenprodukte des Staatsbades Bad Ems GmbH & Co.Kg

Arzbacher Str. 78

D-56130 Bad Ems

Piroxicam Hexal 10 mg Tabletten

9627.00.01

10 mg

Tablet

Oral use

Germany

| Siemens & Co Heilwasser und Quellenprodukte des Staatsbades Bad Ems GmbH & Co.Kg |
| --- |
| Arzbacher Str. 78 |
| D-56130 Bad Ems |

Siemens & Co Heilwasser und Quellenprodukte des Staatsbades Bad Ems GmbH & Co.Kg

Arzbacher Str. 78

D-56130 Bad Ems

Piroxicam Hexal 20 mg Tabletten

3000886.01.00

20 mg

Tablet

Oral use

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Piroxi 10 Stada Tabs

44091.00.00

10 mg

Tablet

Oral use

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Piroxi 20 Stada Tabs

44091.01.00

20 mg

Tablet

Oral use

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Piroxicam Stada

6346224.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Piroxicam Stada 10 mg KapseLN

23046.00.00

10 mg

Capsule

Oral use

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Piroxicam Stada 10 mg Tabs

6068067.00.00

10 mg

Tablet

Oral use

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Piroxicam Stada 20 mg KapseLN

23046.01.00

20 mg

Capsule

Oral use

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Piroxicam Stada 20 mg Brausetabletten

39728.00.00

20 mg

Effervescent tablet

Oral use

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Piroxicam Stada 20 mg Tabs

6068067.01.00

20 mg

Tablet

Oral use

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Piroxistad Injektionslösung 20 mg/ml

48755.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Pxi-10 Stada Tabs

28449.00.00

10 mg

Tablet

Oral use

Germany

| Stada GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |

Stada GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Pxi-20 Stada Tabs

28449.01.00

20 mg

Tablet

Oral use

Germany

| Tad Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |

Tad Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Flexase 10 Tabs

6691665.00.00

10 mg

Tablet

Oral use

Germany

| Tad Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |

Tad Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Flexase 10 mg Tabs

9625.00.00

10 mg

Tablet

Oral use

Germany

| Tad Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |

Tad Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Flexase 20 mg Tabs

9626.00.00

20 mg

Tablet

Oral use

Germany

| Tad Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |

Tad Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Flexase Ampullen

53300.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Tad Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |

Tad Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Flexase S

29786.00.00

20 mg

Suppository

Rectal use

Germany

| Tad Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |

Tad Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Flexase Uno

6691665.01.00

20 mg

Tablet

Oral use

Germany

| Weimer Pharma GmbH |
| --- |
| Im Steingerüst 30 |
| D-76437 Rastatt |

Weimer Pharma GmbH

Im Steingerüst 30

D-76437 Rastatt

Piroxicam Weimer Injektionslösung 20 mg/ml

49635.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Wieb Pharm Vertriebs GmbH & Co.Kg |
| --- |
| Diestraat 15 |
| D-25870 Norderfriedrichskoog |

Wieb Pharm Vertriebs GmbH & Co.Kg

Diestraat 15

D-25870 Norderfriedrichskoog

Pirowieb 20 Amp.

36620.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Wieb Pharm Vertriebs GmbH & Co.Kg |
| --- |
| Diestraat 15 |
| D-25870 Norderfriedrichskoog |

Wieb Pharm Vertriebs GmbH & Co.Kg

Diestraat 15

D-25870 Norderfriedrichskoog

Pirowieb 20 mg

12428.00.00

20 mg

Tablet

Oral use

Germany

| Wieb Pharm Vertriebs GmbH & Co.Kg |
| --- |
| Diestraat 15 |
| D-25870 Norderfriedrichskoog |

Wieb Pharm Vertriebs GmbH & Co.Kg

Diestraat 15

D-25870 Norderfriedrichskoog

Pirowieb 20 mg Inj.-Lsg.

53302.00.00

20 mg/1 ml

Solution for injection

Injection

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Industriestr. 10 |
| D-82256 Fürstenfeldbruck |

Winthrop Arzneimittel GmbH

Industriestr. 10

D-82256 Fürstenfeldbruck

Piroflam 10 mg

40937.00.00

10 mg

Capsule

Oral use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Industriestr. 10 |
| D-82256 Fürstenfeldbruck |

Winthrop Arzneimittel GmbH

Industriestr. 10

D-82256 Fürstenfeldbruck

Piroflam 10 mg Tabs Lichtenstein

6144727.00.00

10 mg

Tablet

Oral use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Industriestr. 10 |
| D-82256 Fürstenfeldbruck |

Winthrop Arzneimittel GmbH

Industriestr. 10

D-82256 Fürstenfeldbruck

Piroflam 20 mg Tabs Lichtenstein

6144727.01.00

20 mg

Tablet

Oral use

Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Industriestr. 10 |
| D-82256 Fürstenfeldbruck |

Winthrop Arzneimittel GmbH

Industriestr. 10

D-82256 Fürstenfeldbruck

Piroflam Suppos Lichtenstein

6144779.00.00

20 mg

Suppository

Rectal use

Denmark

| Merck NM AB |
| --- |
| Ynglingagatan 14 |
| 11347 Post Box 23033 |
| S-10435 Stockholm |

Merck NM AB

Ynglingagatan 14

11347 Post Box 23033

S-10435 Stockholm

Piroxicam »Merck NM«

10 mg

Tablet

Oral use

Denmark

| Merck NM AB |
| --- |
| Ynglingagatan 14 |
| 11347 Post Box 23033 |
| S-10435 Stockholm |

Merck NM AB

Ynglingagatan 14

11347 Post Box 23033

S-10435 Stockholm

Piroxicam »Merck NM«

20 mg

Tablet

Oral use

Denmark

| Merck NM AB |
| --- |
| Ynglingagatan 14 |
| 11347 Post Box 23033 |
| S-10435 Stockholm |

Merck NM AB

Ynglingagatan 14

11347 Post Box 23033

S-10435 Stockholm

Piroxicam »Merck NM«

10 mg

Capsule

Oral use

Denmark

| Merck NM AB |
| --- |
| Ynglingagatan 14 |
| 11347 Post Box 23033 |
| S-10435 Stockholm |

Merck NM AB

Ynglingagatan 14

11347 Post Box 23033

S-10435 Stockholm

Piroxicam »Merck NM«

20 mg

Capsule

Oral use

Denmark

| Pfizer Aps |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer Aps

Lautrupvang 8

DK-2750 Ballerup

Felden

20 mg

Dispersible tablet

Oral use

Denmark

| Pfizer Aps |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer Aps

Lautrupvang 8

DK-2750 Ballerup

Felden

0,5 %

Gel

Cutaneous use

Denmark

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Pirom

10 mg

Tablet

Oral use

Denmark

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |

Sandoz A/S

C.F. Tietgens Boulevard 40

DK-5220 Odense SØ

Pirom

20 mg

Tablet

Oral use

Denmark

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Piroxigea

10 mg

Tablet

Oral use

Denmark

| Hexal A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |

Hexal A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Piroxigea

20 mg

Tablet

Oral use

Greece

| DEMO ABEE |
| --- |
| 21st Km National Road |
| GR-14565 Athens-Lamia |

DEMO ABEE

21st Km National Road

GR-14565 Athens-Lamia

Oximezin

10 mg/tab

Gastro resistant tablet

Oral use

Greece

| DEMO ABEE |
| --- |
| 21st Km National Road |
| GR-14565 Athens-Lamia |

DEMO ABEE

21st Km National Road

GR-14565 Athens-Lamia

Oximezin

20 mg/tab

Gastro resistant tablet

Oral use

Greece

| DEMO ABEE |
| --- |
| 21st Km National Road |
| GR-14565 Athens-Lamia |

DEMO ABEE

21st Km National Road

GR-14565 Athens-Lamia

Oximezin

20 mg/1ml

Solution for injection

Intramuscular use

Greece

| DEMO ABEE |
| --- |
| 21st Km National Road |
| GR-14565 Athens-Lamia |

DEMO ABEE

21st Km National Road

GR-14565 Athens-Lamia

Oximezin

0,50 %

Gel

External use

Greece

| Pfizer Hellas Ae |
| --- |
| Mesogeion 243 |
| GR-15451 New Psychiko |

Pfizer Hellas Ae

Mesogeion 243

GR-15451 New Psychiko

Feldene

20 mg/sup

Suppository

Rectal use

Greece

| Pfizer Hellas Ae |
| --- |
| Mesogeion 243 |
| GR-15451 New Psychiko |

Pfizer Hellas Ae

Mesogeion 243

GR-15451 New Psychiko

Feldene

20 mg/tab

Dispersible tablet

Oral use

Greece

| Pfizer Hellas Ae |
| --- |
| Mesogeion 243 |
| GR-15451 New Psychiko |

Pfizer Hellas Ae

Mesogeion 243

GR-15451 New Psychiko

Feldene

10 mg/tab

Dispersible tablet

Oral use

Greece

| Pfizer Hellas Ae |
| --- |
| Mesogeion 243 |
| GR-15451 New Psychiko |

Pfizer Hellas Ae

Mesogeion 243

GR-15451 New Psychiko

Feldene

0,5 %

Gel

External use

Greece

| Pfizer Hellas Ae |
| --- |
| Mesogeion 243 |
| GR-15451 New Psychiko |

Pfizer Hellas Ae

Mesogeion 243

GR-15451 New Psychiko

Feldene

20 mg/1 ml

Solution for injection

Intramuscular use

Greece

| Pfizer Hellas Ae |
| --- |
| Mesogeion 243 |
| GR-15451 New Psychiko |

Pfizer Hellas Ae

Mesogeion 243

GR-15451 New Psychiko

Feldene

10 mg/tab

Tablet rapid

Oral use

Greece

| Pfizer Hellas Ae |
| --- |
| Mesogeion 243 |
| GR-15451 New Psychiko |

Pfizer Hellas Ae

Mesogeion 243

GR-15451 New Psychiko

Feldene

20 mg/tab

Tablet rapid

Oral use

Greece

| Biomedica-Chemica |
| --- |
| G. Lyra 25 |
| GR-14564 Kato Kifissia |

Biomedica-Chemica

G. Lyra 25

GR-14564 Kato Kifissia

Valopon

10 mg/cap

Hard capsules

Oral use

Greece

| Biomedica-Chemica |
| --- |
| G. Lyra 25 |
| GR-14564 Kato Kifissia |

Biomedica-Chemica

G. Lyra 25

GR-14564 Kato Kifissia

Valopon

20 mg/cap

Hard capsules

Oral use

Greece

| Biomedica-Chemica |
| --- |
| G. Lyra 25 |
| GR-14564 Kato Kifissia |

Biomedica-Chemica

G. Lyra 25

GR-14564 Kato Kifissia

Valopon

0,5 %

Gel

External use

Greece

| Biomedica-Chemica |
| --- |
| G. Lyra 25 |
| GR-14564 Kato Kifissia |

Biomedica-Chemica

G. Lyra 25

GR-14564 Kato Kifissia

Valopon

20 mg/1 ml

Solution for injection

Intramuscular use

Greece

| Remedina |
| --- |
| Gounari 25 & Areos |
| GR-13451 Kamatero Attiki |

Remedina

Gounari 25 & Areos

GR-13451 Kamatero Attiki

Flodeneu

20 mg/cap

Hard capsules

Oral use

Greece

| Pharmaceutical Industry Proel Ae E.G. Koronis |
| --- |
| Dilou 9 |
| GR-12134 Peristeri |

Pharmaceutical Industry Proel Ae E.G. Koronis

Dilou 9

GR-12134 Peristeri

Zerospam

20 mg/cap

Hard capsules

Oral use

Greece

| Pharmaceutical Industry Proel Ae E.G. Koronis |
| --- |
| Dilou 9 |
| GR-12134 Peristeri |

Pharmaceutical Industry Proel Ae E.G. Koronis

Dilou 9

GR-12134 Peristeri

Zerospam

0,5 %

Gel

External use

Greece

| Help Aebe |
| --- |
| Valaoritou 10 |
| GR-14452 Metamorfosi Attiki |

Help Aebe

Valaoritou 10

GR-14452 Metamorfosi Attiki

Proponol

20 mg/cap

Hard capsules

Oral use

Greece

| Help Aebe |
| --- |
| Valaoritou 10 |
| GR-14452 Metamorfosi Attiki |

Help Aebe

Valaoritou 10

GR-14452 Metamorfosi Attiki

Proponol

10 mg/cap

Hard capsules

Oral use

Greece

| Help Aebe |
| --- |
| Valaoritou 10 |
| GR-14452 Metamorfosi Attiki |

Help Aebe

Valaoritou 10

GR-14452 Metamorfosi Attiki

Proponol

20 mg/sup

Suppository

Rectal use

Greece

| Help Aebe |
| --- |
| Valaoritou 10 |
| GR-14452 Metamorfosi Attiki |

Help Aebe

Valaoritou 10

GR-14452 Metamorfosi Attiki

Proponol

0,5 %

Gel

External use

Greece

| Rafarm Aebe |
| --- |
| Korinthou 12 |
| GR-15451 New Psychiko |

Rafarm Aebe

Korinthou 12

GR-15451 New Psychiko

Zitumex

20 mg/cap

Hard capsules

Oral use

Greece

| Rafarm Aebe |
| --- |
| Korinthou 12 |
| GR-15451 New Psychiko |

Rafarm Aebe

Korinthou 12

GR-15451 New Psychiko

Zitumex

20 mg/sup

Suppository

Rectal use

Greece

| Rafarm Aebe |
| --- |
| Korinthou 12 |
| New Psychiko 15451 |
| Grèce |

Rafarm Aebe

Korinthou 12

New Psychiko 15451

Grèce

Zitumex

0,5 %

Gel

External use

Greece

| Rafarm Aebe |
| --- |
| Korinthou 12 |
| GR-15451 New Psychiko |

Rafarm Aebe

Korinthou 12

GR-15451 New Psychiko

Zitumex

20 mg/1 ml

Solution for injection

Intramuscular use

Greece

| Vilco Ae |
| --- |
| Pefkon 121 |
| GR-14122 Neo Irakleio |

Vilco Ae

Pefkon 121

GR-14122 Neo Irakleio

Pedifan

20 mg/cap

Hard capsules

Oral use

Greece

| Vilco Ae |
| --- |
| Pefkon 121 |
| GR-14122 Neo Irakleio |

Vilco Ae

Pefkon 121

GR-14122 Neo Irakleio

Pedifan

0,5 %

Gel

External use

Greece

| Faran Abee |
| --- |
| Achaias & Troizinias |
| GR-14564 New Kifissia |

Faran Abee

Achaias & Troizinias

GR-14564 New Kifissia

Calmopyrol

20 mg/cap

Hard capsules

Oral use

Greece

| Faran Abee |
| --- |
| Achaias & Troizinias |
| GR-14564 New Kifissia |

Faran Abee

Achaias & Troizinias

GR-14564 New Kifissia

Calmopyrol

20 mg/sup

Suppository

Rectal use

Greece

| MENTINOVA AE |
| --- |
| 16th Km Marathonos Avenue |
| GR-15344 Pallini Attiki |

MENTINOVA AE

16th Km Marathonos Avenue

GR-15344 Pallini Attiki

Conzila

20 mg/tab

Tablet

Oral use

Greece

| MENTINOVA AE |
| --- |
| 16th Km Marathonos Avenue |
| GR-15344 Pallini Attiki |

MENTINOVA AE

16th Km Marathonos Avenue

GR-15344 Pallini Attiki

Conzila

0,5 %

Gel

External use

Greece

| GENEPHARM AE |
| --- |
| 18th Km Marathonos Avenue |
| GR-15351 Pallini Attiki |

GENEPHARM AE

18th Km Marathonos Avenue

GR-15351 Pallini Attiki

Grecotens

20 mg/cap

Hard capsules

Oral use

Greece

| GENEPHARM AE |
| --- |
| 18th Km Marathonos Avenue |
| GR-15351 Pallini Attiki |

GENEPHARM AE

18th Km Marathonos Avenue

GR-15351 Pallini Attiki

Grecotens

0,5 %

Gel

External use

Greece

| Coup Oe Kouparoussos & Sia |
| --- |
| Agias Varvaras 53 |
| GR-17235 Dafni |

Coup Oe Kouparoussos & Sia

Agias Varvaras 53

GR-17235 Dafni

Ruvamed

20 mg/cap

Hard capsules

Oral use

Greece

| Coup Oe Kouparoussos & Sia |
| --- |
| Agias Varvaras 53 |
| GR-17235 Dafni |

Coup Oe Kouparoussos & Sia

Agias Varvaras 53

GR-17235 Dafni

Ruvamed

0,5 %

Gel

External use

Greece

| Kleva Epe |
| --- |
| Parnithos Avenue 189 |
| GR-13671 Acharnai Attiki |

Kleva Epe

Parnithos Avenue 189

GR-13671 Acharnai Attiki

Pyrcost

20 mg/cap

Hard capsules

Oral use

Greece

| Kleva Epe |
| --- |
| Parnithos Avenue 189 |
| GR-13671 Acharnai Attiki |

Kleva Epe

Parnithos Avenue 189

GR-13671 Acharnai Attiki

Pyrcost

0,5 %

Gel

External use

Greece

| Kleva Epe |
| --- |
| Parnithos Avenue 189 |
| GR-13671 Acharnai Attiki |

Kleva Epe

Parnithos Avenue 189

GR-13671 Acharnai Attiki

Pyrcost

20 mg/sup

Suppository

Rectal use

Greece

| Kleva Epe |
| --- |
| Parnithos Avenue 189 |
| GR-13671 Acharnai Attiki |

Kleva Epe

Parnithos Avenue 189

GR-13671 Acharnai Attiki

Pyrcost

20 mg/1 ml

Solution for injection

Intramuscular use

Greece

| Kleva Epe |
| --- |
| Parnithos Avenue 189 |
| GR-13671 Acharnai Attiki |

Kleva Epe

Parnithos Avenue 189

GR-13671 Acharnai Attiki

Felcam

10 mg/cap

Hard capsules

Oral use

Greece

| Kleva Epe |
| --- |
| Parnithos Avenue 189 |
| GR-13671 Acharnai Attiki |

Kleva Epe

Parnithos Avenue 189

GR-13671 Acharnai Attiki

Felcam

20 mg/cap

Hard capsules

Oral use

Greece

| Kleva Epe |
| --- |
| Parnithos Avenue 189 |
| GR-13671 Acharnai Attiki |

Kleva Epe

Parnithos Avenue 189

GR-13671 Acharnai Attiki

Felcam

0,5 %

Gel

External use

Greece

| Kleva Epe |
| --- |
| Parnithos Avenue 189 |
| GR-13671 Acharnai Attiki |

Kleva Epe

Parnithos Avenue 189

GR-13671 Acharnai Attiki

Felcam

20 mg/sup

Suppository

Rectal use

Greece

| Viostam K. Mpougias & Sia E.E. |
| --- |
| Padiamantopoulou 66 |
| GR-15771 Zografou Athens |

Viostam K. Mpougias & Sia E.E.

Padiamantopoulou 66

GR-15771 Zografou Athens

Painrelipt-D

0,5 %

Gel

External use

Greece

| Norma Hellas Ae |
| --- |
| Menandrou 54 |
| GR-10431 Athens |

Norma Hellas Ae

Menandrou 54

GR-10431 Athens

Neo Axedil

20 mg/cap

Hard capsules

Oral use

Greece

| Norma Hellas Ae |
| --- |
| Menandrou 54 |
| GR-10431 Athens |

Norma Hellas Ae

Menandrou 54

GR-10431 Athens

Neo Axedil

20 mg/1ml

Solution for injection

Intramuscular use

Greece

| Anfarm Hellas Ae |
| --- |
| K. Palaiologou & Perikleous 27 |
| GR-15232 Chalandri |

Anfarm Hellas Ae

K. Palaiologou & Perikleous 27

GR-15232 Chalandri

Bleduran

20 mg/cap

Hard capsules

Oral use

Greece

| Anfarm Hellas Ae |
| --- |
| K. Palaiologou & Perikleous 27 |
| GR-15232 Chalandri |

Anfarm Hellas Ae

K. Palaiologou & Perikleous 27

GR-15232 Chalandri

Bleduran

0,5 %

Gel

External use

Greece

| Gap Ae |
| --- |
| Agisilaou 46 |
| GR-17341 Agios Dimitrios |

Gap Ae

Agisilaou 46

GR-17341 Agios Dimitrios

Piroxicam/Gap

20 mg/cap

Hard capsules

Oral use

Greece

| Gap Ae |
| --- |
| Agisilaou 46 |
| GR-17341 Agios Dimitrios |

Gap Ae

Agisilaou 46

GR-17341 Agios Dimitrios

Piroxicam/Gap

10 mg/cap

Hard capsules

Oral use

Greece

| Chiesi Hellas Aebe |
| --- |
| Anapafseos Avenue 30 |
| GR-15235 Vrilissia |

Chiesi Hellas Aebe

Anapafseos Avenue 30

GR-15235 Vrilissia

Brexin

20 mg/sachet

Grannules for oral solution

Oral use

Greece

| Chiesi Hellas Aebe |
| --- |
| Anapafseos Avenue 30 |
| GR-15235 Vrilissia |

Chiesi Hellas Aebe

Anapafseos Avenue 30

GR-15235 Vrilissia

Brexin

20 mg/tab

Tablets

Oral use

Greece

| Chiesi Hellas Aebe |
| --- |
| Anapafseos Avenue 30 |
| GR-15235 Vrilissia |

Chiesi Hellas Aebe

Anapafseos Avenue 30

GR-15235 Vrilissia

Brexin

20 mg/tab

Effervescent tablets

Oral use

Greece

| Pharmanel Pharmaceutical Ae |
| --- |
| Marathonos 106 |
| GR-15344 Gerakas |

Pharmanel Pharmaceutical Ae

Marathonos 106

GR-15344 Gerakas

Sinartrol

15 mg/tab

Tablets

Oral use

Greece

| Pharmanel Pharmaceutical Ae |
| --- |
| Marathonos 106 |
| GR-15344 Gerakas |

Pharmanel Pharmaceutical Ae

Marathonos 106

GR-15344 Gerakas

Sinartrol

1,5 %

Cream

External use

Greece

| Pharmanel Pharmaceutical Ae |
| --- |
| Marathonos 106 |
| GR-15344 Gerakas |

Pharmanel Pharmaceutical Ae

Marathonos 106

GR-15344 Gerakas

Sinartrol

30 mg/tab

Tablets

Oral use

Spain

| Nefox Farma S.A. |
| --- |
| Avda. De Europa 20 B |
| E-28108 Alcobendas Madrid |

Nefox Farma S.A.

Avda. De Europa 20 B

E-28108 Alcobendas Madrid

Feldene

10 mg

Capsule, hard

Oral use

Spain

| Nefox Farma S.A. |
| --- |
| Avda. De Europa 20 B |
| E-28108 Alcobendas Madrid |

Nefox Farma S.A.

Avda. De Europa 20 B

E-28108 Alcobendas Madrid

Feldene

20 mg

Capsule, hard

Oral use

Spain

| Nefox Farma S.A. |
| --- |
| Avda. De Europa 20 B |
| E-28108 Alcobendas Madrid |

Nefox Farma S.A.

