# C_2013380EN.01001101.xml

| 28.12.2013 | EN | Official Journal of the European Union | C 380/11 |
| --- | --- | --- | --- |

28.12.2013

EN

Official Journal of the European Union

C 380/11

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2013 to 30 November 2013

(decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1)
  or Article 38 of Directive 2001/82/EC
   (2)
  )

(decisions taken pursuant to Article 34 of Directive 2001/83/EC

1

or Article 38 of Directive 2001/82/EC

2

)

2013/C 380/02

—   Issuing, maintenance or modification of a national marketing authorization

Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 20.11.2013 | Didanosine Art 29 | See Annex I | See Annex I | 22.11.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

20.11.2013

Didanosine Art 29

See Annex I

See Annex I

22.11.2013

---

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

1

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

2

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ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES

| Member State EU/EEA | Applicant company name, address | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| France | Aurobindo Pharma (Malta) Limited, |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Member State EU/EEA

Applicant company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

France

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

DIDANOSINE AUROBINDO 200 mg, gélule gastro-résistante

200 mg

Gastro-resistant capsule, hard

Oral use

France

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

DIDANOSINE AUROBINDO 250 mg, gélule gastro-résistante

250 mg

Gastro-resistant capsule, hard

Oral use

France

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

DIDANOSINE AUROBINDO 400 mg, gélule gastro-résistante

400 mg

Gastro-resistant capsule, hard

Oral use

Germany

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosin Aurobindo 200 mg magensaftresistente Hartkapseln

200 mg

Gastro-resistant capsule, hard

Oral use

Germany

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosin Aurobindo 250 mg magensaftresistente Hartkapseln

250 mg

Gastro-resistant capsule, hard

Oral use

Germany

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosin Aurobindo 400 mg magensaftresistente Hartkapseln

400 mg

Gastro-resistant capsule, hard

Oral use

Italy

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosina Aurobindo 200 mg capsule rigide gastroresistenti

200 mg

Gastro-resistant capsule, hard

Oral use

Italy

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosina Aurobindo 250 mg capsule rigide gastroresistenti

250 mg

Gastro-resistant capsule, hard

Oral use

Italy

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosina Aurobindo 400 mg capsule rigide gastroresistenti

400 mg

Gastro-resistant capsule, hard

Oral use

Netherlands

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosine Aurobindo 250 mg maagsapresistente capsules, hard

250 mg

Gastro-resistant capsule, hard

Oral use

Netherlands

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosine Aurobindo 400 mg maagsapresistente capsules, hard

400 mg

Gastro-resistant capsule, hard

Oral use

Portugal

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosina Aurobindo

250 mg

Gastro-resistant capsule, hard

Oral use

Portugal

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosina Aurobindo

400 mg

Gastro-resistant capsule, hard

Oral use

Romania

| Aurobindo Pharma (Malta) Limited |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913 |
| Malta |

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913

Malta

Didanosine Aurobindo 250 mg capsule gastrorezistente

250 mg

Gastro-resistant capsule, hard

Oral use

Romania

| Aurobindo Pharma (Malta) Limited |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913 |
| Malta |

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913

Malta

Didanosine Aurobindo 400 mg capsule gastrorezistente

400 mg

Gastro-resistant capsule, hard

Oral use

Spain

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

DIDANOSINA AUROBINDO 250 mg cápsulas duras gastrorresistentes

250 mg

Gastro-resistant capsule, hard

Oral use

Spain

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

DIDANOSINA AUROBINDO 400 mg cápsulas duras gastrorresistentes

400 mg

Gastro-resistant capsule, hard

Oral use

United Kingdom

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosine 200 mg gastro-resistant capsules, hard

200 mg

Gastro-resistant capsule, hard

Oral use

United Kingdom

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosine 250 mg gastro-resistant capsules, hard

250 mg

Gastro-resistant capsule, hard

Oral use

United Kingdom

| Aurobindo Pharma (Malta) Limited, |
| --- |
| Vault 14, Level 2, |
| Valletta Waterfront, |
| Floriana FRN 1913, |
| Malta |

Aurobindo Pharma (Malta) Limited,

Vault 14, Level 2,

Valletta Waterfront,

Floriana FRN 1913,

Malta

Didanosine 400 mg gastro-resistant capsules, hard

400 mg

Gastro-resistant capsule, hard

Oral use

---