11 January 2018 EMA/24780/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: buspirone

Procedure no.: PSUSA/00000463/201704

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Product Name (in authorisation country)

MRP/DCP Authorisation number not available

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

9767830

PT

ANSITEN®, 10 mg comprimidos

not available

9767822

ANSITEN®, 10 mg comprimidos

not available

9767830

ANSITEN®, 10 mg comprimidos

not available

9767822

ANSITEN®, 5 mg comprimidos

not available

9767814

ANSITEN®, 5 mg comprimidos

not available

9767806

ANSITEN®, 5 mg comprimidos

not available

9767814

ANSITEN®, 5 mg comprimidos

not available

9767806

Anxut® 10 mg Tabletten Anxut® 5 mg Tabletten BESPAR® BESPAR® BUSPAR TABLETS 10MG

not not not not not

available available available available available

11424.01.00 11424.00.00 293 27648 PL 20075/0558

BUSPAR TABLETS 5MG

not available

PL 20075/0559

Itagil 10 mg comprimido

not available

4509584

Itagil 10 mg comprimido

not available

8776732

Itagil 5 mg comprimido

not available

8776708

LABORATÓRIOS AZEVEDOS INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS INDÚSTRIA FARMACÊUTICA, S.A. EISAI GMBH EISAI GMBH VIANEX S.A. VIANEX S.A. ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED AUROVITAS UNIPESSOAL, LDA. AUROVITAS UNIPESSOAL, LDA. AUROVITAS UNIPESSOAL, LDA.

ANSITEN®, 10 mg comprimidos

List of nationally authorised medicinal products EMA/24780/2018

PT PT PT PT PT PT PT DE DE GR GR UK UK PT PT PT

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Product Name (in authorisation country) Itagil 5 mg comprimido

MRP/DCP Authorisation number not available

List of nationally authorised medicinal products EMA/24780/2018

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

8776716

AUROVITAS UNIPESSOAL, LDA.

PT

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