Avda. De Europa 20 B

E-28108 Alcobendas Madrid

Feldene

20 mg

Suppository

Rectal use

Spain

| Nefox Farma S.A. |
| --- |
| Avda. De Europa 20 B |
| E-28108 Alcobendas Madrid |

Nefox Farma S.A.

Avda. De Europa 20 B

E-28108 Alcobendas Madrid

Feldene

20 mg/ml

Solution for injection

Parenteral use

Spain

| Nefox Farma S.A. |
| --- |
| Avda. De Europa 20 B |
| E-28108 Alcobendas Madrid |

Nefox Farma S.A.

Avda. De Europa 20 B

E-28108 Alcobendas Madrid

Feldene

20 mg

Dispersible tablet

Oral use

Spain

| Nefox Farma S.A. |
| --- |
| Avda. De Europa 20 B |
| E-28108 Alcobendas Madrid |

Nefox Farma S.A.

Avda. De Europa 20 B

E-28108 Alcobendas Madrid

Feldene Flas

20 mg

Liophilised

Oral use

Spain

| Nefox Farma S.A. |
| --- |
| Avda. De Europa 20 B |
| E-28108 Alcobendas Madrid |

Nefox Farma S.A.

Avda. De Europa 20 B

E-28108 Alcobendas Madrid

Feldegel

10-60 g

Gel

Cutaneous use

Spain

| Chiesi España S.A. |
| --- |
| Av. Berlin 38-48 7a Planta |
| E-08029 Barcelona |

Chiesi España S.A.

Av. Berlin 38-48 7a Planta

E-08029 Barcelona

Brexinil

20 mg

Tablet

Oral use

Spain

| Chiesi España S.A. |
| --- |
| Av. Berlin 38-48 7a Planta |
| E-08029 Barcelona |

Chiesi España S.A.

Av. Berlin 38-48 7a Planta

E-08029 Barcelona

Brexinil

20 mg

Effervescent tablet

Oral use

Spain

| Chiesi España S.A. |
| --- |
| Av. Berlin 38-48 7a Planta |
| E-08029 Barcelona |

Chiesi España S.A.

Av. Berlin 38-48 7a Planta

E-08029 Barcelona

Brexinil Sobres

20 mg

Powder for oral solution

Oral use

Spain

| Chiesi España S.A. |
| --- |
| Av. Berlin 38-48 7a Planta |
| E-08029 Barcelona |

Chiesi España S.A.

Av. Berlin 38-48 7a Planta

E-08029 Barcelona

Cycladol

20 mg

Tablet

Oral use

Spain

| Chiesi España S.A. |
| --- |
| Av. Berlin 38-48 7a Planta |
| E-08029 Barcelona |

Chiesi España S.A.

Av. Berlin 38-48 7a Planta

E-08029 Barcelona

Cycladol Dref

20 mg

Effervescent tablet

Oral use

Spain

| Chiesi España S.A. |
| --- |
| Av. Berlin 38-48 7a Planta |
| E-08029 Barcelona |

Chiesi España S.A.

Av. Berlin 38-48 7a Planta

E-08029 Barcelona

Cycladol

20 mg

Powder for oral solution

Oral use

Spain

| Quimifar S.A. |
| --- |
| Comadran 37 |
| Barbera Del Valles |
| E-08210 Barcelona |

Quimifar S.A.

Comadran 37

Barbera Del Valles

E-08210 Barcelona

Doblexan

20 mg

Suppository

Rectal use

Spain

| Quimifar S.A. |
| --- |
| Comadran 37 |
| Barbera Del Valles |
| E-08210 Barcelona |

Quimifar S.A.

Comadran 37

Barbera Del Valles

E-08210 Barcelona

Doblexan

10 mg

Capsule

Oral use

Spain

| Quimifar S.A. |
| --- |
| Comadran 37 |
| Barbera Del Valles |
| E-08210 Barcelona |

Quimifar S.A.

Comadran 37

Barbera Del Valles

E-08210 Barcelona

Doblexan

20 mg

Capsule

Oral use

Spain

| Rottapharm S.L. |
| --- |
| Carretera De Barcelona 2 |
| E-46132 Almacera |

Rottapharm S.L.

Carretera De Barcelona 2

E-46132 Almacera

Improntal

10 mg

Capsule

Oral use

Spain

| Rottapharm S.L. |
| --- |
| Carretera De Barcelona 2 |
| E-46132 Almacera |

Rottapharm S.L.

Carretera De Barcelona 2

E-46132 Almacera

Improntal

20 mg

Capsule

Oral use

Spain

| Rottapharm S.L. |
| --- |
| Carretera De Barcelona 2 |
| E-46132 Almacera |

Rottapharm S.L.

Carretera De Barcelona 2

E-46132 Almacera

Improntal

20 mg

Dispersible tablet

Oral use

Spain

| Rottapharm S.L. |
| --- |
| Carretera De Barcelona 2 |
| E-46132 Almacera |

Rottapharm S.L.

Carretera De Barcelona 2

E-46132 Almacera

Improntal

5 mg/g

Cream

Cutaneous use

Spain

| Rottapharm S.L. |
| --- |
| Carretera De Barcelona 2 |
| E-46132 Almacera |

Rottapharm S.L.

Carretera De Barcelona 2

E-46132 Almacera

Improntal

20 mg/ml

Suppository

Rectal use

Spain

| Laboratorios Cinfa S.A. |
| --- |
| Olaz-Chipi 10. Polig. Areta |
| E-31620 Huarte Pamplona |

Laboratorios Cinfa S.A.

Olaz-Chipi 10. Polig. Areta

E-31620 Huarte Pamplona

Piroxicam Cinfa

20 mg

Dispersible tablet

Oral use

Spain

| Laboratorios Edigen S.A. |
| --- |
| Chile 8 2o Oficina 203. |
| Edificio Euromadrid |
| Las Matas |
| E-28290 Madrid |

Laboratorios Edigen S.A.

Chile 8 2o Oficina 203.

Edificio Euromadrid

Las Matas

E-28290 Madrid

Piroxicam Edigen

20 mg

Dispersible tablet

Oral use

Spain

| Pharmagenus S.A. |
| --- |
| Passeig De Gracia 55 5o 1a. |
| E-08007 Barcelona |

Pharmagenus S.A.

Passeig De Gracia 55 5o 1a.

E-08007 Barcelona

Piroxicam Pharmagenus

20 mg

Dispersible tablet

Oral use

Spain

| Ratiopharm España S.A. |
| --- |
| Avda. De Burgos 16 D-5a Planta |
| E-28036 Madrid |

Ratiopharm España S.A.

Avda. De Burgos 16 D-5a Planta

E-28036 Madrid

Piroxicam Ratiopharm

20 mg

Capsule

Oral use

Spain

| Ratiopharm España S.A. |
| --- |
| Avda. De Burgos 16 D-5a Planta |
| E-28036 Madrid |

Ratiopharm España S.A.

Avda. De Burgos 16 D-5a Planta

E-28036 Madrid

Piroxicam Ratiopharm

20 mg

Suppository

Rectal use

Spain

| Laboratorios Salvat |
| --- |
| S.A. Gallo 30-36 |
| E-08950 Barcelona |

Laboratorios Salvat

S.A. Gallo 30-36

E-08950 Barcelona

Salvacam

20 mg

Capsule

Oral use

Spain

| Laboratorios Salvat |
| --- |
| S.A. Gallo 30-36 |
| E-08950 Barcelona |

Laboratorios Salvat

S.A. Gallo 30-36

E-08950 Barcelona

Salvacam

0,5 %

Gel

Cutaneous use

Spain

| Laboratorios Faes Farma Sa |
| --- |
| Maximo Aguirre 14 |
| E-48940 Lamiaco-Lejona |

Laboratorios Faes Farma Sa

Maximo Aguirre 14

E-48940 Lamiaco-Lejona

Sasulen

20 mg

Capsule

Oral use

Spain

| Laboratorios Faes Farma Sa |
| --- |
| Maximo Aguirre 14 |
| E-48940 Lamiaco-Lejona |

Laboratorios Faes Farma Sa

Maximo Aguirre 14

E-48940 Lamiaco-Lejona

Sasulen

20 mg

Dispersible tablet

Oral use

Spain

| Laboratorios Faes Farma Sa |
| --- |
| Maximo Aguirre 14 |
| E-48940 Lamiaco-Lejona |

Laboratorios Faes Farma Sa

Maximo Aguirre 14

E-48940 Lamiaco-Lejona

Sasulen

0,5 %

Gel

Cutaneous use

Spain

| Laboratorios Faes Farma Sa |
| --- |
| Maximo Aguirre 14 |
| E-48940 Lamiaco-Lejona |

Laboratorios Faes Farma Sa

Maximo Aguirre 14

E-48940 Lamiaco-Lejona

Sasulen

20 mg

Suppository

Rectal use

Spain

| Laboratorios Robert S.A. |
| --- |
| Gran Via Carlos Iii 94 |
| E-08028 Barcelona |

Laboratorios Robert S.A.

Gran Via Carlos Iii 94

E-08028 Barcelona

Vitaxicam

20 mg

Capsule

Oral use

Spain

| Laboratorios Robert S.A. |
| --- |
| Gran Via Carlos Iii 94 |
| E-08028 Barcelona |

Laboratorios Robert S.A.

Gran Via Carlos Iii 94

E-08028 Barcelona

Vitaxicam

20 mg

Suppository

Rectal use

Spain

| Laboratorios Robert S.A. |
| --- |
| Gran Via Carlos Iii 94 |
| E-08028 Barcelona |

Laboratorios Robert S.A.

Gran Via Carlos Iii 94

E-08028 Barcelona

Vitaxicam Topico

0,5 %

Gel

Cutaneous use

Spain

| Laboratorios Robert S.A. |
| --- |
| Gran Via Carlos Iii 94 |
| E-08028 Barcelona |

Laboratorios Robert S.A.

Gran Via Carlos Iii 94

E-08028 Barcelona

Vitaxicam

10 mg

Tablet

Oral use

Estonia

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexin

20 mg

Tablet

Oral use

Estonia

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexin

20 mg

Powder for oral solution

Oral use

Estonia

| Pfizer Europe Ma Eeig |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent Ct13 9nj |
| United Kingdom |

Pfizer Europe Ma Eeig

Ramsgate Road

Sandwich

Kent Ct13 9nj

United Kingdom

Feldene

0,5 %

Gel

Transdermal use

Finland

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexidol

20 mg

Tablet

Oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 3 |
| FI-00330 Helsinki |

Pfizer Oy

Tietokuja 3

FI-00330 Helsinki

Felden

0,5 %

Gel

Cutaneous use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 3 |
| FI-00330 Helsinki |

Pfizer Oy

Tietokuja 3

FI-00330 Helsinki

Felden

20 mg

Capsule, hard

Oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 3 |
| FI-00330 Helsinki |

Pfizer Oy

Tietokuja 3

FI-00330 Helsinki

Felden

20 mg

Tablet

Oral use

Finland

| Alpharma A/S |
| --- |
| Harbitzalleen 3 |
| 158 Skoyen |
| N-0212 Oslo |

Alpharma A/S

Harbitzalleen 3

158 Skoyen

N-0212 Oslo

Piroxal

20 mg

Tablet

Oral use

Finland

| Merckle GmbH |
| --- |
| Ludwig-Merckle-Strasse 3 |
| P.O. Box 1161 |
| D-89143 Blaubeuren |

Merckle GmbH

Ludwig-Merckle-Strasse 3

P.O. Box 1161

D-89143 Blaubeuren

Piroxin

0,5 %

Gel

Cutaneous use

France

| Ajc Pharma |
| --- |
| 18 Rue Du Docteur Ragnaud |
| F-16000 Angoulême |

Ajc Pharma

18 Rue Du Docteur Ragnaud

F-16000 Angoulême

Zofora 20 mg Suppositoire

20 mg

Suppository

Rectal use

France

| Biogaran |
| --- |
| 15 Boulevard Charles De Gaulle |
| F-92707 Colombes Cedex |

Biogaran

15 Boulevard Charles De Gaulle

F-92707 Colombes Cedex

Piroxicam Biogaran 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Biogaran |
| --- |
| 15 Boulevard Charles De Gaulle |
| F-92707 Colombes Cedex |

Biogaran

15 Boulevard Charles De Gaulle

F-92707 Colombes Cedex

Piroxicam Biogaran 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Laboratoire Pharmy II |
| --- |
| 26 rue des Gaudines |
| F-78100 Saint-Germain-Laye |

Laboratoire Pharmy II

26 rue des Gaudines

F-78100 Saint-Germain-Laye

Zofora 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Laboratoire Pharmy II |
| --- |
| 26 rue des Gaudines |
| F-78100 Saint-Germain-Laye |

Laboratoire Pharmy II

26 rue des Gaudines

F-78100 Saint-Germain-Laye

Zofora 20 mg/1 ml Solution Injectable (I.M.)

20 mg

Solution for injection

Intramuscular use

France

| Laboratoire Pharmy II |
| --- |
| 26 rue des Gaudines |
| F-78100 Saint-Germain-Laye |

Laboratoire Pharmy II

26 rue des Gaudines

F-78100 Saint-Germain-Laye

Zofora 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Cephalon France |
| --- |
| 20 Rue Charles Martigny |
| F-94701 Maisons-Alfort Cedex |

Cephalon France

20 Rue Charles Martigny

F-94701 Maisons-Alfort Cedex

Proxalyoc 20 mg Lyophilisat oral

20 mg

Lyophilisat

Oral use

France

| Cephalon France |
| --- |
| 20 Rue Charles Martigny |
| F-94701 Maisons-Alfort Cedex |

Cephalon France

20 Rue Charles Martigny

F-94701 Maisons-Alfort Cedex

Proxalyoc 10 mg Lyophilisat oral

10 mg

Lyophilisat

Oral use

France

| Chiesi |
| --- |
| 11 Avenue Dubonnet |
| F-92400 Courbevoie |

Chiesi

11 Avenue Dubonnet

F-92400 Courbevoie

Cycladol 20 mg Comprimé effervescent

20 mg

Tablet

Oral use

France

| Chiesi |
| --- |
| 11 Avenue Dubonnet |
| F-92400 Courbevoie |

Chiesi

11 Avenue Dubonnet

F-92400 Courbevoie

Cycladol 20 mg Poudre pour suspension buvable en sachet

20 mg

Powder

Oral use

France

| Chiesi |
| --- |
| 11 Avenue Dubonnet |
| F-92400 Courbevoie |

Chiesi

11 Avenue Dubonnet

F-92400 Courbevoie

Cycladol 20 mg Comprimé sécable

20 mg

Tablet

Oral use

France

| Chiesi |
| --- |
| 11 Avenue Dubonnet |
| F-92400 Courbevoie |

Chiesi

11 Avenue Dubonnet

F-92400 Courbevoie

Cycladol 20 mg Suppositoire

20 mg

Suppository

Rectal use

France

| Dexo |
| --- |
| 179 Bureaux De La Colline |
| F-92213 Saint-Cloud Cedex |

Dexo

179 Bureaux De La Colline

F-92213 Saint-Cloud Cedex

Inflaced 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Dexo |
| --- |
| 179 Bureaux De La Colline |
| F-92213 Saint-Cloud Cedex |

Dexo

179 Bureaux De La Colline

F-92213 Saint-Cloud Cedex

Inflaced 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Dexo |
| --- |
| 179 Bureaux De La Colline |
| F-92213 Saint-Cloud Cedex |

Dexo

179 Bureaux De La Colline

F-92213 Saint-Cloud Cedex

Inflaced 20 mg Poudre effervescente en sachet

20 mg

Powder

Oral use

France

| Eg Labo — Laboratoires Eurogenerics |
| --- |
| «Le Quintet» — Bâtiment A |
| 12 Rue Danjou |
| F-92517 Boulogne Billancourt Cedex |

Eg Labo — Laboratoires Eurogenerics

«Le Quintet» — Bâtiment A

12 Rue Danjou

F-92517 Boulogne Billancourt Cedex

Piroxicam Eg 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Eg Labo — Laboratoires Eurogenerics |
| --- |
| «Le Quintet» — Bâtiment A |
| 12 Rue Danjou |
| F-92517 Boulogne Billancourt Cedex |

Eg Labo — Laboratoires Eurogenerics

«Le Quintet» — Bâtiment A

12 Rue Danjou

F-92517 Boulogne Billancourt Cedex

Piroxicam Eg 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Expanpharm International |
| --- |
| 6 rue de la Rochefoucauld |
| F-16000 Angouleme |

Expanpharm International

6 rue de la Rochefoucauld

F-16000 Angouleme

Piroxicam Expanpharm 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Expanpharm International |
| --- |
| 6 rue de la Rochefoucauld |
| F-16000 Angouleme |

Expanpharm International

6 rue de la Rochefoucauld

F-16000 Angouleme

Piroxicam Expanpharm 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Laboratories Fournier S.A. |
| --- |
| 42 Rue De Longvic |
| F-21300 Chenove |

Laboratories Fournier S.A.

42 Rue De Longvic

F-21300 Chenove

Piroxicam Fournier 20 mg/ml Solution injectable (Im)

20 mg

Solution for injection

Intramuscular use

France

| Innotech International |
| --- |
| 7-9 Avenue François-Vincent Raspail |
| Bp 32 |
| F-94111 Arcueil Cedex |

Innotech International

7-9 Avenue François-Vincent Raspail

Bp 32

F-94111 Arcueil Cedex

Pirotec 20 mg/1 ml Solution injectable

20 mg

Solution for injection

Intramuscular use

France

| Innotech International |
| --- |
| 7-9 Avenue François-Vincent Raspail |
| Bp 32 |
| F-94111 Arcueil Cedex |

Innotech International

7-9 Avenue François-Vincent Raspail

Bp 32

F-94111 Arcueil Cedex

Piroxicam Innotech International 20 mg/1 ml Solution injectable

20 mg

Solution for injection

Intramuscular use

France

| Innotech International |
| --- |
| 7-9 Avenue François-Vincent Raspail |
| Bp 32 |
| F-94111 Arcueil Cedex |

Innotech International

7-9 Avenue François-Vincent Raspail

Bp 32

F-94111 Arcueil Cedex

Piroxicam Innotech International 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Innotech International |
| --- |
| 7-9 Avenue François-Vincent Raspail |
| Bp 32 |
| F-94111 Arcueil Cedex |

Innotech International

7-9 Avenue François-Vincent Raspail

Bp 32

F-94111 Arcueil Cedex

Piroxicam Innotech International 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Innotech International |
| --- |
| 7-9 Avenue François-Vincent Raspail |
| Bp 32 |
| F-94111 Arcueil Cedex |

Innotech International

7-9 Avenue François-Vincent Raspail

Bp 32

F-94111 Arcueil Cedex

Pirotec 20 mg Suppositoire

20 mg

Suppository

Rectal use

France

| Innotech International |
| --- |
| 7-9 Avenue François-Vincent Raspail |
| Bp 32 |
| F-94111 Arcueil Cedex |

Innotech International

7-9 Avenue François-Vincent Raspail

Bp 32

F-94111 Arcueil Cedex

Piroxicam Innothera 20 mg Suppositoire

20 mg

Suppository

Rectal use

France

| Ivax Pharmaceuticals |
| --- |
| 34 Avenue Franklin Roosevelt |
| F-92150 Suresnes |

Ivax Pharmaceuticals

34 Avenue Franklin Roosevelt

F-92150 Suresnes

Piroxicam Ivax 20 mg/1 ml Solution injectable (Im)

20 mg

Solution for injection

Intramuscular use

France

| Ivax Pharmaceuticals |
| --- |
| 34 Avenue Franklin Roosevelt |
| F-92150 Suresnes |

Ivax Pharmaceuticals

34 Avenue Franklin Roosevelt

F-92150 Suresnes

Piroxicam Ivax 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Ivax Pharmaceuticals |
| --- |
| 34 Avenue Franklin Roosevelt |
| F-92150 Suresnes |

Ivax Pharmaceuticals

34 Avenue Franklin Roosevelt

F-92150 Suresnes

Piroxicam Ivax 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Ivax Pharmaceuticals |
| --- |
| 34 Avenue Franklin Roosevelt |
| F-92150 Suresnes |

Ivax Pharmaceuticals

34 Avenue Franklin Roosevelt

F-92150 Suresnes

Piroxicam Ivax 20 mg Suppositoire

20 mg

Suppository

Rectal use

France

| Laboratoire Rpg — Ranbaxy Pharmacie Generiques |
| --- |
| 4 Place Louis Armand |
| F-75012 Paris |

Laboratoire Rpg — Ranbaxy Pharmacie Generiques

4 Place Louis Armand

F-75012 Paris

Piroxicam Rpg 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Laboratoire Rpg — Ranbaxy Pharmacie Generiques |
| --- |
| 4 Place Louis Armand |
| F-75012 Paris |

Laboratoire Rpg — Ranbaxy Pharmacie Generiques

4 Place Louis Armand

F-75012 Paris

Piroxicam Rpg 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Merck Generiques |
| --- |
| 34 Rue Saint-Romain |
| F-69359 Lyon Cedex 08 |

Merck Generiques

34 Rue Saint-Romain

F-69359 Lyon Cedex 08

Piroxicam Merck 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Merck Generiques |
| --- |
| 34 Rue Saint-Romain |
| F-69359 Lyon Cedex 08 |

Merck Generiques

34 Rue Saint-Romain

F-69359 Lyon Cedex 08

Piroxicam Merck 20 mg/1 ml Solution Injectable (Im)

20 mg

Solution for injection

Intramuscular use

France

| Merck Generiques |
| --- |
| 34 Rue Saint-Romain |
| F-69359 Lyon Cedex 08 |

Merck Generiques

34 Rue Saint-Romain

F-69359 Lyon Cedex 08

Piroxicam Merck 20 mg Comprimé dispersible sécable

20 mg

Tablet

Oral use

France

| Merck Generiques |
| --- |
| 34 Rue Saint-Romain |
| F-69359 Lyon Cedex 08 |

Merck Generiques

34 Rue Saint-Romain

F-69359 Lyon Cedex 08

Piroxicam Merck 20 mg Suppositoire

20 mg

Suppository

Rectal use

France

| Merck Generiques |
| --- |
| 34 Rue Saint-Romain |
| F-69359 Lyon Cedex 08 |

Merck Generiques

34 Rue Saint-Romain

F-69359 Lyon Cedex 08

Piroxicam Merck 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Palbian |
| --- |
| Eurasanté — Parc Galénis |
| 85 C Rue Nelson Mandela |
| F-59120 Loos |

Palbian

Eurasanté — Parc Galénis

85 C Rue Nelson Mandela

F-59120 Loos

Piroxicam Palbian 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Palbian |
| --- |
| Eurasanté — Parc Galénis |
| 85 C Rue Nelson Mandela |
| F-59120 Loos |

Palbian

Eurasanté — Parc Galénis

85 C Rue Nelson Mandela

F-59120 Loos

Piroxicam Palbian 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Pfizer |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25 Avenue Du Docteur Lannelongue

