01 September 2017 EMA/596710/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance: beclometasone / salbutamol

Procedure no.: PSUSA/00000309/201701

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Product Name (in authorisation

MRP/DCP

National Authorisation

MAH of product in the

Member State

country)

Authorisation

Number

Member State

where product is

number BUTOSOL 100 microgramos/50 microgramos / pulsación suspensión para inhalación en envase a presión C LENIL C OMPOSITUM 0,8 mg + 1,6 mg sospensione da nebulizzare C LENIL C OMPOSITUM 0,8 mg + 1,6 mg sospensione da nebulizzare C LENIL® C OMPOSITUM 250 MC G + 100 MC G SOSPENSIONE PRESSURIZZATA PER INALAZIONE C LENIL® C OMPOSITUM 50 MC G + 100 MC G SOSPENSIONE PRESSURIZZATA PER INALAZIONE C LENIL® C OMPOSITUM 50 mcg + 100 mcg sospensione pressurizzata per inalazione Sabacomb 250 Mikrogramm + 100 Mikrogramm pro Sprühstoß – Druckgasinhalation, Suspension Sabacomb 250 mikrogramm/ 100 mikrogramm túlnyomásos inhalációs szuszpenzió Sabacomb, 100/250 mikrogrammi/pihustuses inhalatsiooniaerosool, suspensioon

L is t of nationally authorised medicinal products E MA/596710/2017

authorised

not available

55.497

LABORATORIO ALDOUNIÓN, S.L.

ES

not available

023440050

PROMEDIC A S.R.L.

IT

not available

023440086

PROMEDIC A S.R.L.

IT

not available

023440062

PROMEDIC A S.R.L.

IT

not available

023440074

PROMEDIC A S.R.L.

IT

not available

023440011

PROMEDIC A S.R.L.

IT

not available

135963

C HIESI PHARMAC EUTIC ALS GMBH

AT

not available

OGYI-T-22713/01

C HIESI PHARMAC EUTIC ALS GMBH

HU

not available

898815

C HIESI PHARMAC EUTIC ALS GMBH

EE

P age 2 /2