In other countries
The same active substances on other registers, the same brand first.
- SingulairBrazil · Organon Farmacêutica Ltda.Same brand
- SingulairCanada · 4 MG · Tablet (Chewable) · Organon Canada INC.Same brand
- SingulairCanada · 10 MG · Tablet · Organon Canada INC.Same brand
- SingulairCanada · 5 MG · Tablet (Chewable) · Organon Canada INC.Same brand
- Singulair 10 mg filmom obložene tableteCroatia · filmom obložena tableta · Organon Pharma d.o.o., Slavonska Avenija 1c, Zagreb, HrvatskaSame brand
- Singulair junior 5 mg tablete za žvakanjeCroatia · tableta za žvakanje · Organon Pharma d.o.o., Slavonska Avenija 1c, Zagreb, HrvatskaSame brand
- Singulair mini 4 mg tablete za žvakanjeCroatia · tableta za žvakanje · Organon Pharma d.o.o., Slavonska Avenija 1c, Zagreb, HrvatskaSame brand
- SingulairItaly · Compressa masticabile · GMM Farma S.R.L.Same brand
- SingulairItaly · Compressa rivestita con film · BB Farma S.R.L.Same brand
- SingulairItaly · Compressa rivestita con film · Farma 1000 S.R.L.Same brand
- Singulair 10 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · N.V. OrganonSame brand
- Singulair 4 mg kauwtablettenNetherlands · Kauwtablet · N.V. OrganonSame brand
- Singulair 5 mg kauwtablettenNetherlands · Kauwtablet · N.V. OrganonSame brand
- SINGULAIR 10 mgRomania · 10mg · compr. film. · Merck Sharp & Dohme Romania S.R.L.Same brand
- SINGULAIR 4 mgRomania · 4mg · compr. mast. · Merck Sharp & Dohme Romania S.R.L.Same brand
- SINGULAIR 5 mgRomania · 5mg · compr. mast. · Merck Sharp & Dohme Romania S.R.L.Same brand
- Singulair®Serbia · 4mg · tableta za žvakanje · Organon D.O.O.Same brand
- Singulair®Serbia · 10mg · film tableta · Organon D.O.O.Same brand
- Singulair®Serbia · 10mg · film tableta · Organon D.O.O.Same brand
- Singulair Paediatric 4 MG Chewable TabSaudi Arabia · Merck Sharp & DohmeSame brand
- SingulairSaudi Arabia · Merck Sharp & DohmeSame brand
- Singulair Pediatric 4MG GranulesSaudi Arabia · Patheon Manufacturing Services LLCSame brand
- SINGULAIR CHEWABLE TABLET 4 mgSingapore · 4 mg · tablet, film coated · Organon Singapore Pte. LTD.Same brand
- SINGULAIR CHEWABLE TABLET 5 mgSingapore · 5 mg · tablet · Organon Singapore Pte. LTD.Same brand
- SINGULAIR TABLET 10 mgSingapore · 10 mg · tablet · Organon Singapore Pte. LTD.Same brand
- SingulairUnited States · 4MG BASE, 5MG BASE · tablet, chewable · OrganonSame brand
- SingulairUnited States · 10MG BASE · tablet · OrganonSame brand
- SingulairUnited States · 4MG BASE/PACKET · granule · OrganonSame brand
- Montelukast Paediatric (Relonchem)New Zealand · Tab 5 mgSame form
- Montelukast (Sandoz)New Zealand · Tab 4 mgSame form
- Montelukast ViatrisNew Zealand · Tab 4 mgSame form
- ÁriaBrazil · Eurofarma Laboratorios S.A.Same substance
- Fischio®Brazil · Biolab Sanus Farmacêutica LtdaSame substance
- Monte-H 5 (Montelukast Chewable Tablets 5mg)Taiwan · 咀嚼錠 · 凱沛爾藥品有限公司Same substance
- Sinlue Chewable Tablets 5mgTaiwan · 咀嚼錠 · 恆準醫藥有限公司Same substance
Packs
| Pack | Code | Status |
|---|---|---|
| SINGULAIR 5mg COMPRIMIDOS MASTICABLES, 28 comprimidos | 715485 |
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.
Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026
Report an error or request removalCorrections from the holder or the register are welcome.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Active substance
- Montelukast
- Strength
- 5 mg
- Dosage form
- comprimido masticable
- Route
- vía oral
- Register
- Spain (AEMPS)
- Status
- Marketed
- Status in the register
- Autorizado, comercializado
- Authorised
- 27 Mar 2017
- Registration
- 7956IP1
- Marketing authorisation holder
- Organon Polska Sp. Z O.O.
- Procedure
- National, MRP or DCP
- Supply
- Medicamento Sujeto A Prescripción Médica