F-75668 Paris Cedex 14

Feldene 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Pfizer |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25 Avenue Du Docteur Lannelongue

F-75668 Paris Cedex 14

Feldene 20 mg/1 ml Solution injectable en ampoule (Im)

20 mg

Solution for injection

Intramuscular use

France

| Pfizer |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25 Avenue Du Docteur Lannelongue

F-75668 Paris Cedex 14

Feldene 20 mg Suppositoire

20 mg

Suppository

Rectal use

France

| Pfizer |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25 Avenue Du Docteur Lannelongue

F-75668 Paris Cedex 14

Feldene Dispersible 20 mg Comprimé sécable

20 mg

Tablet

Oral use

France

| Pfizer |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25 Avenue Du Docteur Lannelongue

F-75668 Paris Cedex 14

Feldene 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Pfizer |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer

23-25 Avenue Du Docteur Lannelongue

F-75668 Paris Cedex 14

Geldene 0,5 Pour Cent Gel pour application locale

0,500 g

Gel

Cutaneous use

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75014 Paris |

Pfizer Holding France

23-25 Avenue Du Docteur Lannelongue

F-75014 Paris

Piroxicam Beral 20 mg Suppositoire

20 mg

Suppository

Rectal use

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75014 Paris |

Pfizer Holding France

23-25 Avenue Du Docteur Lannelongue

F-75014 Paris

Piroxicam Beral 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75014 Paris |

Pfizer Holding France

23-25 Avenue Du Docteur Lannelongue

F-75014 Paris

Piroxicam Beral Dispersible 20 mg Comprimé dispersible sécable

20 mg

Tablet

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75014 Paris |

Pfizer Holding France

23-25 Avenue Du Docteur Lannelongue

F-75014 Paris

Piroxicam Beral 20 mg/1 ml Solution injectable en ampoule (Im)

20 mg

Solution for injection

Intramuscular use

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75014 Paris |

Pfizer Holding France

23-25 Avenue Du Docteur Lannelongue

F-75014 Paris

Piroxicam Beral 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25 Avenue Du Docteur Lannelongue |
| F-75014 Paris |

Pfizer Holding France

23-25 Avenue Du Docteur Lannelongue

F-75014 Paris

Piroxicam Beral 0,5 Pour Cent Gel

0,5 g

Gel

Cutaneous use

France

| Pierre Fabre Medicament |
| --- |
| 45 Place Abel Gance |
| F-92654 Boulogne Cedex |

Pierre Fabre Medicament

45 Place Abel Gance

F-92654 Boulogne Cedex

Brexin 20 mg Poudre pour suspension buvable

20 mg

Powder

Oral use

France

| Pierre Fabre Medicament |
| --- |
| 45 Place Abel Gance |
| F-92654 Boulogne Cedex |

Pierre Fabre Medicament

45 Place Abel Gance

F-92654 Boulogne Cedex

Brexin 20 mg Suppositoire

20 mg

Suppository

Rectal use

France

| Pierre Fabre Medicament |
| --- |
| 45 Place Abel Gance |
| F-92654 Boulogne Cedex |

Pierre Fabre Medicament

45 Place Abel Gance

F-92654 Boulogne Cedex

Brexin 20 mg Comprimé effervescent

20 mg

Tablet

Oral use

France

| Pierre Fabre Medicament |
| --- |
| 45 Place Abel Gance |
| F-92654 Boulogne Cedex |

Pierre Fabre Medicament

45 Place Abel Gance

F-92654 Boulogne Cedex

Brexin 20 mg Comprimé sécable

20 mg

Tablet

Oral use

France

| Ratiopharm |
| --- |
| 5 Rue Charles Martigny |
| BP 42 |
| F-94702 Maisons-Alfort Cedex |

Ratiopharm

5 Rue Charles Martigny

BP 42

F-94702 Maisons-Alfort Cedex

Piroxicam-Ratiopharm 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Sandoz |
| --- |
| 49 Avenue Georges Pompidou |
| F-92300 Levallois-Perret |

Sandoz

49 Avenue Georges Pompidou

F-92300 Levallois-Perret

Piroxicam Sandoz 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Sandoz |
| --- |
| 49 Avenue Georges Pompidou |
| F-92300 Levallois-Perret |

Sandoz

49 Avenue Georges Pompidou

F-92300 Levallois-Perret

Piroxicam Gnr 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Teva Classics |
| --- |
| Le Palatin 1, |
| 1 Cours Du Triangle |
| F-92936 Paris La Défense Cedex |

Teva Classics

Le Palatin 1,

1 Cours Du Triangle

F-92936 Paris La Défense Cedex

Piroxicam Teva 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Teva Classics |
| --- |
| Le Palatin 1, |
| 1 Cours Du Triangle |
| F-92936 Paris La Défense Cedex |

Teva Classics

Le Palatin 1,

1 Cours Du Triangle

F-92936 Paris La Défense Cedex

Piroxicam Teva 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Teva Classics |
| --- |
| Le Palatin 1, |
| 1 Cours Du Triangle |
| F-92936 Paris La Défense Cedex |

Teva Classics

Le Palatin 1,

1 Cours Du Triangle

F-92936 Paris La Défense Cedex

Piroxicam Teva 20 mg/1 ml Solution injectable (Im)

20 mg

Solution for injection

Intramuscular use

France

| Teva Pharma B.V. |
| --- |
| Industrieweg 23 |
| Po Box 217 |
| 3640 Ae Mijdrecht |
| Nederland |

Teva Pharma B.V.

Industrieweg 23

Po Box 217

3640 Ae Mijdrecht

Nederland

Piroxicam Teva Pharma 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Teva Pharma B.V. |
| --- |
| Industrieweg 23 |
| Po Box 217 |
| 3640 Ae Mijdrecht |
| Nederland |

Teva Pharma B.V.

Industrieweg 23

Po Box 217

3640 Ae Mijdrecht

Nederland

Piroxicam Teva Pharma 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Meda Pharma |
| --- |
| 25 Boulevard de l'Amiral Bruix |
| F-75016 Paris |

Meda Pharma

25 Boulevard de l'Amiral Bruix

F-75016 Paris

Flexirox 20 mg/ml Solution injectable (Im)

20 mg

Solution for injection

Intramuscular use

France

| Meda Pharma |
| --- |
| 25 Boulevard de l'Amiral Bruix |
| F-75016 Paris |

Meda Pharma

25 Boulevard de l'Amiral Bruix

F-75016 Paris

Flexirox 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Meda Pharma |
| --- |
| 25 Boulevard de l'Amiral Bruix |
| F-75016 Paris |

Meda Pharma

25 Boulevard de l'Amiral Bruix

F-75016 Paris

Flexirox 20 mg Poudre effervescente en sachet-dose

20 mg

Powder

Oral use

France

| Meda Pharma |
| --- |
| 25 Boulevard de l'Amiral Bruix |
| F-75016 Paris |

Meda Pharma

25 Boulevard de l'Amiral Bruix

F-75016 Paris

Flexirox 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Meda Pharma |
| --- |
| 25 Boulevard de l'Amiral Bruix |
| F-75016 Paris |

Meda Pharma

25 Boulevard de l'Amiral Bruix

F-75016 Paris

Flexirox 2 mg/ml Suspension buvable en flacon

200 mg

Suspension

Oral use

France

| Winthrop Medicaments |
| --- |
| 1/13 Boulevard Romain Rolland |
| F-75014 Paris |

Winthrop Medicaments

1/13 Boulevard Romain Rolland

F-75014 Paris

Piroxicam Winthrop 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Winthrop Medicaments |
| --- |
| 1/13 Boulevard Romain Rolland |
| F-75014 Paris |

Winthrop Medicaments

1/13 Boulevard Romain Rolland

F-75014 Paris

Piroxicam Winthrop 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Winthrop Medicaments |
| --- |
| 1/13 Boulevard Romain Rolland |
| F-75014 Paris |

Winthrop Medicaments

1/13 Boulevard Romain Rolland

F-75014 Paris

Olcam 10 mg Gélule

10 mg

Capsule, hard

Oral use

France

| Winthrop Medicaments |
| --- |
| 1/13 Boulevard Romain Rolland |
| F-75014 Paris |

Winthrop Medicaments

1/13 Boulevard Romain Rolland

F-75014 Paris

Olcam 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Zydus France |
| --- |
| 25 rue des Peupliers |
| Zac Les Hautes Pâtures — Parc d'activités des Peupliers |
| F-92000 Nanterre |

Zydus France

25 rue des Peupliers

Zac Les Hautes Pâtures — Parc d'activités des Peupliers

F-92000 Nanterre

Piroxicam Zydus 20 mg Gélule

20 mg

Capsule, hard

Oral use

France

| Zydus France |
| --- |
| 25 rue des Peupliers |
| Zac Les Hautes Pâtures — Parc d'activités des Peupliers |
| F-92000 Nanterre |

Zydus France

25 rue des Peupliers

Zac Les Hautes Pâtures — Parc d'activités des Peupliers

F-92000 Nanterre

Piroxicam Zydus 10 mg Gélule

10 mg

Capsule, hard

Oral use

Hungary

| Aliud Pharma GmbH & Co. Kg. |
| --- |
| Gottlieb-Daimler Str. 19 |
| D-89150 Laichingen |

Aliud Pharma GmbH & Co. Kg.

Gottlieb-Daimler Str. 19

D-89150 Laichingen

Piroxicam Al

10 mg

Tablet

Oral use

Hungary

| Aliud Pharma GmbH & Co. Kg. |
| --- |
| Gottlieb-Daimler Str. 19 |
| D-89150 Laichingen |

Aliud Pharma GmbH & Co. Kg.

Gottlieb-Daimler Str. 19

D-89150 Laichingen

Piroxicam Al

20 mg

Tablet

Oral use

Hungary

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin

20 mg

Tablet

Oral use

Hungary

| Torrex Chiesi Pharma GmbH |
| --- |
| Gonzagagasse 16/16 |
| A-1010 Wien |

Torrex Chiesi Pharma GmbH

Gonzagagasse 16/16

A-1010 Wien

Brexin

20 mg

Tablet

Oral use

Hungary

| Egis Gyógyszergyár Nyrt. |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Gyógyszergyár Nyrt.

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

10 mg

Suppository

Rectal use

Hungary

| Egis Gyógyszergyár Nyrt. |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Gyógyszergyár Nyrt.

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

20 mg

Suppository

Rectal use

Hungary

| Egis Gyógyszergyár Nyrt. |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Gyógyszergyár Nyrt.

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

10 mg

Capsule

Oral use

Hungary

| Egis Gyógyszergyár Nyrt. |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Gyógyszergyár Nyrt.

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

20 mg

Capsule

Oral use

Hungary

| Egis Gyógyszergyár Nyrt. |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Gyógyszergyár Nyrt.

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

10 m/1 g

Cream

Topical use

Hungary

| Sandoz Hungaria Kft. |
| --- |
| Tímár út 8. |
| H-1034 Budapest |

Sandoz Hungaria Kft.

Tímár út 8.

H-1034 Budapest

Pirorheum

20 mg

Tablet

Oral use

Hungary

| Sandoz Hungaria Kft. |
| --- |
| Tímár út 8. |
| H-1034 Budapest |

Sandoz Hungaria Kft.

Tímár út 8.

H-1034 Budapest

Pirorheum

20 mg

Injection

Parenteral use

Hungary

| Pfizer Kft. |
| --- |
| Thurzó út 5/C |
| H-1133 Budapest |

Pfizer Kft.

Thurzó út 5/C

H-1133 Budapest

Feldene

10 mg

Capsule

Oral use

Hungary

| Pfizer Kft. |
| --- |
| Thurzó út 5/C |
| H-1133 Budapest |

Pfizer Kft.

Thurzó út 5/C

H-1133 Budapest

Feldene Dispersal

20 mg

Tablet

Oral use

Hungary

| Pfizer Kft. |
| --- |
| Thurzó út 5/C |
| H-1133 Budapest |

Pfizer Kft.

Thurzó út 5/C

H-1133 Budapest

Feldene Flash

20 mg

Tablet

Sublingual use

Hungary

| Biogal-Teva Pharma |
| --- |
| Rákóczi út 70-72. |
| H-1074 Budapest |

Biogal-Teva Pharma

Rákóczi út 70-72.

H-1074 Budapest

Piroxicam-B

20 mg

Capsule

Oral use

Hungary

| Biogal-Teva Pharma |
| --- |
| Rákóczi út 70-72. |
| H-1074 Budapest |

Biogal-Teva Pharma

Rákóczi út 70-72.

H-1074 Budapest

Piroxicam-B

10 mg

Capsule

Oral use

Hungary

| Teva Gyógyszergyár Zrt. |
| --- |
| Pallagi út 13. |
| H-4042 Debrecen |

Teva Gyógyszergyár Zrt.

Pallagi út 13.

H-4042 Debrecen

Huma-Pirocam

20 mg

Capsule

Oral use

Hungary

| Teva Gyógyszergyár Zrt. |
| --- |
| Pallagi út 13. |
| H-4042 Debrecen |

Teva Gyógyszergyár Zrt.

Pallagi út 13.

H-4042 Debrecen

Huma-Pirocam

10 mg

Capsule

Oral use

Hungary

| Slovakofarma AS |
| --- |
| Nitrianská 100 |
| SK-92027 Hlohovec |

Slovakofarma AS

Nitrianská 100

SK-92027 Hlohovec

Reumador

5 mg/1 g

Gel

Transdermal use

Ireland

| Trinity Chiesi Pharmaceuticals Ltd |
| --- |
| Cheadle Royal Business Park |
| Highfield Cheadle SK8 3GY |
| United Kingdom |

Trinity Chiesi Pharmaceuticals Ltd

Cheadle Royal Business Park

Highfield Cheadle SK8 3GY

United Kingdom

Brexidol 20 mg Tablets

20 mg

Tablet

Oral use

Ireland

| Trinity Chiesi Pharmaceuticals Ltd |
| --- |
| Cheadle Royal Business Park |
| Highfield Cheadle SK8 3GY |
| United Kingdom |

Trinity Chiesi Pharmaceuticals Ltd

Cheadle Royal Business Park

Highfield Cheadle SK8 3GY

United Kingdom

Brexidol 20 mg Effervescent Tablets

20 mg

Tablet

Oral use

Ireland

| Pfizer Limited |
| --- |
| Walton Oaks Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene 10 mg Capsules

10 mg

Capsule, hard

Oral use

Ireland

| Pfizer Limited |
| --- |
| Walton Oaks Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene 20 mg Capsules

20 mg

Capsule, hard

Oral use

Ireland

| Pfizer Limited |
| --- |
| Walton Oaks Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene Suppositories 20 mg

20 mg

Suppository

Rectal use

Ireland

| Pfizer Limited |
| --- |
| Walton Oaks Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene Gel 0,5 %

0,5 %

Gel

Topical use

Ireland

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Feldene Topigel

Gel

Topical use

Iceland

| Pfizer Aps |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer Aps

Lautrupvang 8

DK-2750 Ballerup

Felden

20 mg

Dispersible tablet

Oral use

Iceland

| Pfizer Aps |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer Aps

Lautrupvang 8

DK-2750 Ballerup

Felden Gel

0,5 %

Gel

Topical use

Italy

| Abc Farmaceutici S.p.A. |
| --- |
| Corso Vittorio Emanuele II 72 |
| I-10121 Torino |

Abc Farmaceutici S.p.A.

Corso Vittorio Emanuele II 72

I-10121 Torino

Piroxicam Abc

20 mg

Capsule, hard

Oral use

Italy

| Abc Farmaceutici S.p.A. |
| --- |
| Corso Vittorio Emanuele II 72 |
| I-10121 Torino |

Abc Farmaceutici S.p.A.

Corso Vittorio Emanuele II 72

I-10121 Torino

Piroxicam Abc

20 mg

Suppository

Rectal use

Italy

| Abc Farmaceutici S.p.A. |
| --- |
| Corso Vittorio Emanuele II 72 |
| I-10121 Torino |

Abc Farmaceutici S.p.A.

Corso Vittorio Emanuele II 72

I-10121 Torino

Piroxicam Abc

1 %

Gel

Cutaneous use

Italy

| Aesculapius Farmaceutici S.r.l. |
| --- |
| Via Cozzaglio 24 |
| I-25125 Brescia |

Aesculapius Farmaceutici S.r.l.

Via Cozzaglio 24

I-25125 Brescia

Clevian

1 %

Gel

Cutaneous use

Italy

| Bioprogress S.p.A. |
| --- |
| Via Aurelia 58 |
| I-00165 Roma |

Bioprogress S.p.A.

Via Aurelia 58

I-00165 Roma

Oxicam

20 mg

Capsule, hard

Oral use

Italy

| Bioprogress S.p.A. |
| --- |
| Via Aurelia 58 |
| I-00165 Roma |

Bioprogress S.p.A.

Via Aurelia 58

I-00165 Roma

Oxicam

1 %

Gel

Cutaneous use

Italy

| Bruschettini S.r.l. |
| --- |
| Via Isonzo 6 |
| I-16147 Genova |

Bruschettini S.r.l.

Via Isonzo 6

I-16147 Genova

Bruxicam

20 mg

Capsule, hard

Oral use

Italy

| Bruschettini S.r.l. |
| --- |
| Via Isonzo 6 |
| I-16147 Genova |

Bruschettini S.r.l.

Via Isonzo 6

I-16147 Genova

Bruxicam

20 mg

Suppository

Rectal use

Italy

| Bruschettini S.r.l. |
| --- |
| Via Isonzo 6 |
| I-16147 Genova |

Bruschettini S.r.l.

Via Isonzo 6

I-16147 Genova

Bruxicam

1 %

Cream

Cutaneous use

Italy

| Bruschettini S.r.l. |
| --- |
| Via Isonzo 6 |
| I-16147 Genova |

Bruschettini S.r.l.

Via Isonzo 6

I-16147 Genova

Piroftal

0,5 %

Eye drops, solution

Ocular use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexidol

20 mg

Tablet

Oral use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexidol

20 mg

Effervescent tablet

Oral use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexidol

20 mg

Granules for oral solution

Oral use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexidol

20 mg

Suppository

Rectal use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexin L

20 mg/2 ml

Powder and solvent for solution for injection

Intramuscular use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Pivaloxicam

30 mg

Capsule, hard

Oral use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Pivaloxicam

2 %

Cream

Cutaneous use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Pivaloxicam

30 mg

Capsule, hard

Oral use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Pivaloxicam

50 g

Cream

Cutaneous use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Pivaloxicam

40 g

Cream

Cutaneous use

Italy

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Pivaloxicam

30 g

Cream

Cutaneous use

Italy

| Copernico S.r.l. |
| --- |
| Via Oria 32 |
| I-72028 Torre Santa Susanna (Br) |

Copernico S.r.l.

Via Oria 32

I-72028 Torre Santa Susanna (Br)

Euroxi

20 mg

Capsule, hard

Oral use

Italy

| Copernico S.r.l. |
| --- |
| Via Oria 32 |
| I-72028 Torre Santa Susanna (Br) |

Copernico S.r.l.

Via Oria 32

I-72028 Torre Santa Susanna (Br)

Euroxi

50 g

Gel

Cutaneous use

Italy

| Copernico S.r.l. |
| --- |
| Via Oria 32 |
| I-72028 Torre Santa Susanna (Br) |

Copernico S.r.l.

Via Oria 32

I-72028 Torre Santa Susanna (Br)

Spirox

20 mg/1 ml

Solution for injection

Intramuscular use

Italy

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| I-20124 Milano |

Doc Generici S.r.l.

Via Manuzio 7

I-20124 Milano

Piroxicam Doc

20 mg

Capsule, hard

Oral use

Italy

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| I-20124 Milano |

Doc Generici S.r.l.

Via Manuzio 7

I-20124 Milano

Piroxicam Doc

1 %

Cream

Cutaneous use

Italy

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| I-20124 Milano |

Doc Generici S.r.l.

Via Manuzio 7

I-20124 Milano

Piroxicam Doc

20 mg/ml

Solution for injection

Intramuscular use

Italy

| Doc Generici S.r.l. |
| --- |
| Via Manuzio 7 |
| I-20124 Milano |

Doc Generici S.r.l.

Via Manuzio 7

I-20124 Milano

Piroxicam Doc Generici

20 mg

Capsule, hard

Oral use

Italy

| Dorom S.r.l. |
| --- |
| Viale G. Richard 7 |
| I-20143 Milano |

Dorom S.r.l.

Viale G. Richard 7

I-20143 Milano

Piroxicam

10 mg

Capsule, hard

Oral use

Italy

| Dorom S.r.l. |
| --- |
| Viale G. Richard 7 |
| I-20143 Milano |

Dorom S.r.l.

Viale G. Richard 7

I-20143 Milano

Piroxicam

20 mg

Suppository

Rectal use

Italy

| Eg S.p.A. |
| --- |
| Via Scarlatti Domenico 31 |
| I-20124 Milano |

Eg S.p.A.

Via Scarlatti Domenico 31

I-20124 Milano

Piroxicam Eg

20 mg/ml

Solution for injection

Intramuscular use

Italy

| Eg S.p.A. |
| --- |
| Via Scarlatti Domenico 31 |
| I-20124 Milano |

Eg S.p.A.

Via Scarlatti Domenico 31

I-20124 Milano

Piroxicam Eg

20 mg

Capsule, hard

Oral use

Italy

| Eg S.p.A. |
| --- |
| Via Scarlatti Domenico 31 |
| I-20124 Milano |

Eg S.p.A.

Via Scarlatti Domenico 31

I-20124 Milano

Piroxicam Eg

20 mg

Soluble tablet

Oral use

Italy

| Epifarma S.r.l. |
| --- |
| Via S. Rocco 6 |
| I-85033 Episcopia Pz |

Epifarma S.r.l.

Via S. Rocco 6

I-85033 Episcopia Pz

Ipsoflog

20 mg

Capsule, hard

Oral use

Italy

| Epifarma S.r.l. |
| --- |
| Via S. Rocco 6 |
| I-85033 Episcopia Pz |

Epifarma S.r.l.

Via S. Rocco 6

I-85033 Episcopia Pz

Ipsoflog

1 %

Cream

Cutaneous use

Italy

| Epifarma S.r.l. |
| --- |
| Via S. Rocco 6 |
| I-85033 Episcopia Pz |

Epifarma S.r.l.

Via S. Rocco 6

I-85033 Episcopia Pz

Ipsoflog

20 mg/ 1 ml

Solution for injection

Intramuscular use

Italy

| Epifarma S.r.l. |
| --- |
| Via S. Rocco 6 |
| I-85033 Episcopia Pz |

Epifarma S.r.l.

Via S. Rocco 6

I-85033 Episcopia Pz

Ipsoflog

20 mg

Soluble tablet

Oral use

Italy

| F.I.R.M.A. S.p.A. |
| --- |
| Via di Scandicci 37 |
| I-50143 Firenze |

F.I.R.M.A. S.p.A.

Via di Scandicci 37

I-50143 Firenze

Antiflog

10 mg

Capsule, soft

Oral use

Italy

| F.I.R.M.A. S.p.A. |
| --- |
| Via di Scandicci 37 |
| I-50143 Firenze |

F.I.R.M.A. S.p.A.

Via di Scandicci 37

I-50143 Firenze

Antiflog

20 mg

Capsule, soft

Oral use

Italy

| F.I.R.M.A. S.p.A. |
| --- |
| Via di Scandicci 37 |
| I-50143 Firenze |

F.I.R.M.A. S.p.A.

Via di Scandicci 37

I-50143 Firenze

Antiflog

20 mg

Suppository

Rectal use

Italy

| F.I.R.M.A. S.p.A. |
| --- |
| Via di Scandicci 37 |
| I-50143 Firenze |

F.I.R.M.A. S.p.A.

Via di Scandicci 37

I-50143 Firenze

Antiflog

1 %

Gel

Cutaneous use

Italy

| Farma 1 S.r.l. |
| --- |
| Via privata Maria Teresa 11 |
| I-20123 Milano |

Farma 1 S.r.l.

Via privata Maria Teresa 11

I-20123 Milano

Flodol

20 mg

Capsule, hard

Oral use

Italy

| Farma 1 S.r.l. |
| --- |
| Via Privata Maria Teresa 11 |
| I-20123 Milano |

Farma 1 S.r.l.

Via Privata Maria Teresa 11

I-20123 Milano

Flodol

1 %

Gel

Cutaneous use

Italy

| Farmaceutici Caber S.p.A. |
| --- |
| Viale Città d'Europa 681 |
| I-00100 Roma |

Farmaceutici Caber S.p.A.

Viale Città d'Europa 681

I-00100 Roma

Roxenil

1 %

Cream

Cutaneous use

Italy

| Farmaceutici Caber S.p.A. |
| --- |
| Viale Città d'Europa 681 |
| I-00100 Roma |

Farmaceutici Caber S.p.A.

Viale Città d'Europa 681

I-00100 Roma

Roxenil

20 mg

Capsule, hard

Oral use

Italy

| Hexal S.p.A. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso 16 |
| I-20041 Agrate Brianza (Mi) |

Hexal S.p.A.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso 16

I-20041 Agrate Brianza (Mi)

Piroxicam Hexal

10 mg

Tablet

Oral use

Italy

| Hexal S.p.A. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso 16 |
| I-20041 Agrate Brianza (Mi) |

Hexal S.p.A.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso 16

I-20041 Agrate Brianza (Mi)

Piroxicam Hexal

20 mg

Tablet

Oral use

Italy

| Hexal S.p.A. |
| --- |
| Centro Direzionale Colleoni |
| Palazzo Andromeda |
| Via Paracelso 16 |
| I-20041 Agrate Brianza (Mi) |

Hexal S.p.A.

Centro Direzionale Colleoni

Palazzo Andromeda

Via Paracelso 16

I-20041 Agrate Brianza (Mi)

Piroxicam Hexal

20 mg

Solution for injection

Intramuscular use

Italy

| Jet Generici S.r.l. |
| --- |
| Via Mario Lalli 8 |
| I-56127 Pisa |

Jet Generici S.r.l.

Via Mario Lalli 8

I-56127 Pisa

Piroxicam

20 mg

Capsule, hard

Oral use

Italy

| K.B.R. Kroton Biologic Researches S.r.l. |
| --- |
| Corso V. Emanuele 73 |
| I-88074 Crotone (Kr) |

K.B.R. Kroton Biologic Researches S.r.l.

Corso V. Emanuele 73

I-88074 Crotone (Kr)

Reumagil

1 %

Cream

Cutaneous use

Italy

| K.B.R. Kroton Biologic Researches S.r.l. |
| --- |
| Corso V. Emanuele 73 |
| I-88074 Crotone (Kr) |

K.B.R. Kroton Biologic Researches S.r.l.

Corso V. Emanuele 73

I-88074 Crotone (Kr)

Reumagil

20 mg/1 ml

Solution for injection

Intramuscular use

Italy

| Laboratori Alter S.r.l. |
| --- |
| Via Egadi 7 |
| I-20144 Milano |

Laboratori Alter S.r.l.

Via Egadi 7

I-20144 Milano

Piroxicam Alter

20 mg/1 ml

Solution for injection

Intramuscular use

Italy

| Laboratori Prodotti Farmaceutici Boniscontro e Gazzone S.r.l. |
| --- |
| Via Pavia 6 |
| I-20136 Milano |

Laboratori Prodotti Farmaceutici Boniscontro e Gazzone S.r.l.

Via Pavia 6

I-20136 Milano

Roxiden

20 mg

Capsule, hard

Oral use

Italy

| Laboratori Prodotti Farmaceutici Boniscontro e Gazzone S.r.l. |
| --- |
| Via Pavia 6 |
| I-20136 Milano |

Laboratori Prodotti Farmaceutici Boniscontro e Gazzone S.r.l.

Via Pavia 6

I-20136 Milano

Roxiden

20 mg

Suppository

Rectal use

Italy

| Laboratori Prodotti Farmaceutici Boniscontro e Gazzone S.r.l. |
| --- |
| Via Pavia 6 |
| I-20136 Milano |

Laboratori Prodotti Farmaceutici Boniscontro e Gazzone S.r.l.

Via Pavia 6

I-20136 Milano

Roxiden

1 %

Gel

Cutaneous use

Italy

| Laboratori Prodotti Farmaceutici Boniscontro e Gazzone S.r.l. |
| --- |
| Via Pavia 6 |
| I-20136 Milano |

Laboratori Prodotti Farmaceutici Boniscontro e Gazzone S.r.l.

Via Pavia 6

I-20136 Milano

Roxiden

20 mg

Solution for injection

Intramuscular use

Italy

| Laboratorio Farmaceutico C.T. S.r.l. |
| --- |
| Strada Solaro 75/77 |
| I-18038 Villa Sayonara — Sanremo (Im) |
| Italie |

Laboratorio Farmaceutico C.T. S.r.l.

Strada Solaro 75/77

I-18038 Villa Sayonara — Sanremo (Im)

Italie

Reucam

10 mg

Capsule, hard

Oral use

Italy

| Laboratorio Farmaceutico C.T. S.r.l. |
| --- |
| Strada Solaro 75/77 |
| I-18038 Villa Sayonara — Sanremo (Im) |

Laboratorio Farmaceutico C.T. S.r.l.

Strada Solaro 75/77

I-18038 Villa Sayonara — Sanremo (Im)

Reucam

20 mg

Capsule, hard

Oral use

Italy

| Laboratorio Farmaceutico C.T. S.r.l. |
| --- |
| Strada Solaro 75/77 |
| I-18038 Villa Sayonara — Sanremo (Im) |

Laboratorio Farmaceutico C.T. S.r.l.

Strada Solaro 75/77

I-18038 Villa Sayonara — Sanremo (Im)

Reucam

20 mg

Suppository

Rectal use

Italy

| Laboratorio Farmaceutico C.T. S.r.l. |
| --- |
| Strada Solaro 75/77 |
| I-18038 Villa Sayonara — Sanremo (Im) |

Laboratorio Farmaceutico C.T. S.r.l.

Strada Solaro 75/77

I-18038 Villa Sayonara — Sanremo (Im)

Reucam

1 %

Cream

Cutaneous use

Italy

| Lampugnani Farmaceutici S.p.A. |
| --- |
| Bianca Maria Visconti 33 |
| I-20100 Milano |

Lampugnani Farmaceutici S.p.A.

Bianca Maria Visconti 33

I-20100 Milano

Lampoflex

1 %

Cream

Cutaneous use

Italy

| Lampugnani Farmaceutici S.p.A. |
| --- |
| Bianca Maria Visconti 33 |
| I-20100 Milano |

Lampugnani Farmaceutici S.p.A.

Bianca Maria Visconti 33

I-20100 Milano

Lampoflex

20 mg

Capsule, hard

Oral use

Italy

| Lampugnani Farmaceutici S.p.A. |
| --- |
| Bianca Maria Visconti 33 |
| I-20100 Milano |

Lampugnani Farmaceutici S.p.A.

Bianca Maria Visconti 33

I-20100 Milano

Lampoflex

1 %

Cutaneous foam

Cutaneous use

Italy

| Master Pharma S.r.l. |
| --- |
| Via Giacomo Chiesi |
| I-43100 Parma |

Master Pharma S.r.l.

Via Giacomo Chiesi

I-43100 Parma

Cicladol

20 mg

Granules for oral solution

Oral use

Italy

| Master Pharma S.r.l. |
| --- |
| Via Giacomo Chiesi |
| I-43100 Parma |

Master Pharma S.r.l.

Via Giacomo Chiesi

I-43100 Parma

Cicladol

20 mg

Suppository

Rectal use

Italy

| Master Pharma S.r.l. |
| --- |
| Via Giacomo Chiesi |
| I-43100 Parma |

Master Pharma S.r.l.

Via Giacomo Chiesi

I-43100 Parma

Cicladol

20 mg

Tablet

Oral use

Italy

| Master Pharma S.r.l. |
| --- |
| Via Giacomo Chiesi |
| I-43100 Parma |

Master Pharma S.r.l.

Via Giacomo Chiesi

I-43100 Parma

Cicladol

20 mg

Effervescent tablet

Oral use

Italy

| Master Pharma S.r.l. |
| --- |
| Via Giacomo Chiesi |
| I-43100 Parma |

Master Pharma S.r.l.

Via Giacomo Chiesi

I-43100 Parma

Ciclafast

30 mg

Capsule, hard

Oral use

Italy

| Master Pharma S.r.l. |
| --- |
| Via Giacomo Chiesi |
| I-43100 Parma |

Master Pharma S.r.l.

Via Giacomo Chiesi

I-43100 Parma

Ciclafast

2 %

Cream

Cutaneous use

Italy

| Mayne Pharma S.r.l. |
| --- |
| Via Orazio 20/22 |
| I-80122 Napoli |

Mayne Pharma S.r.l.

Via Orazio 20/22

I-80122 Napoli

Polipirox

20 mg

Capsule, hard

Oral use

Italy

| Mayne Pharma S.r.l. |
| --- |
| Via Orazio 20/22 |
| I-80122 Napoli |

Mayne Pharma S.r.l.

Via Orazio 20/22

I-80122 Napoli

Polipirox

20 mg

Suppository

Rectal use

Italy

| Mayne Pharma S.r.l. |
| --- |
| Via Orazio 20/22 |
| I-80122 Napoli |

Mayne Pharma S.r.l.

Via Orazio 20/22

I-80122 Napoli

Polipirox

20 mg/ml

Solution for injection

Intramuscular use

Italy

| Merck Generics Italia S.p.A. |
| --- |
| Via Aquileia 35 |
| I-20092 Cinisello Balsamo (Mi) |

Merck Generics Italia S.p.A.

Via Aquileia 35

I-20092 Cinisello Balsamo (Mi)

Piroxicam

20 mg/1 ml

Solution for injection

Intramuscular use

Italy

| Officina Farmaceutica Fiorentina S.r.l. |
| --- |
| Quartiere Varignano 12-13-14 |
| I-55049 Viareggio (Lu) |

Officina Farmaceutica Fiorentina S.r.l.

Quartiere Varignano 12-13-14

I-55049 Viareggio (Lu)

Dexicam

10 mg

Capsule

Oral use

Italy

| Officina Farmaceutica Fiorentina S.r.l. |
| --- |
| Quartiere Varignano 12-13-14 |
| I-55049 Viareggio (Lu) |

Officina Farmaceutica Fiorentina S.r.l.

Quartiere Varignano 12-13-14

I-55049 Viareggio (Lu)

Dexicam

20 mg

Capsule

Oral use

Italy

| Officina Farmaceutica Fiorentina S.r.l. |
| --- |
| Quartiere Varignano 12-13-14 |
| I-55049 Viareggio (Lu) |

Officina Farmaceutica Fiorentina S.r.l.

Quartiere Varignano 12-13-14

I-55049 Viareggio (Lu)

Dexicam

20 mg

Suppository

Rectal use

Italy

| Officina Farmaceutica Fiorentina S.r.l. |
| --- |
| Quartiere Varignano 12-13-14 |
| I-55049 Viareggio (Lu) |

Officina Farmaceutica Fiorentina S.r.l.

Quartiere Varignano 12-13-14

I-55049 Viareggio (Lu)

Dexicam

1 %

Gel

Cutaneous use

Italy

| Pfizer Consumer Health Care S.r.l. |
| --- |
| Strada Statale 156 Km 50 |
| I-04010 Borgo San Michele (Lt) |

Pfizer Consumer Health Care S.r.l.

Strada Statale 156 Km 50

I-04010 Borgo San Michele (Lt)

Raia

20 mg

Sublingual tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156 Km 50 |
| I-04010 Borgo San Michele (Lt) |

Pfizer Italia S.r.l.

S.S. 156 Km 50

I-04010 Borgo San Michele (Lt)

Feldene

20 mg

Capsule, hard

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156 Km 50 |
| I-04010 Borgo San Michele (Lt) |

Pfizer Italia S.r.l.

S.S. 156 Km 50

I-04010 Borgo San Michele (Lt)

Feldene

20 mg

Suppository

Rectal use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156 Km 50 |
| I-04010 Borgo San Michele (Lt) |

Pfizer Italia S.r.l.

S.S. 156 Km 50

I-04010 Borgo San Michele (Lt)

Feldene

20 mg

Soluble tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156 Km 50 |
| I-04010 Borgo San Michele (Lt) |

Pfizer Italia S.r.l.

S.S. 156 Km 50

I-04010 Borgo San Michele (Lt)

Feldene

20 mg/1 ml

Solution for injection

Intramuscular use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156 Km 50 |
| I-04010 Borgo San Michele (Lt) |

Pfizer Italia S.r.l.

S.S. 156 Km 50

I-04010 Borgo San Michele (Lt)

Feldene Cremadol

1 %

Cream

Cutaneous use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156 Km 50 |
| I-04010 Borgo San Michele (Lt) |

Pfizer Italia S.r.l.

S.S. 156 Km 50

I-04010 Borgo San Michele (Lt)

Feldene Fast

20 mg

Tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156 Km 50 |
| I-04010 Borgo San Michele (Lt) |

Pfizer Italia S.r.l.

S.S. 156 Km 50

I-04010 Borgo San Michele (Lt)

Feldene Fast

20 mg

Sublingual tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156 Km 50 |
| I-04010 Borgo San Michele (Lt) |

Pfizer Italia S.r.l.

S.S. 156 Km 50

I-04010 Borgo San Michele (Lt)

Feldene Lipo

1 %

Gel

Cutaneous use

Italy

| Pliva Pharma S.p.A. |
| --- |
| Via Tranquillo Cremona 10 |
| I-20092 Cinisello Balsamo (Mi) |

Pliva Pharma S.p.A.

Via Tranquillo Cremona 10

I-20092 Cinisello Balsamo (Mi)

Roxene

1 %

Cream

Cutaneous use

Italy

| Pliva Pharma S.p.A. |
| --- |
| Via Tranquillo Cremona 10 |
| I-20092 Cinisello Balsamo (Mi) |

Pliva Pharma S.p.A.

Via Tranquillo Cremona 10

I-20092 Cinisello Balsamo (Mi)

Roxene

20 mg/1 ml

Solution for injection

Intramuscular use

Italy

| Pliva Pharma S.p.A. |
| --- |
| Via Tranquillo Cremona 10 |
| I-20092 Cinisello Balsamo (Mi) |

Pliva Pharma S.p.A.

Via Tranquillo Cremona 10

I-20092 Cinisello Balsamo (Mi)

Roxene

20 mg

Soluble tablet

Oral use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Brexin

20 mg

Granules for oral solution

Oral use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Brexin

20 mg

Suppository

Rectal use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Brexin

20 mg

Tablet

Oral use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Brexin

20 mg

Effervescent tablet

Oral use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Brexivel

2 ml

Powder and solvent for solution for injection

Intramuscular use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Brexivel

20 mg

Capsule, hard

Oral use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Brexivel

20 mg

Suppository

Rectal use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Brexivel

1 %

Cream

Cutaneous use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Brexivel

20 mg/1 ml

Solution for injection

Intramuscular use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Riacen

10 mg

Capsule, hard

Oral use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Riacen

20 mg

Capsule, hard

Oral use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Riacen

20 mg

Suppository

Rectal use

Italy

| Promedica S.r.l. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Promedica S.r.l.

Via Palermo 26 A

I-43100 Parma

Riacen

1 %

Cream

Cutaneous use

Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arco Straße 3 |
| D-89070 Ulm |

Ratiopharm GmbH

Graf-Arco Straße 3

D-89070 Ulm

Piroxicam Ratiopharm

20 mg/ml

Solution for injection

Intramuscular use

Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arco Straße 3 |
| D-89070 Ulm |

Ratiopharm GmbH

Graf-Arco Straße 3

D-89070 Ulm

Piroxicam Ratiopharm

20 mg

Capsule, hard

Oral use

Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arco Straße 3 |
| D-89070 Ulm |

Ratiopharm GmbH

Graf-Arco Straße 3

D-89070 Ulm

Piroxicam Ratiopharm

20 mg

Soluble tablet

Oral use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Boccioni 1 |
| I-21040 Origgio (Va) |

Sandoz S.p.A.

Largo Boccioni 1

I-21040 Origgio (Va)

Piroxicam Sandoz

20 mg

Suppository

Rectal use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Boccioni 1 |
| I-21040 Origgio (Va) |

Sandoz S.p.A.

Largo Boccioni 1

I-21040 Origgio (Va)

Piroxicam Sandoz

20 mg

Capsule, hard

Oral use

Italy

| Sandoz S.p.A. |
| --- |
| Largo Boccioni 1 |
| I-21040 Origgio (Va) |

Sandoz S.p.A.

Largo Boccioni 1

I-21040 Origgio (Va)

Piroxicam Sandoz

1 %

Cream

Cutaneous use

Italy

| So.Se.Pharm S.r.l. Società di servizio per l'industria Farmaceutica ed affini |
| --- |
| Via dei Castelli Romani 22 |
| I-00040 Pomezia (Rm) |

So.Se.Pharm S.r.l. Società di servizio per l'industria Farmaceutica ed affini

Via dei Castelli Romani 22

I-00040 Pomezia (Rm)

Artroxicam

20 mg

Capsule

Oral use

Italy

| So.Se.Pharm S.r.l. Società di servizio per l'industria Farmaceutica ed affini |
| --- |
| Via dei Castelli Romani 22 |
| I-00040 Pomezia (Rm) |

So.Se.Pharm S.r.l. Società di servizio per l'industria Farmaceutica ed affini

Via dei Castelli Romani 22

I-00040 Pomezia (Rm)

Artroxicam

20 mg

Suppository

Rectal use

Italy

| So.Se.Pharm S.r.l. Società di servizio per l'industria Farmaceutica ed affini |
| --- |
| Via dei Castelli Romani 22 |
| I-00040 Pomezia (Rm) |

So.Se.Pharm S.r.l. Società di servizio per l'industria Farmaceutica ed affini

Via dei Castelli Romani 22

I-00040 Pomezia (Rm)

Artroxicam

1 %

Cream

Topical use

Italy

| So.Se.Pharm S.r.l. Società di servizio per l'industria Farmaceutica ed affini |
| --- |
| Via dei Castelli Romani 22 |
| I-00040 Pomezia (Rm) |

So.Se.Pharm S.r.l. Società di servizio per l'industria Farmaceutica ed affini

Via dei Castelli Romani 22

I-00040 Pomezia (Rm)

Artroxicam

1 %

Cutaneous foam

Cutaneous use

Italy

| Tad Pharma Italia S.r.l. |
| --- |
| Via Felice Casati 16 |
| I-20124 Milano |

Tad Pharma Italia S.r.l.

Via Felice Casati 16

I-20124 Milano

Errekam

20 mg

Solution for injection

Intramuscular use

Italy

| Teva Pharma Italia S.r.l. |
| --- |
| Viale G. Richard 7 |
| I-20143 Milano |

Teva Pharma Italia S.r.l.

Viale G. Richard 7

I-20143 Milano

Piroxicam

1 %

Cream

Cutaneous use

Italy

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Bodio 37 B |
| I-20158 Milano |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Bodio 37 B

I-20158 Milano

Piroxicam Winthrop

20 mg

Capsule, hard

Oral use

Lithuania

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexin

20 mg

Tablet

Oral use

Lithuania

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexin

20 mg/3 mg

Granules for oral solution

Oral use

Lithuania

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straβe 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Straβe 173

D-55216 Ingelheim am Rhein

Finalgel Sport

0,5 g/100 g

Gel

Cutaneous use

Lithuania

| Egis Pharmaceuticals Ltd |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Ltd

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

20 mg

Capsule

Oral use

Lithuania

| Egis Pharmaceuticals Ltd |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Ltd

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

20 mg/ml

Solution for injection

Intramuscular use

Lithuania

| Egis Pharmaceuticals Ltd |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Ltd

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

500 mg/50 g

Cream

Cutaneous use

Lithuania

| Pharmaceutical Works Jelfa Sa |
| --- |
| ul. W. Pola 21 |
| PL-58-500 Jelenia Gora |

Pharmaceutical Works Jelfa Sa

ul. W. Pola 21

PL-58-500 Jelenia Gora

Piroxicam

20 mg

Coated tablet

Oral use

Lithuania

| Pharmaceutical Works Jelfa Sa |
| --- |
| ul. W. Pola 21 |
| PL-58-500 Jelenia Gora |

Pharmaceutical Works Jelfa Sa

ul. W. Pola 21

PL-58-500 Jelenia Gora

Piroxicam

10 mg

Coated tablet

Oral use

Luxembourg

| Pfizer S.A. |
| --- |
| 17 Boulevards de la Plaine |
| B-1050 Bruxelless |

Pfizer S.A.

17 Boulevards de la Plaine

B-1050 Bruxelless

Feldene

20 mg

Tablet

Oral use

Luxembourg

| Pfizer S.A. |
| --- |
| 17 Boulevards de la Plaine |
| B-1050 Bruxelless |

Pfizer S.A.

17 Boulevards de la Plaine

B-1050 Bruxelless

Feldene

10 mg

Capsule

Oral use

Luxembourg

| Pfizer S.A. |
| --- |
| 17 Boulevards de la Plaine |
| B-1050 Bruxelless |

Pfizer S.A.

17 Boulevards de la Plaine

B-1050 Bruxelless

Feldene

20 mg

Capsule

Oral use

Luxembourg

| Pfizer S.A. |
| --- |
| 17 Boulevards de la Plaine |
| B-1050 Bruxelless |

Pfizer S.A.

17 Boulevards de la Plaine

B-1050 Bruxelless

Feldene

20 mg

Suppository

Rectal use

Luxembourg

| Pfizer S.A. |
| --- |
| 17 Boulevards de la Plaine |
| B-1050 Bruxelless |

Pfizer S.A.

17 Boulevards de la Plaine

B-1050 Bruxelless

Feldene

20 mg/ml

Solution for injection

Intramuscular use

Luxembourg

| Pfizer S.A. |
| --- |
| 17 Boulevards de la Plaine |
| B-1050 Bruxelless |

Pfizer S.A.

17 Boulevards de la Plaine

B-1050 Bruxelless

Feldene Dispersal

20 mg

Dispersible tablet

Oral use

Luxembourg

| Eurogenerics S.A. |
| --- |
| Esplanade Heysel, B 22 |
| B-1020 Bruxelless |

Eurogenerics S.A.

Esplanade Heysel, B 22

B-1020 Bruxelless

Lampoflex

10 mg

Capsule

Oral use

Luxembourg

| Eurogenerics S.A. |
| --- |
| Esplanade Heysel B 22 |
| B-1020 Bruxelless |

Eurogenerics S.A.

Esplanade Heysel B 22

B-1020 Bruxelless

Lampoflex

20 mg

Capsule

Oral use

Luxembourg

| Eurogenerics S.A. |
| --- |
| Esplanade Heysel B 22 |
| B-1020 Bruxelless |

Eurogenerics S.A.

Esplanade Heysel B 22

B-1020 Bruxelless

Lampoflex

0,50 %

Gel

Cutaneous use

Luxembourg

| Nycomed Belgium S.A. |
| --- |
| 615 Chaussée de Gand |
| B-1080 Bruxelless |

Nycomed Belgium S.A.

615 Chaussée de Gand

B-1080 Bruxelless

Brexine

20 mg

Tablet

Oral use

Luxembourg

| Nycomed Belgium S.A. |
| --- |
| 615 Chaussée de Gand |
| B-1080 Bruxelless |

Nycomed Belgium S.A.

615 Chaussée de Gand

B-1080 Bruxelless

Brexine

20 mg

Granules

Oral use

Luxembourg

| Nycomed Belgium S.A. |
| --- |
| 615 Chaussée de Gand |
| B-1080 Bruxelless |

Nycomed Belgium S.A.

615 Chaussée de Gand

B-1080 Bruxelless

Brexine

10 mg

Tablet

Oral use

Luxembourg

| Nycomed Belgium S.A. |
| --- |
| 615 Chaussée de Gand |
| B-1080 Bruxelless |

Nycomed Belgium S.A.

615 Chaussée de Gand

B-1080 Bruxelless

Brexine

20 mg

Effervescent tablet

Oral use

Luxembourg

| Smb Laboratories |
| --- |
| 26-28 Rue de la Pastorale |
| B-1080 Bruxelless |

Smb Laboratories

26-28 Rue de la Pastorale

B-1080 Bruxelless

Solicam

10 mg

Capsule

Oral use

Luxembourg

| Smb Laboratories |
| --- |
| 26-28 Rue de la Pastorale |
| B-1080 Bruxelless |

Smb Laboratories

26-28 Rue de la Pastorale

B-1080 Bruxelless

Solicam

20 mg

Capsule

Oral use

Luxembourg

| Docpharma S.A. |
| --- |
| Ambachtenlaan 13h |
| B-3001 Heverlee |

Docpharma S.A.

Ambachtenlaan 13h

B-3001 Heverlee

Docpiroxi Dispers

20 mg

Dispersible tablet

Oral use

Luxembourg

| Rationpharm GmbH |
| --- |
| Postfach 3380 |
| D-89070 Ulm |

Rationpharm GmbH

Postfach 3380

D-89070 Ulm

Piroxicam-Rpm

10 mg

Tablet

Oral use

Luxembourg

| Rationpharm GmbH |
| --- |
| Postfach 3380 |
| D-89070 Ulm |

Rationpharm GmbH

Postfach 3380

D-89070 Ulm

Piroxicam-Rpm

20 mg

Tablet

Oral use

Luxembourg

| Hexal AG |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

Hexal AG

Industriestraße 25

D-83607 Holzkirchen

Piroxicam-HEXAL

10 mg

Tablet

Oral use

Luxembourg

| Hexal Ag |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

Hexal Ag

Industriestraße 25

D-83607 Holzkirchen

Piroxicam-Hexal

20 mg

Tablet

Oral use

Latvia

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexin

20 mg

Granules

Oral use

Latvia

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Brexin

20 mg

Tablet

Oral use

Latvia

| Cipla (Uk) Limited |
| --- |
| 53a High Street Esher |
| Surrey KT10 9QR |
| United Kingdom |

Cipla (Uk) Limited

53a High Street Esher

Surrey KT10 9QR

United Kingdom

Pirox Gel

0,5 %

Gel

Dermal use

Latvia

| Cipla (Uk) Limited |
| --- |
| 53a High Street Esher |
| Surrey KT10 9QR |
| United Kingdom |

Cipla (Uk) Limited

53a High Street Esher

Surrey KT10 9QR

United Kingdom

Pirox-20

20 mg

Capsule

Oral use

Latvia

| Sopharma Ad |
| --- |
| Iliensko Shose Str. 16 |
| BG-1220 Sofia |

Sopharma Ad

Iliensko Shose Str. 16

BG-1220 Sofia

Piroxicam

10 mg

Capsule

Oral use

Latvia

| Sopharma Ad |
| --- |
| Iliensko Shose Str. 16 |
| BG-1220 Sofia |

Sopharma Ad

Iliensko Shose Str. 16

BG-1220 Sofia

Piroxicam

20 mg

Capsule

Oral use

Latvia

| Pharmaceutical Works Jelfa S.A. |
| --- |
| ul. Wincentego Pola 21 |
| PL-58-500 Jelenia Gora |

Pharmaceutical Works Jelfa S.A.

ul. Wincentego Pola 21

PL-58-500 Jelenia Gora

Piroxicam 10 mg

10 mg

Film-coated tablet

Oral use

Latvia

| Pharmaceutical Works Jelfa S.A. |
| --- |
| ul. Wincentego Pola 21 |
| PL-58-500 Jelenia Gora |

Pharmaceutical Works Jelfa S.A.

ul. Wincentego Pola 21

PL-58-500 Jelenia Gora

Piroxicam 20 mg

20 mg

Film-coated tablet

Oral use

Latvia

| Tallinna Farmaatsiatehase AS |
| --- |
| Tondi 33 |
| EE-11316 Tallinn |

Tallinna Farmaatsiatehase AS

Tondi 33

EE-11316 Tallinn

Piroxicam Tft

20 mg

Tablet

Oral use

Malta

| Bruschettini S.r.l. |
| --- |
| Via Isonzo 4 |
| I-16147 Genova |

Bruschettini S.r.l.

Via Isonzo 4

I-16147 Genova

Bruxicam

1 g

Cream

Topical use

Malta

| Bruschettini S.r.l. |
| --- |
| Via Isonzo 4 |
| I-16147 Genova |

Bruschettini S.r.l.

Via Isonzo 4

I-16147 Genova

Bruxicam

20 mg

Capsule

Oral use

Malta

| Alta Care Laboratories Ltd |
| --- |
| Via Ilderbrando Vivanti 188 |
| I-00144 Roma |

Alta Care Laboratories Ltd

Via Ilderbrando Vivanti 188

I-00144 Roma

Flodol

1 g

Gel

Topical use

Malta

| Alta Care Laboratories Ltd |
| --- |
| Via Ilderbrando Vivanti 188 |
| I-00144 Roma |

Alta Care Laboratories Ltd

Via Ilderbrando Vivanti 188

I-00144 Roma

Flodol

20 mg

Capsule

Oral use

The Netherlands

| Actavis B.V. |
| --- |
| Postbus 313 |
| 3740 AH Baarn |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| Nederland |

Actavis B.V.

Postbus 313

3740 AH Baarn

Baarnsche Dijk 1

3741 LN Baarn

Nederland

Piroxicam Actavis Disper 20 mg

20 mg

Dispersible tablet

Oral use

The Netherlands

| Actavis B.V. |
| --- |
| Postbus 313 |
| 3740 AH Baarn |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| Nederland |

Actavis B.V.

Postbus 313

3740 AH Baarn

Baarnsche Dijk 1

3741 LN Baarn

Nederland

Piroxicam Actavis 10 mg

10 mg

Capsule

Oral use

The Netherlands

| Actavis B.V. |
| --- |
| Postbus 313 |
| 3740 AH Baarn |
| Baarnsche Dijk 1 |
| 3741 LN Baarn |
| Nederland |

Actavis B.V.

Postbus 313

3740 AH Baarn

Baarnsche Dijk 1

3741 LN Baarn

Nederland

Piroxicam Actavis 20 mg

20 mg

Capsule

Oral use

The Netherlands

| Centrafarm Services B.V. |
| --- |
| Postbus 289 |
| 4870 AG Etten Leur |
| Nederland |

Centrafarm Services B.V.

Postbus 289

4870 AG Etten Leur

Nederland

Piroxicam Cf 10 mg

10 mg

Capsule

Oral use

The Netherlands

| Centrafarm Services B.V. |
| --- |
| Postbus 289 |
| 4870 AG Etten Leur |
| Nederland |

Centrafarm Services B.V.

Postbus 289

4870 AG Etten Leur

Nederland

Piroxicam Cf 20 mg

20 mg

Capsule

Oral use

The Netherlands

| Centrafarm Services B.V. |
| --- |
| Postbus 289 |
| 4870 AG Etten Leur |
| Nederland |

Centrafarm Services B.V.

Postbus 289

4870 AG Etten Leur

Nederland

Piroxicam Disper Cf 20 mg

20 mg

Dispersible tablet

Oral use

The Netherlands

| Sandoz B.V |
| --- |
| Veluwezoon 22 |
| 1327 AH Almere |
| Nederland |

Sandoz B.V

Veluwezoon 22

1327 AH Almere

Nederland

Piroxicam Sandoz Disper 10 mg

10 mg

Dispersible tablet

Oral use

The Netherlands

| Sandoz B.V |
| --- |
| Veluwezoon 22 |
| 1327 AH Almere |
| Nederland |

Sandoz B.V

Veluwezoon 22

1327 AH Almere

Nederland

Piroxicam Sandoz Disper 20 mg

20 mg

Dispersible tablet

Oral use

The Netherlands

| Sandoz B.V |
| --- |
| Veluwezoon 22 |
| 1327 AH Almere |
| Nederland |

Sandoz B.V

Veluwezoon 22

1327 AH Almere

Nederland

Piroxicam Sandoz 20 mg Zetpil

20 mg

Suppository

Rectal use

The Netherlands

| Karib Ltd, |
| --- |
| Karib House |
| 63-65 Imperial Way |
| CR9 4QY Croydon Surrey |
| United Kingdom |

Karib Ltd,

Karib House

63-65 Imperial Way

CR9 4QY Croydon Surrey

United Kingdom

Piroxicam Flx 10 mg

10 mg

Capsule

Oral use

The Netherlands

| Karib Ltd, |
| --- |
| Karib House |
| 63-65 Imperial Way |
| CR9 4QY Croydon Surrey |
| United Kingdom |

Karib Ltd,

Karib House

63-65 Imperial Way

CR9 4QY Croydon Surrey

United Kingdom

Piroxicam Flx 20 mg,

20 mg

Capsule

Oral use

The Netherlands

| Katwijk Farma B.V. |
| --- |
| Postbus 408 |
| 2300 AK Leiden |
| Nederland |

Katwijk Farma B.V.

Postbus 408

2300 AK Leiden

Nederland

Piroxicam Katwijk 20 mg Dispers Tabletten

20 mg

Dispersible tablet

Oral use

The Netherlands

| Nycomed Nederland B.V. |
| --- |
| Nikkelstraat 5 |
| 4823 AE Breda |
| Nederland |

Nycomed Nederland B.V.

Nikkelstraat 5

4823 AE Breda

Nederland

Brexine Bruis

20 mg

Effervescent tablet

Oral use

The Netherlands

| Nycomed Nederland B.V. |
| --- |
| Nikkelstraat 5 |
| 4823 AE Breda |
| Nederland |

Nycomed Nederland B.V.

Nikkelstraat 5

4823 AE Breda

Nederland

Brexine

20 mg

Oral powder

Oral use

The Netherlands

| Nycomed Nederland B.V. |
| --- |
| Nikkelstraat 5 |
| 4823 AE Breda |
| Nederland |

Nycomed Nederland B.V.

Nikkelstraat 5

4823 AE Breda

Nederland

Brexine

20 mg

Tablet

Oral use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Postbus 552 |
| 2003 RN Haarlem |
| Nederland |

Pharmachemie B.V.

Postbus 552

2003 RN Haarlem

Nederland

Piroxicam Disp. 10 PCH

10 mg

Dispersible tablet

Oral use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Postbus 552 |
| 2003 RN Haarlem |
| Nederland |

Pharmachemie B.V.

Postbus 552

2003 RN Haarlem

Nederland

Piroxicam Disp. 20 PCH

20 mg

Dispersible tablet

Oral use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Postbus 552 |
| 2003 RN Haarlem |
| Nederland |

Pharmachemie B.V.

Postbus 552

2003 RN Haarlem

Nederland

Piroxicam 10 PCH

10 mg

Capsule

Oral use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Postbus 552 |
| 2003 RN Haarlem |
| Nederland |

Pharmachemie B.V.

Postbus 552

2003 RN Haarlem

Nederland

Piroxicam 20 PCH

20 mg

Capsule

Oral use

The Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Postbus 2062 |
| 1500 GB Zaandam |
| Nederland |

Ratiopharm Nederland B.V.

Postbus 2062

1500 GB Zaandam

Nederland

Piroxicam Ratiopharm Dispergeerbaar 20 mg

20 mg

Dispersible tablet

Oral use

The Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Postbus 2062 |
| 1500 GB Zaandam |
| Nederland |

Ratiopharm Nederland B.V.

Postbus 2062

1500 GB Zaandam

Nederland

Piroxicam Ratiopharm 10 mg

10 mg

Capsule

Oral use

The Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Postbus 2062 |
| 1500 GB Zaandam |
| Nederland |

Ratiopharm Nederland B.V.

Postbus 2062

1500 GB Zaandam

Nederland

Piroxicam Ratiopharm 10 mg

10 mg

Capsule

Oral use

The Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Postbus 2062 |
| 1500 GB Zaandam |
| Nederland |

Ratiopharm Nederland B.V.

Postbus 2062

1500 GB Zaandam

Nederland

Piroxicam Ratiopharm 20 mg

20 mg

Capsule

Oral use

The Netherlands

| Ratiopharm Nederland B.V. |
| --- |
| Postbus 2062 |
| 1500 GB Zaandam |
| Nederland |

Ratiopharm Nederland B.V.

Postbus 2062

1500 GB Zaandam

Nederland

Piroxicam Ratiopharm 20 mg

20 mg

Capsule

Oral use

The Netherlands

| Sanofi-Synthelabo B.V. |
| --- |
| Postbus 2043 |
| 2800 BD Gouda |
| Nederland |

Sanofi-Synthelabo B.V.

Postbus 2043

2800 BD Gouda

Nederland

Piroxicam Albic 10 mg

10 mg

Capsule

Oral use

The Netherlands

| Sanofi-Synthelabo B.V. |
| --- |
| Postbus 2043 |
| 2800 BD Gouda |
| Nederland |

Sanofi-Synthelabo B.V.

Postbus 2043

2800 BD Gouda

Nederland

Piroxicam Albic 20 mg

20 mg

Capsule

Oral use

The Netherlands

| Wise Pharmaceuticals Ltd |
| --- |
| Hamwells Business Park |
| Unit No.7 Hardicker Street |
| M19 2RB Manchester |
| United Kingdom |

Wise Pharmaceuticals Ltd

Hamwells Business Park

Unit No.7 Hardicker Street

M19 2RB Manchester

United Kingdom

Piroxicam 10 mg

10 mg

Capsule

Oral use

The Netherlands

| Wise Pharmaceuticals Ltd |
| --- |
| Hamwells Business Park |
| Unit No.7 Hardicker Street |
| M19 2RB Manchester |
| United Kingdom |

Wise Pharmaceuticals Ltd

Hamwells Business Park

Unit No.7 Hardicker Street

M19 2RB Manchester

United Kingdom

Piroxicam 20 mg

20 mg

Capsule

Oral use

Norway

| Pfizer |
| --- |
| PO Box 3 |
| N-1324 Lysaker |

Pfizer

PO Box 3

N-1324 Lysaker

Felden

20 mg

Tablet

Oral use

Norway

| Nycomed Pharma As |
| --- |
| P.O. Box 205 N-1372 Asker |
| N-0010 Oslo |

Nycomed Pharma As

P.O. Box 205 N-1372 Asker

N-0010 Oslo

Brexidol

20 mg

Tablet

Oral use

Norway

| Nycomed Pharma As |
| --- |
| P.O. Box 205 N-1372 Asker |
| N-0010 Oslo |

Nycomed Pharma As

P.O. Box 205 N-1372 Asker

N-0010 Oslo

Brexidol

20 mg

Oral powder in sachet

Oral use

Norway

| Alpharma |
| --- |
| P.O. Box |
| 158 Skøyen |
| N-0212 Oslo |

Alpharma

P.O. Box

158 Skøyen

N-0212 Oslo

Pirox

20 mg

Tablet

Oral use

Norway

| Merck NM |
| --- |
| P.O.Box 23033 |
| S-10435 Stockholm |

Merck NM

P.O.Box 23033

S-10435 Stockholm

Piroxicam Merck Nm

20 mg

Tablet

Oral use

Poland

| Apotex Europe Ltd |
| --- |
| Rowan House |
| 41 London Street |
| Reading Berkshire RG1 4PS |
| United Kingdom |

Apotex Europe Ltd

Rowan House

41 London Street

Reading Berkshire RG1 4PS

United Kingdom

Apo-Piroxicam 10

10 mg

Capsule

Oral use

Poland

| Apotex Europe Ltd |
| --- |
| Rowan House |
| 41 London Street |
| Reading Berkshire RG1 4PS |
| United Kingdom |

Apotex Europe Ltd

Rowan House

41 London Street

Reading Berkshire RG1 4PS

United Kingdom

Apo-Piroxicam 20

20 mg

Capsule

Oral use

Poland

| Pfizer Europe MA EEIG |
| --- |
| Sandwich |
| Kent Ct13 9nj |
| United Kingdom |

Pfizer Europe MA EEIG

Sandwich

Kent Ct13 9nj

United Kingdom

Feldene

20 mg/ml

Solution for injection

Parenteral use

Poland

| Glaxosmithkline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka St. 189 |
| PL-60-322 Poznań |

Glaxosmithkline Pharmaceuticals S.A.

Grunwaldzka St. 189

PL-60-322 Poznań

Piroxicam 10

10 mg

Suppository

Rectal use

Poland

| Glaxosmithkline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka St. 189 |
| PL-60-322 Poznań |

Glaxosmithkline Pharmaceuticals S.A.

Grunwaldzka St. 189

PL-60-322 Poznań

Piroxicam 20

20 mg

Suppository

Rectal use

Poland

| Glaxosmithkline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka St. 189 |
| PL-60-322 Poznań |

Glaxosmithkline Pharmaceuticals S.A.

Grunwaldzka St. 189

PL-60-322 Poznań

Piroxicam

50 mg/g

Ointment

Cutaneous use

Poland

| Glaxosmithkline Pharmaceuticals S.A. |
| --- |
| Grunwaldzka St. 189 |
| PL-60-322 Poznań |

Glaxosmithkline Pharmaceuticals S.A.

Grunwaldzka St. 189

PL-60-322 Poznań

Piroxicam

50 mg/g

Gel

Cutaneous use

Poland

| Przedsiębiorstwo Farmaceutyczne Jelfa S.A. |
| --- |
| Wincentego St. Pola 21 |
| PL-58-500 Jelenia Góra |

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.

Wincentego St. Pola 21

PL-58-500 Jelenia Góra

Piroxicam Jelfa

10 mg

Film-coated tablet

Oral use

Poland

| Przedsiębiorstwo Farmaceutyczne Jelfa S.A. |
| --- |
| Wincentego St. Pola 21 |
| PL-58-500 Jelenia Góra |

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.

Wincentego St. Pola 21

PL-58-500 Jelenia Góra

Piroxicam Jelfa

20 mg

Film-coated tablet

Oral use

Poland

| Egis Pharmaceuticals Ltd |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Ltd

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

10 mg

Capsule

Oral use

Poland

| Egis Pharmaceuticals Ltd |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Ltd

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

20 mg

Capsule, hard

Oral use

Poland

| Egis Pharmaceuticals Ltd |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Ltd

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

20 mg/ml

Solution for injection

Parenteral use

Poland

| Torrex Chiesi Polska Sp. z o.o. |
| --- |
| ul. Biala 3 |
| PL-00-895 Warszawa |

Torrex Chiesi Polska Sp. z o.o.

ul. Biala 3

PL-00-895 Warszawa

Flamexin

20 mg

Powder for solution for injection

Parenteral use

Poland

| Torrex Chiesi Polska Sp. z o.o. |
| --- |
| ul. Biala 3 |
| PL-00-895 Warszawa |

Torrex Chiesi Polska Sp. z o.o.

ul. Biala 3

PL-00-895 Warszawa

Flamexin

20 mg

Tablet

Oral use

Poland

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Str. 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Str. 173

D-55216 Ingelheim am Rhein

Finalgel Sport

5 mg/g

Gel

Cutaneous use

Poland

| Sankyo Pharma GmbH |
| --- |
| Zielstattstr. 48 |
| D-81379 München |

Sankyo Pharma GmbH

Zielstattstr. 48

D-81379 München

Mobilat P Crème

5 mg/g

Cream

Cutaneous use

Portugal

| Neo-Farmacêutica Lda |
| --- |
| Av. D. João II |
| Lote 1.02.2.1 D-2o |
| P-1990-090 Lisboa |

Neo-Farmacêutica Lda

Av. D. João II

Lote 1.02.2.1 D-2o

P-1990-090 Lisboa

Brexin

20 mg

Tablet

Oral use

Portugal

| Neo-Farmacêutica Lda |
| --- |
| Av. D. João II |
| Lote 1.02.2.1 D-2o |
| P-1990-090 Lisboa |

Neo-Farmacêutica Lda

Av. D. João II

Lote 1.02.2.1 D-2o

P-1990-090 Lisboa

Brexin

20 mg

Effervescent tablet

Oral use

Portugal

| Neo-Farmacêutica Lda |
| --- |
| Av. D. João II |
| Lote 1.02.2.1 D-2o |
| P-1990-090 Lisboa |

Neo-Farmacêutica Lda

Av. D. João II

Lote 1.02.2.1 D-2o

P-1990-090 Lisboa

Brexin

20 mg

Granules

Oral use

Portugal

| Laboratórios Pfizer Lda |
| --- |
| Empreendimento Lagoas Park |
| Edifício 10 |
| P-2740-271 Porto Salvo |

Laboratórios Pfizer Lda

Empreendimento Lagoas Park

Edifício 10

P-2740-271 Porto Salvo

Feldene

20 mg

Capsule

Oral use

Portugal

| Laboratórios Pfizer Lda |
| --- |
| Empreendimento Lagoas Park |
| Edifício 10 |
| P-2740-271 Porto Salvo |

Laboratórios Pfizer Lda

Empreendimento Lagoas Park

Edifício 10

P-2740-271 Porto Salvo

Feldene

20 mg

Dispersible tablet

Oral use

Portugal

| Laboratórios Pfizer Lda |
| --- |
| Empreendimento Lagoas Park |
| Edifício 10 |
| P-2740-271 Porto Salvo |

Laboratórios Pfizer Lda

Empreendimento Lagoas Park

Edifício 10

P-2740-271 Porto Salvo

Feldene

5 mg/g

Gel

Cutaneous use

Portugal

| Laboratórios Pfizer Lda |
| --- |
| Empreendimento Lagoas Park |
| Edifício 10 |
| P-2740-271 Porto Salvo |

Laboratórios Pfizer Lda

Empreendimento Lagoas Park

Edifício 10

P-2740-271 Porto Salvo

Feldene

20 mg/1 ml

Solution for injection

Intramuscular use

Portugal

| Laboratórios Pfizer Lda |
| --- |
| Empreendimento Lagoas Park |
| Edifício 10 |
| P-2740-271 Porto Salvo |

Laboratórios Pfizer Lda

Empreendimento Lagoas Park

Edifício 10

P-2740-271 Porto Salvo

Feldene

20 mg

Suppository

Rectal use

Portugal

| A. Menarini Portugal |
| --- |
| Farmacêutica S.A. Quinta Da Fonte |
| Edifício D. Manuel I |
| Piso 2 |
| Rua dos Malhões n.o 1 |
| P-2770-071 Paço De Arcos |

A. Menarini Portugal

Farmacêutica S.A. Quinta Da Fonte

Edifício D. Manuel I

Piso 2

Rua dos Malhões n.o 1

P-2770-071 Paço De Arcos

Flexar

20 mg

Capsule

Oral use

Portugal

| A. Menarini Portugal |
| --- |
| Farmacêutica S.A. Quinta Da Fonte |
| Edifício D. Manuel I |
| Piso 2 |
| Rua dos Malhões n.o 1 |
| P-2770-071 Paço De Arcos |

A. Menarini Portugal

Farmacêutica S.A. Quinta Da Fonte

Edifício D. Manuel I

Piso 2

Rua dos Malhões n.o 1

P-2770-071 Paço De Arcos

Flexar

20 mg

Dispersible tablet

Oral use

Portugal

| A. Menarini Portugal |
| --- |
| Farmacêutica S.A. Quinta Da Fonte |
| Edifício D. Manuel I |
| Piso 2 |
| Rua dos Malhões n.o 1 |
| P-2770-071 Paço De Arcos |

A. Menarini Portugal

Farmacêutica S.A. Quinta Da Fonte

Edifício D. Manuel I

Piso 2

Rua dos Malhões n.o 1

P-2770-071 Paço De Arcos

Flexar

5 mg/g

Gel

Cutaneous use

Portugal

| A. Menarini Portugal |
| --- |
| Farmacêutica S.A. Quinta Da Fonte |
| Edifício D. Manuel I |
| Piso 2 |
| Rua dos Malhões n.o 1 |
| P-2770-071 Paço De Arcos |

A. Menarini Portugal

Farmacêutica S.A. Quinta Da Fonte

Edifício D. Manuel I

Piso 2

Rua dos Malhões n.o 1

P-2770-071 Paço De Arcos

Flexar

20 mg

Suppository

Rectal use

Portugal

| A. Menarini Portugal |
| --- |
| Farmacêutica S.A. |
| Rua General Ferreira Martins 8 |
| 7.o Miraflores |
| P-1495-137 Algés |

A. Menarini Portugal

Farmacêutica S.A.

Rua General Ferreira Martins 8

7.o Miraflores

P-1495-137 Algés

Flexar

20 mg/1 ml

Solution for injection

Intramuscular use

Portugal

| Laboratórios Azevedos — Indústria Farmacêutica S.A. |
| --- |
| Estrada Nacional 117-2 |
| Edifícios Azevedos — Alfragide |
| P-2724-503 Amadora |

Laboratórios Azevedos — Indústria Farmacêutica S.A.

Estrada Nacional 117-2

Edifícios Azevedos — Alfragide

P-2724-503 Amadora

Flogocan 10

10 mg

Capsule

Oral use

Portugal

| Laboratórios Azevedos |
| --- |
| Indústria Farmacêutica S.A. |
| Estrada Nacional 117-2 |
| Edifícios Azevedos |
| Alfragide |
| P-2724-503 Amadora |

Laboratórios Azevedos

Indústria Farmacêutica S.A.

Estrada Nacional 117-2

Edifícios Azevedos

Alfragide

P-2724-503 Amadora

Flogocan 20

20 mg

Capsule

Oral use

Portugal

| Ratiopharm |
| --- |
| Comércio E Indústria De Produtos Farmacêuticos Lda |
| Rua Quinta Do Pinheiro |
| Edifício Tejo |
| 6.o Piso |
| P-2790-143 Carnaxide |

Ratiopharm

Comércio E Indústria De Produtos Farmacêuticos Lda

Rua Quinta Do Pinheiro

Edifício Tejo

6.o Piso

P-2790-143 Carnaxide

Piroxicam Ratiopharm 10 mg Comprimidos

10 mg

Tablet

Oral use

Portugal

| Ratiopharm |
| --- |
| Comércio E Indústria De Produtos Farmacêuticos Lda |
| Rua Quinta Do Pinheiro |
| Edifício Tejo |
| 6.o Piso |
| P-2790-143 Carnaxide |

Ratiopharm

Comércio E Indústria De Produtos Farmacêuticos Lda

Rua Quinta Do Pinheiro

Edifício Tejo

6.o Piso

P-2790-143 Carnaxide

Piroxicam Ratiopharm 20 mg Comprimidos

20 mg

Tablet

Oral use

Portugal

| Laboratório Medinfar |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua Manuel Ribeiro De Pavia 1 |
| 1.o Venda Nova |
| P-2700-547 Amadora |

Laboratório Medinfar

Produtos Farmacêuticos S.A.

Rua Manuel Ribeiro De Pavia 1

1.o Venda Nova

P-2700-547 Amadora

Reumoxican

10 mg

Capsule

Oral use

Portugal

| Laboratório Medinfar |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua Manuel Ribeiro De Pavia 1 |
| 1.o Venda Nova |
| P-2700-547 Amadora |

Laboratório Medinfar

Produtos Farmacêuticos S.A.

Rua Manuel Ribeiro De Pavia 1

1.o Venda Nova

P-2700-547 Amadora

Reumoxican

20 mg

Capsule

Oral use

Portugal

| Laboratório Medinfar |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua Manuel Ribeiro De Pavia 1 |
| 1.o Venda Nova |
| P-2700-547 Amadora |

Laboratório Medinfar

Produtos Farmacêuticos S.A.

Rua Manuel Ribeiro De Pavia 1

1.o Venda Nova

P-2700-547 Amadora

Reumoxican

10 mg

Dispersible tablet

Oral use

Portugal

| Laboratório Medinfar |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua Manuel Ribeiro De Pavia 1 |
| 1.o Venda Nova |
| P-2700-547 Amadora |

Laboratório Medinfar

Produtos Farmacêuticos S.A.

Rua Manuel Ribeiro De Pavia 1

1.o Venda Nova

P-2700-547 Amadora

Reumoxican

20 mg

Dispersible tablet

Oral use

Portugal

| Laboratório Medinfar |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua Manuel Ribeiro De Pavia 1 |
| 1.o Venda Nova |
| P-2700-547 Amadora |

Laboratório Medinfar

Produtos Farmacêuticos S.A.

Rua Manuel Ribeiro De Pavia 1

1.o Venda Nova

P-2700-547 Amadora

Reumoxican

10 mg/g

Cream

Cutaneous use

Portugal

| Biosaúde |
| --- |
| Produtos Farmacêuticos Lda |
| Av. José Malhoa |
| Edifício Malhoa Plaza n.o 2 |
| Piso-Escritório 2.2 |
| P-1070-325 Lisboa |

Biosaúde

Produtos Farmacêuticos Lda

Av. José Malhoa

Edifício Malhoa Plaza n.o 2

Piso-Escritório 2.2

P-1070-325 Lisboa

Remisil

5 mg/g

Gel

Cutaneous use

Portugal

| Laboratório Medinfar |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua Manuel Ribeiro De Pavia 1 |
| 1.o Venda Nova |
| P-2700-547 Amadora |

Laboratório Medinfar

Produtos Farmacêuticos S.A.

Rua Manuel Ribeiro De Pavia 1

1.o Venda Nova

P-2700-547 Amadora

Reumoxican

20 mg/1 ml

Solution for injection

Intramuscular use

Portugal

| Laboratório Medinfar |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua Manuel Ribeiro De Pavia 1 |
| 1.o Venda Nova |
| P-2700-547 Amadora |

Laboratório Medinfar

Produtos Farmacêuticos S.A.

Rua Manuel Ribeiro De Pavia 1

1.o Venda Nova

P-2700-547 Amadora

Reumoxican

20 mg

Suppository

Rectal use

Portugal

| Laboratórios Basi |
| --- |
| Indústria Farmacêutica S.A. |
| Rua Do Padrão 98 |
| P-3000-312 Coimbra |

Laboratórios Basi

Indústria Farmacêutica S.A.

Rua Do Padrão 98

P-3000-312 Coimbra

Roxazin

20 mg

Capsule

Oral use

Portugal

| Laboratório Medinfar |
| --- |
| Produtos Farmacêuticos S.A. |
| Rua Manuel Ribeiro De Pavia 1 |
| 1.o Venda Nova |
| P-2700-547 Amadora |

Laboratório Medinfar

Produtos Farmacêuticos S.A.

Rua Manuel Ribeiro De Pavia 1

1.o Venda Nova

P-2700-547 Amadora

Reumoxican S.A.

20 mg

Capsule

Oral use

Portugal

| Cinfa Portugal Lda |
| --- |
| Av. Tomás Ribeiro 43 |
| Bloco 2 3.o F |
| Edifício Neopark |
| P-2790-221 Carnaxide |

Cinfa Portugal Lda

Av. Tomás Ribeiro 43

Bloco 2 3.o F

Edifício Neopark

P-2790-221 Carnaxide

Piroxicam Cinfa 20 mg Comprimidos Dispersíveis

20 mg

Dispersible tablet

Oral use

Romania

| Bruschettini S.r.l. |
| --- |
| Via Isonzo 6 |
| I-16147 Genova |

Bruschettini S.r.l.

Via Isonzo 6

I-16147 Genova

Bruxicam 0,5 %

0,50 %

Eye drops, solution

Ocular use

Romania

| Egis Pharmaceuticals Plc |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Pharmaceuticals Plc

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

20 mg/ml — 1 ml

Solution for injection

Intramuscular use

Romania

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9 NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent CT 13 9 NJ

United Kingdom

FELDENE 20 mg/ml

20 mg/ml — 1 ml

Solution for injection

Intramuscular use

Romania

| Boehringer Ingelheim Pharma GmbH & Co.Kg, |
| --- |
| Binger Straße 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim Pharma GmbH & Co.Kg,

Binger Straße 173

D-55216 Ingelheim am Rhein

Finalgel

5 mg/G

Gel

Cutaneous use

Romania

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin

20 mg

Tablet

Oral use

Romania

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin

20 mg

Effervescent tablet

Oral use

Romania

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin

20 mg

Powder for oral solution

Oral use

Romania

| S.C. Slavia Pharm S.r.l. |
| --- |
| Str. Stirbei Vodă Nr. 53-55 |
| Sector 1, Bucureşti |
| România |

S.C. Slavia Pharm S.r.l.

Str. Stirbei Vodă Nr. 53-55

Sector 1, Bucureşti

România

Piroxsal Gel 0,5 g %

0,5 g %

Gel

Cutaneous use

Romania

| S.C. Meduman S.A. |
| --- |
| Aleea Eroilor Nr. 28 |
| Vişeu De Sus |
| Jud. Maramureş |
| România |

S.C. Meduman S.A.

Aleea Eroilor Nr. 28

Vişeu De Sus

Jud. Maramureş

România

N-Piroxicam 20 mg

20 mg

Tablet

Oral use

Romania

| S.C. Antibiotice S.A. |
| --- |
| Str. Valea Lupului Nr. 1 |
| Iaşi |
| România |

S.C. Antibiotice S.A.

Str. Valea Lupului Nr. 1

Iaşi

România

Piroxicam

3 %

Cream

Local use

Romania

| S.C. Laropharm S.r.l. |
| --- |
| Şos. Alexandriei 145a |
| Comuna Bragadiru |
| Jud. Ilfov |
| România |

S.C. Laropharm S.r.l.

Şos. Alexandriei 145a

Comuna Bragadiru

Jud. Ilfov

România

Piroxicam

20 mg

Tablet

Oral use

Romania

| S.C. Antibiotice S.A. |
| --- |
| Str. Valea Lupului Nr. 1 |
| Iaşi |
| România |

S.C. Antibiotice S.A.

Str. Valea Lupului Nr. 1

Iaşi

România

Piroxicam

0,50 %

Gel

Cutaneous use

Romania

| S.C. Antibiotice S.A. |
| --- |
| Str. Valea Lupului Nr. 1 |
| Iaşi |
| România |

S.C. Antibiotice S.A.

Str. Valea Lupului Nr. 1

Iaşi

România

Piroxicam 20 mg

20 mg

Suppository

Rectal use

Romania

| S.C. Sintofarm S.A. |
| --- |
| Str. Ziduri Între Vii Nr. 22 |
| Sector 2, Bucureşti |
| România |

S.C. Sintofarm S.A.

Str. Ziduri Între Vii Nr. 22

Sector 2, Bucureşti

România

Piroxicam 20 mg

20 mg

Suppository

Rectal use

Romania

| S.C. Sintofarm S.A. |
| --- |
| Str. Ziduri Între Vii Nr. 22 |
| Sector 2, Bucureşti |
| România |

S.C. Sintofarm S.A.

Str. Ziduri Între Vii Nr. 22

Sector 2, Bucureşti

România

Piroxicam 20 mg

20 mg

Tablet

Oral use

Romania

| S.C. Terapia S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| Jud. Cluj |
| România |

S.C. Terapia S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

Jud. Cluj

România

Piroxicam

20 mg

Tablet

Oral use

Romania

| S.C. Fabiol S.A. |
| --- |
| B-ul Timişoara Nr. 50 |
| Sector 6, Bucureşti |
| România |

S.C. Fabiol S.A.

B-ul Timişoara Nr. 50

Sector 6, Bucureşti

România

Piroxicam

20 mg

Tablet

Oral use

Romania

| S.C. Ac Helcor S.r.l. |
| --- |
| Str. Victor Babeş Nr. 50 |
| Baia Mare, Jud. Maramureş |
| România |

S.C. Ac Helcor S.r.l.

Str. Victor Babeş Nr. 50

Baia Mare, Jud. Maramureş

România

Piroxicam 20 mg

20 mg

Tablet

Oral use

Romania

| S.C. Arena Group S.A. |
| --- |
| Str. Ştefan Mihăileanu Nr. 31 |
| Etaj 1, Ap. 1 |
| Sector 2, Bucureşti |
| România |

S.C. Arena Group S.A.

Str. Ştefan Mihăileanu Nr. 31

Etaj 1, Ap. 1

Sector 2, Bucureşti

România

Piroxicam 20 mg

20 mg

Tablet

Oral use

Romania

| S.C. Antibiotice S.A. |
| --- |
| Str. Valea Lupului Nr. 1 |
| Iaşi |
| România |

S.C. Antibiotice S.A.

Str. Valea Lupului Nr. 1

Iaşi

România

Piroxicam 40mg

40 mg

Suppository

Rectal use

Romania

| S.C. Labormed-Pharma S.A. |
| --- |
| Splaiul Independenţei Nr. 319e |
| Sector 6, Bucureşti |
| România |

S.C. Labormed-Pharma S.A.

Splaiul Independenţei Nr. 319e

Sector 6, Bucureşti

România

Piroxicam LPH 20 mg

20 mg

Tablet

Oral use

Romania

| S.C. Mark Pharmaceutics S.r.l. |
| --- |
| Str. Moara De Foc Nr. 35 |
| Iaşi, Jud. Iaşi |
| România |

S.C. Mark Pharmaceutics S.r.l.

Str. Moara De Foc Nr. 35

Iaşi, Jud. Iaşi

România

Piroxicam Mk Crema

3 %

Cream

Cutaneous use

Romania

| S.C. Mark Pharmaceutics S.r.l. |
| --- |
| Str. Moara De Foc Nr. 35 |
| Iaşi, Jud. Iaşi |
| România |

S.C. Mark Pharmaceutics S.r.l.

Str. Moara De Foc Nr. 35

Iaşi, Jud. Iaşi

România

Piroxicam Mk Gel

1 %

Gel

Cutaneous use

Romania

| S.C. Slavia Pharm S.r.l. |
| --- |
| Str. Stirbei Vodă Nr. 53-55 |
| Sector 1, Bucureşti |
| România |

S.C. Slavia Pharm S.r.l.

Str. Stirbei Vodă Nr. 53-55

Sector 1, Bucureşti

România

Piroxsal

20 mg

Tablet

Oral use

Romania

| S.C. Slavia Pharm S.r.l. |
| --- |
| Str. Stirbei Vodă Nr. 53-55 |
| Sector 1, Bucureşti |
| România |

S.C. Slavia Pharm S.r.l.

Str. Stirbei Vodă Nr. 53-55

Sector 1, Bucureşti

România

Piroxsal Gel 0,5 g %

0,5 g %

Gel

Cutaneous use

Romania

| Ozone Laboratories Ltd |
| --- |
| 38 Princes Court |
| 88 Brompton Road |
| Knightsbridge SW3 1ES London |
| United Kingdom |

Ozone Laboratories Ltd

38 Princes Court

88 Brompton Road

Knightsbridge SW3 1ES London

United Kingdom

Piroxicam 1 %

1 %

Gel

Cutaneous use

Romania

| Ozone Laboratories Ltd |
| --- |
| 38 Princes Court |
| 88 Brompton Road |
| Knightsbridge SW3 1ES London |
| United Kingdom |

Ozone Laboratories Ltd

38 Princes Court

88 Brompton Road

Knightsbridge SW3 1ES London

United Kingdom

Piroxicam 20 mg

20 mg

Tablet

Oral use

Romania

| Ozone Laboratories Ltd |
| --- |
| 38 Princes Court |
| 88 Brompton Road |
| Knightsbridge SW3 1ES London |
| United Kingdom |

Ozone Laboratories Ltd

38 Princes Court

88 Brompton Road

Knightsbridge SW3 1ES London

United Kingdom

Piroxicam 3 %

3 %

Cream

Cutaneous use

Sweden

| Nycomed Ab |
| --- |
| Box 27264 |
| S-102 53 Stockholm |

Nycomed Ab

Box 27264

S-102 53 Stockholm

Brexidol

20 mg

Tablet

Oral use

Sweden

| Nycomed Ab |
| --- |
| Box 27264 |
| S-102 53 Stockholm |

Nycomed Ab

Box 27264

S-102 53 Stockholm

Brexidol

20 mg

Powder for oral solution

Oral use

Sweden

| Merck Nm Ab |
| --- |
| Box 23033 |
| S-104 35 Stockholm |

Merck Nm Ab

Box 23033

S-104 35 Stockholm

Piroxicam Merck Nm

10 mg

Tablet

Oral use

Sweden

| Merck Nm Ab |
| --- |
| Box 23033 |
| S-104 35 Stockholm |

Merck Nm Ab

Box 23033

S-104 35 Stockholm

Piroxicam Merck Nm

20 mg

Tablet

Oral use

Slovakia

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin 20 mg

20 mg

Granules

Oral use

Slovakia

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26 A |
| I-43100 Parma |

Chiesi Farmaceutici S.p.A.

Via Palermo 26 A

I-43100 Parma

Flamexin 20 mg

20 mg

Tablet

Oral use

Slovakia

| Egis Gyógyszergyár Nyrt. |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Gyógyszergyár Nyrt.

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

1x50 g/0,5 g

Cream

Topical use

Slovakia

| Egis Gyógyszergyár Nyrt. |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Gyógyszergyár Nyrt.

Keresztúri út 30-38.

H-1106 Budapest

Hotemin

10 mg

Capsule

Oral use

Slovakia

| Egis Gyógyszergyár Nyrt. |
| --- |
| Keresztúri út 30-38. |
| H-1106 Budapest |

Egis Gyógyszergyár Nyrt.

Keresztúri út 30-38.

H-1106 Budapest

Hotemin 20 mg

20 mg

Solution for injection

Parenteral use

Slovakia

| Pro.Med.Cs Praha a.s. |
| --- |
| Telčská 1 |
| CZ-140 00 Praha 4 |

Pro.Med.Cs Praha a.s.

Telčská 1

CZ-140 00 Praha 4

Pro-Roxikam 10 mg

10 mg

Tablet

Oral use

Slovakia

| Pro.Med.Cs Praha a.s. |
| --- |
| Telčská 1 |
| CZ-140 00 Praha 4 |

Pro.Med.Cs Praha a.s.

Telčská 1

CZ-140 00 Praha 4

Pro-Roxikam 20 mg

20 mg

Tablet

Oral use

Slovenia

| Krka tovarna zdravil, d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo Mesto |

Krka tovarna zdravil, d.d.

Šmarješka cesta 6

SLO-8501 Novo Mesto

Erazon

20 mg

Capsule, hard

Oral use

Slovenia

| Krka tovarna zdravil, d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo Mesto |

Krka tovarna zdravil, d.d.

Šmarješka cesta 6

SLO-8501 Novo Mesto

Erazon

10 mg/1 g

Cream

Cutaneous use

Slovenia

| Krka tovarna zdravil, d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo Mesto |

Krka tovarna zdravil, d.d.

Šmarješka cesta 6

SLO-8501 Novo Mesto

Erazon

10 mg/1 g

Gel

Cutaneous use

Slovenia

| Krka tovarna zdravil, d.d. |
| --- |
| Šmarješka cesta 6 |
| SLO-8501 Novo Mesto |

Krka tovarna zdravil, d.d.

Šmarješka cesta 6

SLO-8501 Novo Mesto

Erazon

20 mg

Suppository

Rectal use

United Kingdom

| Pfizer Limited |
| --- |
| Walton Oaks |
| Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks

Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene Capsules 10 mg

10 mg

Capsule

Oral use

United Kingdom

| Pfizer Limited |
| --- |
| Walton Oaks |
| Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks

Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene 20 (20 mg Capsules)

20 mg

Capsule

Oral use

United Kingdom

| Pfizer Limited |
| --- |
| Walton Oaks |
| Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks

Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene Dispersable Tablets 10 mg

10 mg

Tablet for oral solution

Oral use

United Kingdom

| Pfizer Limited |
| --- |
| Walton Oaks |
| Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks

Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene Dispersible Tablets-20 mg

20 mg

Tablet for oral solution

Oral use

United Kingdom

| Pfizer Limited |
| --- |
| Walton Oaks |
| Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks

Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene Gel 0,5 % W/W

0,5 % w/w

Gel

Cutaneous use

United Kingdom

| Pfizer Limited |
| --- |
| Walton Oaks |
| Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks

Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene Intramuscular Injection 20 mg/ml

20 mg/ml

Solution for injection

Intramuscular use

United Kingdom

| Pfizer Limited |
| --- |
| Walton Oaks |
| Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Limited

Walton Oaks

Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene Melt 20 mg Tablets

20 mg

Tablet for oral solution

Oral use

United Kingdom

| Actavis Uk Limited |
| --- |
| Whiddon Vally |
| Barnstaple |
| Devon Ex32 8NS |
| United Kingdom |

Actavis Uk Limited

Whiddon Vally

Barnstaple

Devon Ex32 8NS

United Kingdom

Piroxicam Capsules 10 mg

10 mg

Capsule

Oral use

United Kingdom

| Actavis Uk Limited |
| --- |
| Whiddon Vally |
| Barnstaple |
| Devon Ex32 8ns |
| United Kingdom |

Actavis Uk Limited

Whiddon Vally

Barnstaple

Devon Ex32 8ns

United Kingdom

Piroxicam Capsules 20 mg

20 mg

Capsule

Oral use

United Kingdom

| Clonmel Healthcare Limited |
| --- |
| Waterford Road |
| Clonmel Co. Tipperary |
| Ireland |

Clonmel Healthcare Limited

Waterford Road

Clonmel Co. Tipperary

Ireland

Kentene,Piroflam Piroflex

10 mg

Capsule, hard

Oral use

United Kingdom

| Clonmel Healthcare Limited |
| --- |
| Waterford Road |
| Clonmel Co. Tipperary |
| Ireland |

Clonmel Healthcare Limited

Waterford Road

Clonmel Co. Tipperary

Ireland

Kentene,Piroflam Piroflex

20 mg

Capsule, hard

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Unit 37 |
| Woolmer Way |
| Bordon |
| Hampshire Gu35 9QE |
| United Kingdom |

Sandoz Limited

Unit 37

Woolmer Way

Bordon

Hampshire Gu35 9QE

United Kingdom

Piroxicam 10 mg Capsules

10 mg

Capsule

Oral use

United Kingdom

| Sandoz Limited |
| --- |
| Unit 37 |
| Woolmer Way |
| Bordon |
| Hampshire Gu35 9QE |
| United Kingdom |

Sandoz Limited

Unit 37

Woolmer Way

Bordon

Hampshire Gu35 9QE

United Kingdom

Piroxicam 20 mg Capsules

20 mg

Capsule

Oral use

United Kingdom

| Pharmvit Limited |
| --- |
| Unit 13 |
| Metropolitan Centre |
| Derby Road |
| Greenford |
| Middlesex UB6 8UJ |
| United Kingdom |

Pharmvit Limited

Unit 13

Metropolitan Centre

Derby Road

Greenford

Middlesex UB6 8UJ

United Kingdom

Piroxicam 10 mg Capsules Bp

10 mg

Capsule, hard

Oral use

United Kingdom

| Pharmvit Limited |
| --- |
| Unit 13 |
| Metropolitan Centre |
| Derby Road |
| Greenford |
| Middlesex UB6 8UJ |
| United Kingdom |

Pharmvit Limited

Unit 13

Metropolitan Centre

Derby Road

Greenford

Middlesex UB6 8UJ

United Kingdom

Piroxicam 20 mg Capsules Bp

20 mg

Capsule, hard

Oral use

United Kingdom

| Generics Uk Limited |
| --- |
| Albany Gate |
| Darkes Lane |
| Potters Bar |
| Herts EN6 1AG |
| United Kingdom |

Generics Uk Limited

Albany Gate

Darkes Lane

Potters Bar

Herts EN6 1AG

United Kingdom

Piroxicam Capsules 10 mg

10 mg

Capsule

Oral use

United Kingdom

| Generics Uk Limited |
| --- |
| Albany Gate |
| Darkes Lane |
| Potters Bar |
| Herts EN6 1AG |
| United Kingdom |

Generics Uk Limited

Albany Gate

Darkes Lane

Potters Bar

Herts EN6 1AG

United Kingdom

Piroxicam Capsules 20 mg

20 mg

Capsule

Oral use

United Kingdom

| Generics Uk Limited |
| --- |
| Albany Gate |
| Darkes Lane |
| Potters Bar |
| Herts EN6 1AG |
| United Kingdom |

Generics Uk Limited

Albany Gate

Darkes Lane

Potters Bar

Herts EN6 1AG

United Kingdom

Piroxicam Dispersible Tablets 10 mg

10 mg

Tablet for oral solution

Oral use

United Kingdom

| Generics Uk Limited |
| --- |
| Albany Gate |
| Darkes Lane |
| Potters Bar |
| Herts EN6 1AG |
| United Kingdom |

Generics Uk Limited

Albany Gate

Darkes Lane

Potters Bar

Herts EN6 1AG

United Kingdom

Piroxicam Dispersible Tablets 20 mg

20 mg

Tablet for oral solution

Oral use

United Kingdom

| Waymade Plc |
| --- |
| Sovereign House |
| Miles Gray Road |
| Basildon |
| Essex SS14 3FR |
| United Kingdom |

Waymade Plc

Sovereign House

Miles Gray Road

Basildon

Essex SS14 3FR

United Kingdom

Piroxicam 0,5 % Gel

0,5 % w/w

Gel

Cutaneous use

United Kingdom

| Neolab Limited |
| --- |
| 57 High Street |
| Odiham |
| Hampshire RG29 1LF |
| United Kingdom |

Neolab Limited

57 High Street

Odiham

Hampshire RG29 1LF

United Kingdom

Piroxicam 0,5 % Gel

0,5 % w/w

Gel

Cutaneous use

United Kingdom

| Neolab Limited |
| --- |
| 57 High Street |
| Odiham |
| Hampshire RG29 1LF |
| United Kingdom |

Neolab Limited

57 High Street

Odiham

Hampshire RG29 1LF

United Kingdom

Piroxicam 0,5 % Gel

0,5 % w/w

Gel

Cutaneous use

United Kingdom

| Dr Reddy's Laboratories (Uk) Limited |
| --- |
| 6 Riverview Road |
| Beverley |
| E Yorks HU17 0LD |
| United Kingdom |

Dr Reddy's Laboratories (Uk) Limited

6 Riverview Road

Beverley

E Yorks HU17 0LD

United Kingdom

Piroxicam 0,5 % Gel

0,5 % w/w

Gel

Cutaneous use

United Kingdom

| Trinity-Chiesi Pharmaceuticals Limited |
| --- |
| Cheadlw Royal Business Park |
| Highfield |
| Cheadle SK8 3GY |
| United Kingdom |

Trinity-Chiesi Pharmaceuticals Limited

Cheadlw Royal Business Park

Highfield

Cheadle SK8 3GY

United Kingdom

Brexidol 20 mg Tablets

20 mg

Tablet

Oral use

United Kingdom

| Trinity-Chiesi Pharmaceuticals Limited |
| --- |
| Cheadlw Royal Business Park |
| Highfield |
| Cheadle SK8 3GY |
| United Kingdom |

Trinity-Chiesi Pharmaceuticals Limited

Cheadlw Royal Business Park

Highfield

Cheadle SK8 3GY

United Kingdom

Brexidol 20 mg Effervescent Tablets

20 mg

Effervescent tablet

Oral use

United Kingdom

| Pliva Pharma Limited |
| --- |
| Vision House Bedford Road |
| Petersfield |
| Hampsire GU32 3QB |
| United Kingdom |

Pliva Pharma Limited

Vision House Bedford Road

Petersfield

Hampsire GU32 3QB

United Kingdom

Piroxicam 0,5 % Gel

0,5 % w/w

Gel

Cutaneous use

United Kingdom

| Tillomed Laboratories Limited |
| --- |
| 3 Howard Road Eaton Socon |
| St. Neots |
| Cambs PE19 3ET |
| United Kingdom |

Tillomed Laboratories Limited

3 Howard Road Eaton Socon

St. Neots

Cambs PE19 3ET

United Kingdom

Pirozip 10

10 mg

Capsule

Oral use

United Kingdom

| Tillomed Laboratories Limited |
| --- |
| 3 Howard Road Eaton Socon |
| St. Neots |
| Cambs PE19 3ET |
| United Kingdom |

Tillomed Laboratories Limited

3 Howard Road Eaton Socon

St. Neots

Cambs PE19 3ET

United Kingdom

Pirozip 20

20 mg

Capsule

Oral use

United Kingdom

| Manx Healthcare |
| --- |
| Taylor Group House |
| Wedgnock Lane |
| Warwick CV34 5YA |
| United Kingdom |

Manx Healthcare

Taylor Group House

Wedgnock Lane

Warwick CV34 5YA

United Kingdom

Piroxicam Gel 0,5 %W/W

0,5 % w/w

Gel

Cutaneous use

United Kingdom

| Teva Pharma B.V. |
| --- |
| Industrieweg 23 |
| PO Box 217 |
| 3640 AE Mijdrecht |
| Nederland |

Teva Pharma B.V.

Industrieweg 23

PO Box 217

3640 AE Mijdrecht

Nederland

Flamatrol 10 mg Capsules

10 mg

Capsule

Oral use

United Kingdom

| Teva Pharma B.V. |
| --- |
| Industrieweg 23 |
| PO Box 217 |
| 3640 AE Mijdrecht |
| Nederland |

Teva Pharma B.V.

Industrieweg 23

PO Box 217

3640 AE Mijdrecht

Nederland

Flamatrol 20 mg Capsules

20 mg

Capsule

Oral use

United Kingdom

| Pfizer Consumer Healthcare |
| --- |
| Walton Oaks |
| Dorking Road |
| Walton-on-the-Hill |
| Surrey KT20 7NS |
| United Kingdom |

Pfizer Consumer Healthcare

Walton Oaks

Dorking Road

Walton-on-the-Hill

Surrey KT20 7NS

United Kingdom

Feldene P Gel

0,5 % w/w

Gel

Cutaneous use

United Kingdom

| Crescent Pharma Limited |
| --- |
| Units 3&4 |
| Quidhampton Business Units |
| Polhampton Lane |
| Overton |
| Hampshire RG25 3ED |
| United Kingdom |

Crescent Pharma Limited

Units 3&4

Quidhampton Business Units

Polhampton Lane

Overton

Hampshire RG25 3ED

United Kingdom

Piroxicam Capsules Bp 10 mg

10 mg

Capsule

Oral use

United Kingdom

| Crescent Pharma Limited |
| --- |
| Units 3&4 |
| Quidhampton Business Units |
| Polhampton Lane |
| Overton |
| Hampshire RG25 3ED |
| United Kingdom |

Crescent Pharma Limited

Units 3&4

Quidhampton Business Units

Polhampton Lane

Overton

Hampshire RG25 3ED

United Kingdom

Piroxicam Capsules Bp 20 mg

20 mg

Capsule

Oral use

United Kingdom

| Strides Arcolab International Limited |
| --- |
| 201 Jersey Road |
| Isleworth |
| Middx TW7 4QJ |
| United Kingdom |

Strides Arcolab International Limited

201 Jersey Road

Isleworth

Middx TW7 4QJ

United Kingdom

Piroxicam 10 mg Capsules

10 mg

Capsule

Oral use

United Kingdom

| Strides Arcolab International Limited |
| --- |
| 201 Jersey Road |
| Isleworth |
| Middx TW7 4QJ |
| United Kingdom |

Strides Arcolab International Limited

201 Jersey Road

Isleworth

Middx TW7 4QJ

United Kingdom

Piroxicam 20 mg Capsules

20 mg

Capsule

Oral use

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | | Teva Pharma B.V. |
| Industrieweg 23 |
| P.O. Box 217 |
| 3640 AE Mijdrecht |
| Nederland |

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Austria

Teva Pharma B.V.

Industrieweg 23

P.O. Box 217

3640 AE Mijdrecht

Nederland

Lansoprazol TEVA 15 mg Kapseln

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol TEVA 30 mg Kapseln

30 mg

Gastro-resistant capsule, hard

Oral use

Belgium

| IPS N.V. |
| --- |
| Jozef Nellenslei 10 |
| B-2100 Deurne |

IPS N.V.

Jozef Nellenslei 10

B-2100 Deurne

Lansoprazol IPS 15 mg maagsapresistente capsules

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol IPS 30 mg maagsapresistente capsules

30 mg

Gastro-resistant capsule, hard

Oral use

Czech Republic

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Drážní 7 |
| CZ-627 00 Brno |

Teva Pharmaceuticals CR, s.r.o.

Drážní 7

CZ-627 00 Brno

Lansoprazol TEVA 15 mg

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol TEVA 30 mg

30 mg

Gastro-resistant capsule, hard

Oral use

Germany

| TEVA Generics GmbH |
| --- |
| Kandelstraße 10 |
| D-79199 Kirchzarten |

TEVA Generics GmbH

Kandelstraße 10

D-79199 Kirchzarten

Lansoprazol TEVA® 15 mg magensaftresistente Hartkapseln

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol TEVA® 30 mg magensaftresistente Hartkapseln

30 mg

Gastro-resistant capsule, hard

Oral use

Denmark

| Teva Pharma B.V. |
| --- |
| Industrieweg 23 |
| P.O. Box 217 |
| 3640 AE Mijdrecht |
| Nederland |

Teva Pharma B.V.

Industrieweg 23

P.O. Box 217

3640 AE Mijdrecht

Nederland

Lansoprazol TEVA 15 mg enterokapsler

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol TEVA 30 mg enterokapsler

30 mg

Gastro-resistant capsule, hard

Oral use

Spain

| TEVA Genéricos Española S.L. |
| --- |
| C/Guzmán El Bueno, 133 |
| Ed. Britannia 4o Izda. |
| E-28003 Madrid |

TEVA Genéricos Española S.L.

C/Guzmán El Bueno, 133

Ed. Britannia 4o Izda.

E-28003 Madrid

Lansoprazol TEVAGEN 15 mg cápsulas duras gastrorresistentes EFG

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol TEVAGEN 30 mg cápsulas duras gastrorresistentes EFG

30 mg

Gastro-resistant capsule, hard

Oral use

Finland

| Teva Pharma B.V. |
| --- |
| Industrieweg 23 |
| P.O. Box 217 |
| 3640 AE Mijdrecht |
| Nederland |

Teva Pharma B.V.

Industrieweg 23

P.O. Box 217

3640 AE Mijdrecht

Nederland

Lansoprazol Teva, 15 mg enterokapseli, kova

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol Teva, 30 mg enterokapseli, kova

30 mg

Gastro-resistant capsule, hard

Oral use

France

| TEVA Classics S.A. |
| --- |
| 1, cours du Triangle |
| Immeuble Palatin 1 |
| F-92936 Paris La Défense cedex 12 |

TEVA Classics S.A.

1, cours du Triangle

Immeuble Palatin 1

F-92936 Paris La Défense cedex 12

Lansoprazole TEVA 15 mg microgranules gastro résistantes en gélule

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazole TEVA 30 mg microgranules gastro résistantes en gélule

30 mg

Gastro-resistant capsule, hard

Oral use

Hungary

| TEVA Magyarország Rt. |
| --- |
| Rákóczi út 70-72. |
| H-1074 Budapest |

TEVA Magyarország Rt.

Rákóczi út 70-72.

H-1074 Budapest

Lansoflux Teva 15 mg kapszula

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoflux Teva 30 mg kapszula

30 mg

Gastro-resistant capsule, hard

Oral use

Ireland

| Teva Pharma B.V. |
| --- |
| Industrieweg 23 |
| P.O. Box 217 |
| 3640 AE Mijdrecht |
| Nederland |

Teva Pharma B.V.

Industrieweg 23

P.O. Box 217

3640 AE Mijdrecht

Nederland

Lansoprazole TEVA 15 mg Gastro-resistant Capsules

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazole TEVA 30 mg Gastro-resistant Capsules

30 mg

Gastro-resistant capsule, hard

Oral use

The Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| Postbus 552 |
| 2003 RN Haarlem |
| Nederland |

Pharmachemie B.V.

Swensweg 5

Postbus 552

2003 RN Haarlem

Nederland

Lansoprazol 15 mg PCH, maagsapresistente capsule

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol 30 mg PCH, maagsapresistente capsule

30 mg

Gastro-resistant capsule, hard

Oral use

Norway

| Teva Pharma B.V. |
| --- |
| Industrieweg 23 |
| P.O. Box 217 |
| 3640 AE Mijdrecht |
| Nederland |

Teva Pharma B.V.

Industrieweg 23

P.O. Box 217

3640 AE Mijdrecht

Nederland

Lansoprazol TEVA 15 mg enterokapseler, harde

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol TEVA 30 mg enterokapseler, harde

30 mg

Gastro-resistant capsule, hard

Oral use

Poland

| Teva Pharmaceuticals Polska Sp. z o.o. |
| --- |
| E. Plater 53 |
| PL-00-113 Warsaw |

Teva Pharmaceuticals Polska Sp. z o.o.

E. Plater 53

PL-00-113 Warsaw

LansoTEVA 15 mg kapsulka dojelitowa twarda

15 mg

Gastro-resistant capsule, hard

Oral use

LansoTEVA 30 mg kapsulka dojelitowa twarda

30 mg

Gastro-resistant capsule, hard

Oral use

Portugal

| TEVA Pharma-Produtos Farmacêuticos Lda |
| --- |
| Lagoas Park |
| Edifício 1 |
| Piso 3 |
| P-2740-264 Porto Salvo |

TEVA Pharma-Produtos Farmacêuticos Lda

Lagoas Park

Edifício 1

Piso 3

P-2740-264 Porto Salvo

Lansoprazol TEVA 15 mg cápsula gastro-resistente

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol TEVA 30 mg cápsula gastro-resistente

30 mg

Gastro-resistant capsule, hard

Oral use

Sweden

| TEVA Sweden AB |
| --- |
| PO Box 1070 |
| S-25110 Helsingborg |

TEVA Sweden AB

PO Box 1070

S-25110 Helsingborg

Lansoprazol TEVA 15 mg enterokapslar, hårda

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol TEVA 30 mg enterokapslar, hårda

30 mg

Gastro-resistant capsule, hard

Oral use

Slovak Republic

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Drážní 7 |
| CZ-627 00 Brno |

Teva Pharmaceuticals CR, s.r.o.

Drážní 7

CZ-627 00 Brno

Lansoprazol TEVA 15 mg

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazol TEVA 30 mg

30 mg

Gastro-resistant capsule, hard

Oral use

United Kingdom

| TEVA UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| East Sussex BN22 9AG |
| United Kingdom |

TEVA UK Limited

Brampton Road

Hampden Park

Eastbourne

East Sussex BN22 9AG

United Kingdom

| TEVA UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| East Sussex BN22 9AG |
| United Kingdom |

TEVA UK Limited

Brampton Road

Hampden Park

Eastbourne

East Sussex BN22 9AG

United Kingdom

Lansoprazole 15 mg Gastro-resistant Capsules

15 mg

Gastro-resistant capsule, hard

Oral use

Lansoprazole 30 mg Gastro-resistant Capsules

30 mg

Gastro-resistant capsule, hard

Oral use

---

NOTICES FROM MEMBER STATES

| 26.10.2007 | EN | Official Journal of the European Union | C 251/103 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/103

---

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 70/2001 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises

(Text with EEA relevance)

(2007/C 251/11)

| Aid No | XS 232/07 |
| --- | --- |
| Member State | Italy |
| Region | Umbria |
| Title of aid scheme | L. 598/94 art.11 — Interventi per ricerca industriale e sviluppo precompetitivo |
| Legal basis | Deliberazione della Giunta regionale del 9.7.2007 n. 1162 |
| Annual expenditure planned | EUR 20 000 000 |
| Maximum aid intensity | SMEs: a capital grant of 35 % of eligible costs of pre-competitive (experimental) development.
  SMEs: a capital grant of 60 % of eligible costs of industrial research projects.
  For SMEs located in areas in the Umbria Region assisted under Article 87(3)(c) of the EC Treaty, the grant is raised by 5 % |
| Date of implementation | 18.7.2007 |
| Duration of scheme | 31.12.2008 |
| Objective of the aid | Support to pre-competitive (experimental) development programmes comprising industrial research not yet widely conducted, and carried out by SMEs or consortia of SMEs directly active in the production of goods and/or the provision of services.
  The eligible cost of the proposed projects must be between EUR 100 000 and EUR 1 000 000, raised to EUR 1 250 000 for projects involving one of the clusters in the Umbria Technology Park (Distretto Tecnologico dell'Umbria — DTU) |
| Economic sectors | LIST OF ELIGIBLE ECONOMIC ACTIVITIES under the ATECO 2002 Classification of Economic Activities
  C —   Mining and quarrying
  The whole sector is eligible, with the exception of the following codes:






  13.10 | ‘Mining of iron ores’ — Whole class excluded except for pyrites |
| 13.20 | ‘Mining of non-ferrous metal ores’ — Only manganese excluded |

Aid No

XS 232/07

Member State

Italy

Region

Umbria

Title of aid scheme

L. 598/94 art.11 — Interventi per ricerca industriale e sviluppo precompetitivo

Legal basis

Deliberazione della Giunta regionale del 9.7.2007 n. 1162

Annual expenditure planned

EUR 20 000 000

Maximum aid intensity

SMEs: a capital grant of 35 % of eligible costs of pre-competitive (experimental) development.

SMEs: a capital grant of 60 % of eligible costs of industrial research projects.

For SMEs located in areas in the Umbria Region assisted under Article 87(3)(c) of the EC Treaty, the grant is raised by 5 %

Date of implementation

18.7.2007

Duration of scheme

31.12.2008

Objective of the aid

Support to pre-competitive (experimental) development programmes comprising industrial research not yet widely conducted, and carried out by SMEs or consortia of SMEs directly active in the production of goods and/or the provision of services.

The eligible cost of the proposed projects must be between EUR 100 000 and EUR 1 000 000, raised to EUR 1 250 000 for projects involving one of the clusters in the Umbria Technology Park (Distretto Tecnologico dell'Umbria — DTU)

Economic sectors

LIST OF ELIGIBLE ECONOMIC ACTIVITIES under the ATECO 2002 Classification of Economic Activities

C —   Mining and quarrying

The whole sector is eligible, with the exception of the following codes:

13.10

‘Mining of iron ores’ — Whole class excluded except for pyrites

13.20

‘Mining of non-ferrous metal ores’ — Only manganese excluded

D —   Manufacturing

The whole sector is eligible, with the exception of the following codes:

| 23.1 | ‘Manufacture of coke oven products’ — Whole group excluded |
| --- | --- |
| 24.70 | ‘Manufacture of man-made fibres’ — Whole category excluded |
| 27.10 | ‘Manufacture of iron, steel and ferro-alloys (ECSC)’ — The entire iron and steel industry as defined in the ECSC Treaty is excluded |
| 27.22.1 | ‘Manufacture of seamless tubes’ — The whole category is excluded |
| 27.22.2 | ‘Manufacture of closed, seamed, welded and similar tubes’ — Only the manufacture of tubes with a diameter exceeding 406,4 mm is excluded |
| 35.11.1 | ‘Shipyards producing metal ships’ |
| 35.11.3 | ‘Ship-repair yards’ |

23.1

‘Manufacture of coke oven products’ — Whole group excluded

24.70

‘Manufacture of man-made fibres’ — Whole category excluded

27.10

‘Manufacture of iron, steel and ferro-alloys (ECSC)’ — The entire iron and steel industry as defined in the ECSC Treaty is excluded

27.22.1

‘Manufacture of seamless tubes’ — The whole category is excluded

27.22.2

‘Manufacture of closed, seamed, welded and similar tubes’ — Only the manufacture of tubes with a diameter exceeding 406,4 mm is excluded

35.11.1

‘Shipyards producing metal ships’

35.11.3

‘Ship-repair yards’

E —   Production and distribution of electricity

The entire section is eligible.

F —   Construction

The entire section is eligible.

I —   Transport, storage and communication

Only the following codes are eligible: 63.11; 63.12; 63.21; 63.22; 63.23; 63.40; 64.20.

K —   Real estate, renting, information technology, research and other professional and business activities

Only the following codes are eligible: 72.10; 72.2; 72.30; 72.40; 72.50; 72.60; 73.10; 73.20.

O —   Other community, social and personal service activities

Only the following codes are eligible: 90.02.0; 90.01.0; 92.20; 93.01.1.

FURTHER EXCLUSIONS

The aid is not available for the manufacture of products imitating or replacing milk and other dairy commodities as defined by Community legislation

Name and address of the granting authority

| Regione Umbria — Giunta regionale |
| --- |
| Direzione regionale Sviluppo economico e attività produttive, istruzione, formazione e lavoro |
| Servizio Politiche di sostegno alle imprese |
| Via Mario Angeloni, 61 |
| I-06124 Perugia |

Regione Umbria — Giunta regionale

Direzione regionale Sviluppo economico e attività produttive, istruzione, formazione e lavoro

Servizio Politiche di sostegno alle imprese

Via Mario Angeloni, 61

I-06124 Perugia

| Aid No | XS 244/07 |
| --- | --- |
| Member State | The Netherlands |
| Region | Not applicable |
| Title of aid scheme or name of company receiving individual aid | Stichting Kenniscentrum Windturbine Materialen en Constructies (WMC) |
| Legal basis | Kaderwet EZ-subsidies |
| Annual expenditure planned under the scheme or overall amount of individual aid granted to the company | Aid scheme | Annual overall amount | — |
| Loans guaranteed | — |
| Individual aid | Overall aid amount | EUR 835 625 |
| Loans guaranteed | — |
| Maximum aid intensity | In conformity with Articles 4(2)-(6) and 5 of the Regulation | Yes
  Individual aid for research and development that does not exceed the maximum aid percentages |
| Date of implementation | 11.6.2007 |
| Duration of scheme or duration of the individual aid | From 1.1.2007 up to and including 31.12.2007 |
| Objective | Aid to SMEs | Yes
  Individual aid for research and development |
| Economic sectors | All sectors eligible for aid to SMEs | Individual aid |
| Name and address of the granting authority | Ministerie van Economische Zaken |
| Bezuidenhoutseweg 30 |
| 2500 EC Den Haag |
| Nederland |

Aid No

XS 244/07

Member State

The Netherlands

Region

Not applicable

Title of aid scheme or name of company receiving individual aid

Stichting Kenniscentrum Windturbine Materialen en Constructies (WMC)

Legal basis

Kaderwet EZ-subsidies

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company

Aid scheme

Annual overall amount

—

Loans guaranteed

—

Individual aid

Overall aid amount

EUR 835 625

Loans guaranteed

—

Maximum aid intensity

In conformity with Articles 4(2)-(6) and 5 of the Regulation

Yes

Individual aid for research and development that does not exceed the maximum aid percentages

Date of implementation

11.6.2007

Duration of scheme or duration of the individual aid

From 1.1.2007 up to and including 31.12.2007

Objective

Aid to SMEs

Yes

Individual aid for research and development

Economic sectors

All sectors eligible for aid to SMEs

Individual aid

Name and address of the granting authority

Ministerie van Economische Zaken

Bezuidenhoutseweg 30

2500 EC Den Haag

Nederland

Large individual aid grants

In conformity with Article 6 of the Regulation

Yes

| Aid No | XS 245/07 |
| --- | --- |
| Member State | Federal Republic of Germany |
| Region | — |
| Title of aid scheme or name of company receiving individual aid | Richtlinien des Bundesministeriums für Ernährung, Landwirtschaft und Verbraucherschutz (BMELV) über die Verwendung des Zweckvermögens des Bundes bei der Landwirtschaftlichen Rentenbank (LR), Ziffer 2.1 vorwettbewerbliche Entwicklungsvorhaben und Ziffer 2.2 Markt- und Praxiseinführung |
| Legal basis | § 2 Abs. 1 des Gesetzes über das Zweckvermögen des Bundes bei der Landwirtschaftlichen Rentenbank vom 12. August 2005 (BGBl. I S. 1363), zuletzt geändert durch Art. 175 der Neunten Zuständigkeitsanpassungsverordnung vom 31. Oktober 2006 (BGBl. I S. 24077) |
| Annual expenditure planned under the scheme or overall amount of individual aid granted to the company | Aid scheme | Pre-competitive development | EUR 1,5 million |
| Annual overall amount (grants) | |
| Introduction to market and practical use | EUR 2,5 million |
| Annual overall amount (soft loans) | |
| Individual aid | Overall aid amount | — |
| Loans guaranteed | — |
| Maximum aid intensity | In conformity with Article 4(2)-(7) and Article 5 of the Regulation | Yes |
| Date of implementation | 24.8.2007 |
| End of implementation or individual aid — last instalment | 30.6.2008 |
| Objective of aid | Aid to small and medium-sized enterprises | Yes |
| Economic sector(s) concerned | All sectors eligible for aid to SMEs | Yes |
| Name and address of the granting authority | Landwirtschaftliche Rentenbank |
| Hochstr. 2 |
| D-60313 Frankfurt am Main |

Aid No

XS 245/07

Member State

Federal Republic of Germany

Region

—

Title of aid scheme or name of company receiving individual aid

Richtlinien des Bundesministeriums für Ernährung, Landwirtschaft und Verbraucherschutz (BMELV) über die Verwendung des Zweckvermögens des Bundes bei der Landwirtschaftlichen Rentenbank (LR), Ziffer 2.1 vorwettbewerbliche Entwicklungsvorhaben und Ziffer 2.2 Markt- und Praxiseinführung

Legal basis

§ 2 Abs. 1 des Gesetzes über das Zweckvermögen des Bundes bei der Landwirtschaftlichen Rentenbank vom 12. August 2005 (BGBl. I S. 1363), zuletzt geändert durch Art. 175 der Neunten Zuständigkeitsanpassungsverordnung vom 31. Oktober 2006 (BGBl. I S. 24077)

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company

Aid scheme

Pre-competitive development

EUR 1,5 million

Annual overall amount (grants)

Introduction to market and practical use

EUR 2,5 million

Annual overall amount (soft loans)

Individual aid

Overall aid amount

—

Loans guaranteed

—

Maximum aid intensity

In conformity with Article 4(2)-(7) and Article 5 of the Regulation

Yes

Date of implementation

24.8.2007

End of implementation or individual aid — last instalment

30.6.2008

Objective of aid

Aid to small and medium-sized enterprises

Yes

Economic sector(s) concerned

All sectors eligible for aid to SMEs

Yes

Name and address of the granting authority

Landwirtschaftliche Rentenbank

Hochstr. 2

D-60313 Frankfurt am Main

Large individual aid grants

In conformity with Article 6 of the Regulation

Yes

| Aid number | XS 252/07 |
| --- | --- |
| Member State | Austria |
| Region | Oberösterreich |
| Title of Aid scheme or name of company receiving an individual aid | Tourismus-Impulsprogramm (TIP/Betriebe) des Landes Oberösterreich für den Zeitraum 1.9.2007-31.12.2013 |
| Legal basis | Beschluss der Oö. Landesregierung vom 16.7.2007 |
| Annual expenditure planned under the scheme or overall amount of individual aid granted to the company | Aid scheme | Annual total amount | EUR 2,5 million |
| Maximum aid intensity | In conformity with Articles 4(2)-(6) and 5 of the Regulation | Yes |
| Date of implementation | 1.9.2007 |
| Duration of scheme or individual aid award | 30.6.2008 |
| Objective of aid | To provide support for SMEs | Yes |
| Economic sectors | Limited to the following sectors | Yes |
| — | Accommodation and food service activities |

Aid number

XS 252/07

Member State

Austria

Region

Oberösterreich

Title of Aid scheme or name of company receiving an individual aid

Tourismus-Impulsprogramm (TIP/Betriebe) des Landes Oberösterreich für den Zeitraum 1.9.2007-31.12.2013

Legal basis

Beschluss der Oö. Landesregierung vom 16.7.2007

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company

Aid scheme

Annual total amount

EUR 2,5 million

Maximum aid intensity

In conformity with Articles 4(2)-(6) and 5 of the Regulation

Yes

Date of implementation

1.9.2007

Duration of scheme or individual aid award

30.6.2008

Objective of aid

To provide support for SMEs

Yes

Economic sectors

Limited to the following sectors

Yes

—

Accommodation and food service activities

Yes

| — | Transport restricted to inland passenger water transport, transport by cable ways, chair lift and drag lift and travel agencies and tour operators |
| --- | --- |

—

Transport restricted to inland passenger water transport, transport by cable ways, chair lift and drag lift and travel agencies and tour operators

Yes

Name and address of the granting authority

Land Oberösterreich

Für die Durchführung verantwortliche staatl. Stelle:

| Amt der Oö. Landesregierung, Abteilung Gewerbe/Wirtschaftspolitik |
| --- |
| Bahnhofsplatz 1 |
| A-4021 Linz |

Amt der Oö. Landesregierung, Abteilung Gewerbe/Wirtschaftspolitik

Bahnhofsplatz 1

A-4021 Linz

Large individual aid grants

In conformity with Article 6 of the Regulation

Yes

(not planned)

| Aid No | XS 265/07 |
| --- | --- |
| Member State | United Kingdom |
| Region | Wales |
| Title of aid scheme or name of company receiving individual aid | Welsh Local Government SME Development scheme |
| Legal basis | The Local Government Act 2000 (C 22), Part 1 |
| Type of measure | Aid scheme |
| Budget | Annual budget: GBP 1 million; overall budget: — |
| Maximum aid intensity | In conformity with Articles 4(2)-(6) and 5 of the Regulation |
| Date of implementation | 1.10.2007 |
| Duration | 30.6.2008 |
| Objective | Small and medium-sized enterprises |
| Economic sectors | All sectors eligible for aid to SMEs |
| Name and address of the granting authority | All Local Authorities in Wales: Blaenau Gwent County Borough Council, Bridgend County Borough Council, Caerphilly County Borough Council, City and County of Cardiff, Carmarthenshire County Council, Ceredigion County Council, Conwy County Borough Council, Denbighshire County Council, Flintshire County Council, Gwynedd Council, Isle of Anglesey County Council, Merthyr Tydfil County Borough Council, Monmouthshire County Council, Neath Port Talbot County Borough Council, Newport City Council, Pembrokeshire County Council, Powys County Council, Rhondda Cynon Taf County Borough Council, City and County of Swansea, Torfaen County Borough Council, Vale of Glamorgan Council and Wrexham County Borough Council. |
| c/o Welsh Local Government Association |
| Local Government House |
| Drake Walk |
| Cardiff CF10 4LG |
| United Kingdom |
| Tel. (44-292) 046 86 00 |
| Fax (44-292) 046 86 01 |
| E-mail: regeneration@wlga.gov.uk |

Aid No

XS 265/07

Member State

United Kingdom

Region

Wales

Title of aid scheme or name of company receiving individual aid

Welsh Local Government SME Development scheme

Legal basis

The Local Government Act 2000 (C 22), Part 1

Type of measure

Aid scheme

Budget

Annual budget: GBP 1 million; overall budget: —

Maximum aid intensity

In conformity with Articles 4(2)-(6) and 5 of the Regulation

Date of implementation

1.10.2007

Duration

30.6.2008

Objective

Small and medium-sized enterprises

Economic sectors

All sectors eligible for aid to SMEs

Name and address of the granting authority

All Local Authorities in Wales: Blaenau Gwent County Borough Council, Bridgend County Borough Council, Caerphilly County Borough Council, City and County of Cardiff, Carmarthenshire County Council, Ceredigion County Council, Conwy County Borough Council, Denbighshire County Council, Flintshire County Council, Gwynedd Council, Isle of Anglesey County Council, Merthyr Tydfil County Borough Council, Monmouthshire County Council, Neath Port Talbot County Borough Council, Newport City Council, Pembrokeshire County Council, Powys County Council, Rhondda Cynon Taf County Borough Council, City and County of Swansea, Torfaen County Borough Council, Vale of Glamorgan Council and Wrexham County Borough Council.

c/o Welsh Local Government Association

Local Government House

Drake Walk

Cardiff CF10 4LG

United Kingdom

Tel. (44-292) 046 86 00

Fax (44-292) 046 86 01

E-mail: regeneration@wlga.gov.uk

---

| 26.10.2007 | EN | Official Journal of the European Union | C 251/108 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/108

---

Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 1628/2006 on the application of Articles 87 and 88 of the Treaty to national regional investment aid

(Text with EEA relevance)

(2007/C 251/12)

| Aid No | XR 141/07 |
| --- | --- |
| Member State | Greece |
| Region | 87(3)(a), 87(3)(c) |
| Title of aid scheme or the name of the undertaking receiving ad hoc aid supplement | Kathestos enisxyseon gia poly mikres epixeiriseis, symfona me ti systasi tis Epitropis 2003/361/EC, gia ti metapoiisi h/kai eboria dasokomikon proionton, sto plasio efarmogis tou metrou 123 tou Axona I tou Programmatos Agrotikis Anaptyxis tis Elladas 2007-2013 |
| Legal basis | Ν. 2065/92, άρθρο 39 παρ.10 (ΦΕΚ 113/Α'/92) «περί εγκρίσεως οικονομικών ενισχύσεων από τους Υπουργούς Οικονομικών και Γεωργίας»
  Ν.Δ. 131/74, άρθρο 1, (ΦΕΚ 320/Α'/74) «Περί παροχής οικονομικών ενισχύσεων στη γεωργική, κτηνοτροφική, δασική και αλιευτική παραγωγή» όπως τροποποιήθηκε με το Ν.1409/86 και τον Ν.2512/97 (άρθρο 11) |
| Type of measure | Aid scheme |
| Annual budget | EUR 10 million |
| Maximum aid intensity | 50 % |
| In conformity with Article 4 of the Regulation |
| Date of implementation | 1.1.2008 |
| Duration | 31.12.2013 |
| Economic sectors | All sectors eligible for regional investment aid |
| Name and address of the granting authority | Ypourgeio Agrotikis Anaptyxis, Ypireisia Diaxeirisis EPA Anasygkrotisi ypaithrou |
| Τel. (30) 210 5275083 |
| E-mail: vskandalis@mnec.gr |

Aid No

XR 141/07

Member State

Greece

Region

87(3)(a), 87(3)(c)

Title of aid scheme or the name of the undertaking receiving ad hoc aid supplement

Kathestos enisxyseon gia poly mikres epixeiriseis, symfona me ti systasi tis Epitropis 2003/361/EC, gia ti metapoiisi h/kai eboria dasokomikon proionton, sto plasio efarmogis tou metrou 123 tou Axona I tou Programmatos Agrotikis Anaptyxis tis Elladas 2007-2013

Legal basis

Ν. 2065/92, άρθρο 39 παρ.10 (ΦΕΚ 113/Α'/92) «περί εγκρίσεως οικονομικών ενισχύσεων από τους Υπουργούς Οικονομικών και Γεωργίας»

Ν.Δ. 131/74, άρθρο 1, (ΦΕΚ 320/Α'/74) «Περί παροχής οικονομικών ενισχύσεων στη γεωργική, κτηνοτροφική, δασική και αλιευτική παραγωγή» όπως τροποποιήθηκε με το Ν.1409/86 και τον Ν.2512/97 (άρθρο 11)

Type of measure

Aid scheme

Annual budget

EUR 10 million

Maximum aid intensity

50 %

In conformity with Article 4 of the Regulation

Date of implementation

1.1.2008

Duration

31.12.2013

Economic sectors

All sectors eligible for regional investment aid

Name and address of the granting authority

Ypourgeio Agrotikis Anaptyxis, Ypireisia Diaxeirisis EPA Anasygkrotisi ypaithrou

Τel. (30) 210 5275083

E-mail: vskandalis@mnec.gr

Internet address of the publication of the aid scheme

www.agrotikianaptixi.gr

Other information

—

| Aid No | XR 160/07 |
| --- | --- |
| Member State | Romania |
| Region | — |
| Title of aid scheme or the name of the undertaking receiving ad hoc aid supplement | Schema de ajutor de stat regional acordat pentru investiţiile realizate în parcurile industriale |
| Legal basis | Ordinul ministrului internelor şi reformei administrative nr. 296/18.09.2007 |
| Type of measure | Aid scheme |
| Annual budget | RON 38 371 million |
| Maximum aid intensity | 50 % |
| In conformity with Article 4 of the Regulation |
| Date of implementation | 18.9.2007 |
| Duration | 31.12.2013 |
| Economic sectors | All sectors eligible for regional investment aid |
| Name and address of the granting authority | 1. | Toate unităţile administrativ teritoriale în raza cărora se situează parcuri industriale |

Aid No

XR 160/07

Member State

Romania

Region

—

Title of aid scheme or the name of the undertaking receiving ad hoc aid supplement

Schema de ajutor de stat regional acordat pentru investiţiile realizate în parcurile industriale

Legal basis

Ordinul ministrului internelor şi reformei administrative nr. 296/18.09.2007

Type of measure

Aid scheme

Annual budget

RON 38 371 million

Maximum aid intensity

50 %

In conformity with Article 4 of the Regulation

Date of implementation

18.9.2007

Duration

31.12.2013

Economic sectors

All sectors eligible for regional investment aid

Name and address of the granting authority

1.

Toate unităţile administrativ teritoriale în raza cărora se situează parcuri industriale

| 2. | Ministerul Agriculturii şi Dezvoltării Rurale |
| --- | --- |
| Bulevardul Carol I nr. 24, sector 3 |
| Bucureşti, România |
| Tel. (40-21) 307 24 24 |
| E-mail: relatii.publice@madr.ro |

2.

Ministerul Agriculturii şi Dezvoltării Rurale

Bulevardul Carol I nr. 24, sector 3

Bucureşti, România

Tel. (40-21) 307 24 24

E-mail: relatii.publice@madr.ro

| 3. | Agenţia Naţională de Cadastru şi Publicitate Imobiliară |
| --- | --- |
| Splaiul Independenţei 202 A, sector 6 |
| Bucureşti, România |
| Tel. (40-21) 317 31 62 |
| E-mail: relatiicupublicul@ancpi.ro |

3.

Agenţia Naţională de Cadastru şi Publicitate Imobiliară

Splaiul Independenţei 202 A, sector 6

Bucureşti, România

Tel. (40-21) 317 31 62

E-mail: relatiicupublicul@ancpi.ro

Internet address of the publication of the aid scheme

http://www.mai.gov.ro/index07_15_2.htm

Other information

—

| Aid No | XR 145/07 |
| --- | --- |
| Member State | The Netherlands |
| Region | 87(3)(c): Groningen, Friesland, Drenthe, Limburg |
| Title of aid scheme or the name of the undertaking receiving ad hoc aid supplement | Uitvoeringsregeling Besluit subsidies regionale investeringsprojecten 2007/2013 |
| Legal basis | Kaderwet EZ-subsidies |
| Type of measure | Aid scheme |
| Annual budget | EUR 13,5 million |
| In conformity with Article 4 of the Regulation |
| Date of implementation | 26.7.2007 |
| Duration | 31.12.2013 |
| Economic sectors | All sectors eligible for regional investment aid |
| Name and address of the granting authority | Ministerie van Economische Zaken |
| Bezuidenhoutseweg 30 |
| 2500 EC Den Haag |
| Nederland |
| Tel. (31) 70 379 66 06 |
| E-mail: i.g.hosper@minez.nl |

Aid No

XR 145/07

Member State

The Netherlands

Region

87(3)(c): Groningen, Friesland, Drenthe, Limburg

Title of aid scheme or the name of the undertaking receiving ad hoc aid supplement

Uitvoeringsregeling Besluit subsidies regionale investeringsprojecten 2007/2013

Legal basis

Kaderwet EZ-subsidies

Type of measure

Aid scheme

Annual budget

EUR 13,5 million

In conformity with Article 4 of the Regulation

Date of implementation

26.7.2007

Duration

31.12.2013

Economic sectors

All sectors eligible for regional investment aid

Name and address of the granting authority

Ministerie van Economische Zaken

Bezuidenhoutseweg 30

2500 EC Den Haag

Nederland

Tel. (31) 70 379 66 06

E-mail: i.g.hosper@minez.nl

Internet address of the publication of the aid scheme

www.overheid.nl

Other information

—

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V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 26.10.2007 | EN | Official Journal of the European Union | C 251/110 |
| --- | --- | --- | --- |

26.10.2007

EN

Official Journal of the European Union

C 251/110

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Prior notification of a concentration

(Case COMP/M.4936 — BENTELER/SGLT/JV)

(Text with EEA relevance)

(2007/C 251/13)

| 1. | On 17 October 2007, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Benteler Automobiltechnik GmbH (‘BENTELER’, Germany) and SGL Technologies GmbH (‘SGLT’, Germany) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control by way of purchase of shares in a newly created company, BENTELER-SGL Automotive Carbon Composites GmbH & Co. KG (‘the JV’), constituting a joint venture. |
| --- | --- |

1.

On 17 October 2007, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Benteler Automobiltechnik GmbH (‘BENTELER’, Germany) and SGL Technologies GmbH (‘SGLT’, Germany) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control by way of purchase of shares in a newly created company, BENTELER-SGL Automotive Carbon Composites GmbH & Co. KG (‘the JV’), constituting a joint venture.

| 2. | The business activities of the undertakings concerned are:






  — | for BENTELER: development and production of automotive components, modules and systems for ride and handling, safety and emission, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for BENTELER: development and production of automotive components, modules and systems for ride and handling, safety and emission,

| — | for SGLT: production of carbon fibers, aerospace and industrial composites, expanded graphite, carbon ceramic brake discs and fuel cell components, |
| --- | --- |

—

for SGLT: production of carbon fibers, aerospace and industrial composites, expanded graphite, carbon ceramic brake discs and fuel cell components,

| — | for the JV: development, production and distribution of components for the automotive industry using carbon fiber reinforced plastics and carbon fiber reinforced plastics hybrid structures. |
| --- | --- |

—

for the JV: development, production and distribution of components for the automotive industry using carbon fiber reinforced plastics and carbon fiber reinforced plastics hybrid structures.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4936 — BENTELER/SGLT/JV to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4936 — BENTELER/SGLT/JV to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

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(1)  OJ L 24, 29.1.2004, p. 1.

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